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2. Effect of Semaglutide on Regression and Progression of Glycemia in People With Overweight or Obesity but Without Diabetes in the SELECT Trial.

Author

Kahn, Steven E., Deanfield, John E., Jeppesen, Ole Kleist, Emerson, Scott S., Boesgaard, Trine Welløv, Colhoun, Helen M., Kushner, Robert F., Lingvay, Ildiko, Burguera, Bartolome, Gajos, Grzegorz, Horn, Deborah Bade, Hramiak, Irene M., Jastreboff, Ania M., Kokkinos, Alexander, Maeng, Michael, Matos, Ana Laura S.A., Tinahones, Francisco J., Lincoff, A. Michael, and Ryan, Donna H.

Subjects
SEMAGLUTIDE, OVERWEIGHT persons, HYPERGLYCEMIA, DIABETES, CARDIOVASCULAR diseases, OBESITY, BODY weight
Abstract

OBJECTIVE: To determine whether semaglutide slows progression of glycemia in people with cardiovascular disease and overweight or obesity but without diabetes. RESEARCH DESIGN AND METHODS: In a multicenter, double-blind trial, participants aged ≥45 years, with BMI ≥27 kg/m2, and with preexisting cardiovascular disease but without diabetes (HbA1c <6.5%) were randomized to receive subcutaneous semaglutide (2.4 mg weekly) or placebo. Major glycemic outcomes were HbA1c and proportions achieving biochemical normoglycemia (HbA1c <5.7%) and progressing to biochemical diabetes (HbA1c ≥6.5%). RESULTS: Of 17,604 participants, 8,803 were assigned to semaglutide and 8,801 to placebo. Mean ± SD intervention exposure was 152 ± 56 weeks and follow-up 176 ± 40 weeks. In both treatment arms mean nadir HbA1c for participants was at 20 weeks. Thereafter, HbA1c increased similarly in both arms, with a mean difference of −0.32 percentage points (95% CI −0.33 to −0.30; −3.49 mmol/mol [−3.66 to −3.32]) and with the difference favoring semaglutide throughout the study (P < 0.0001). Body weight plateaued at 65 weeks and was 8.9% lower with semaglutide. At week 156, a greater proportion treated with semaglutide were normoglycemic (69.5% vs. 35.8%; P < 0.0001) and a smaller proportion had biochemical diabetes by week 156 (1.5% vs. 6.9%; P < 0.0001). The number needed to treat was 18.5 to prevent a case of diabetes. Both regression and progression were dependent on glycemia at baseline, with the magnitude of weight reduction important in mediating 24.5% of progression and 27.1% of regression. CONCLUSIONS: In people with preexisting cardiovascular disease and overweight or obesity but without diabetes, long-term semaglutide increases regression to biochemical normoglycemia and reduces progression to biochemical diabetes but does not slow glycemic progression over time. 6357437865112 dc240491video1 Video 1. This image is from a video available online at https://bcove.video/3WedKuq. American Diabetes Association 84th Scientific Sessions: SELECT Trial—New Looks at Glycemia, Inflammation, and Heart Failure. [ABSTRACT FROM AUTHOR]

Published
2024
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6. Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial

Author

Laurenzi, Andrea, Caretto, Amelia, Slatterly, David, Henderson-Wilson, Marcia, Weisnagel, S. John, Dubé, Marie-Christine, Julien, Valérie-Ève, Trevisan, Roberto, Lepore, Giuseppe, Bellante, Rosalia, Hramiak, Irene, Spaic, Tamara, Driscoll, Marsha, Borot, Sophie, Clergeot, Annie, Khiat, Lamia, Hammond, Peter, Ray, Sutapa, Dinning, Laura, Tonolo, Giancarlo, Manconi, Alberto, Ledda, Maura Serena, de Ranitz, Wendela, Silvius, Bianca, Wojtusciszyn, Anne, Farret, Anne, Vriesendorp, Titia, Immeker-de Jong, Folkje, van der Linden, Joke, Brink, Huguette S., Alkemade, Marije, Schaepelynck-Belicar, Pauline, Galie, Sébastien, Tréglia, Clémence, Benhamou, Pierre-Yves, Haddouche, Myriam, Hoogma, Roel, Leelarathna, Lalantha, Shaju, Angel, James, Linda, Bosi, Emanuele, Choudhary, Pratik, de Valk, Harold W, Lablanche, Sandrine, Castañeda, Javier, de Portu, Simona, Da Silva, Julien, Ré, Roseline, Vorrink-de Groot, Linda, Shin, John, Kaufman, Francine R, and Cohen, Ohad

Published
2019
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9. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial

Author

Proietto, Joseph, Stranks, Stephen, Chen, Roger, O'Neal, David, Pape, Alexia, Forbes, Mark, Morbey, Claire, Luger, Anton, Hanusch, Ursula, Schnack, Christoph, Fliesser-Goerzer, Evelyn, Hoelzl, Bertram, Ebenbichler, Christoph, Prager, Rudolf, Van Gaal, Luc, Vercammen, Chris, Scheen, Andre, Mathieu, Chantal, Duyck, Francis, Nobels, Frank, Ruige, Johannes, Aggarwal, Naresh, Woo, Vincent, St-Pierre, Bruno, Dumas, Richard, Hramiak, Irene, Elliott, Thomas, Krarup Hansen, Troels, Henriksen, Jan Erik, Gram, Jeppe, Lihn, Aina, Bruun, Jens, Saltevo, Juha, Taurio, Jyrki, Strand, Jorma, Valle, Timo, Nieminen, Sakari, Pietilainen, Kirsi, Guerci, Bruno, Hadjadj, Samy, Cariou, Bertrand, Verges, Bruno, Borot, Sophie, Penfornis, Alfred, Schaum, Thomas, Tschoepe, Diethelm, Marck, Cornelia, Horacek, Thomas, Rose, Ludger, Klausmann, Gerhard, Luedemann, Joerg, Appelt, Steffi, Aigner, Ulrich, Goebel, Rolf, Behnke, Thomas, Ziegler, Anette-Gabriele, Peterfai, Eva, Kerenyi, Zsuzsanna, Oroszlan, Tamas, Kiss, Gyula G., Konyves, Laszlo, Piros, Gyorgyi, Phillip, Moshe, Mosenzon, Ofri, Shehadeh, Naim, Adawi, Faiad, Wainstein, Julio, Dotta, Francesco, Piatti, Piermarco, Genovese, Stefano, Consoli, Agostino, Di Bartolo, Paolo, Mannucci, Edoardo, Giordano, Carla, Lapolla, Annunziata, Aguilar, Carlos, Esteban, Alberto, Ruiz, Bazzoni, Ramirez, Guillermo Mondragon, Pelayo Orozco, Emilia, Alejandro, Carlos, de Alba, Stobschinski, Medina Pech, Carlos, Garza Ruiz, Jose, Sauque Reyna, Leobardo, Llamas Esperon, Guillermo, Nevarez Ruiz, Luis Alejandro, Vidrio Velazquez, Maricela, Flores Lozano, Fernando, Gonzalez Gonzalez, Jose Gerardo, Garcia-Hernandez, Pedro Alberto, Araujo-Silva, Roberto, Villeda - Espinosa, Efrain, Mistodie, Cristina, Popescu, Daniela, Constantin, Ciprian, Nicolau, Alina, Popa, Bogdan, Timar, Romulus, Serafinceanu, Cristian, Pintilei, Ella, Soto, Alfonso, Gimenez, Margarita, Merino-Torres, Juan Francisco, Morales, Cristobal, Mezquita, Pedro, Jendle, Johan, Tengmark, Bengt-Olov, Eriksson, Jan, Londahl, Magnus, Eliasson, Bjorn, Gunstone, Anthony, Heller, Simon, Darzy, Ken, Mansell, Peter, Davies, Melanie, Reed, Rory, Browne, Duncan, Courtney, Hamish, Turner, Wayne, Blagden, Mark, McCrimmon, Rory, Bergenstal, Richard, Lane, Wendy, Lucas, Kathryn, White, Alexander, Bao, Shichun, White, Judith, Jantzi, Curtis, Rasouli, Neda, Ervin, William, Lewy-Alterbaum, Lorena, Handelsman, Yehuda, Miranda-Palma, Bresta, Cleland, Alan, Fink, Raymond, Rodbard, Helena, Nakhle, Samer, Greenberg, Craig, Schorr, Alan, Bays, Harold, Simmons, Debra, Klein, Eric, Kane, Laurie, Fishman, Norman, Ipp, Eli, Garg, Satish, Bhargava, Anuj, Singh, Michelle Zaniewski, Rosenstock, Julio, Thrasher, James, Warren, Mark, Young, Laura, Aroda, Vanita, Pettus, Jeremy, Liljenquist, David, Busch, Robert, Dandona, Paresh, Wise, Jonathan, Kayne, David, Biggs, William, Hansen, Lars, Griffen, Steven C, Tschöpe, Diethelm, Thorén, Fredrik, Xu, John, and Langkilde, Anna Maria

Published
2017
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11. Cardiovascular and metabolic effects of metformin in patients with type 1 diabetes (REMOVAL): a double-blind, randomised, placebo-controlled trial

Author

Nickerson, H, Lou, O, Dutta, S, Haw, J, Anderson, C, Kean, S, Thomson, E, Gillespie, L, Gibb, J, Greenlaw, N, Keech, A, Jenkins, A, March, K, Williams, S, Coady, E, Bots, M, Dreyer, J, Jan, T, Sheffy, K, Lusky, R, Peleg, S, Shore, A, Carty, D, Donnan, P, Witham, M, Adler, A, Lonn, E, Rauchhaus, P, Lindsay, R, Brouwers, M, Van-Melckebeke, J, Hamill, T, Cuthbertson, L, Murray, A, Jolly, L, Miller, E, Hair, J, Bell, A, Carmichael, S, Douglas, E, Surtees, P, Dinnett, E, Allan, J, Watson, C, McLaughlin, M, Brindley, G, Smillie, E, Motherwell, D, MacDonald, S, Ellis, P, Stuart, D, Travers, M, Brearley, S, Greig, L, Colman, P, Nankervis, A, Forulanos, S, West, D, Vaughan, S, Bjorasen, M, Donlan, J, Vrazas, J, O'Neal, D, Horsburgh, J, Pater, H, Kent, S, Twigg, S, Fulcher, G, Denner, R, Piotrowicz, A, Januszewski, A, Coy, A, Paul, T, McDonald, C, Tereschyn, S, Schmidt, N, Weingert, M, Heard, H, Burke, S, Ooi, TC, Lochnan, H, Sorisky, A, Keely, E, Malcolm, J, Maranger, J, Favreau, C, Petherick, S, Boles, K, Rossing, P, Hansen, TW, Lund, S, Hemmingsen, B, Thorogood, N, Green, K, Robinson, T, Abouglilia, K, Nayman, D, Miller, C, Warren, R, Aizawa, K, Balasubramani, M, Toth, S, Harvey, K, Birch, G, Atkin, S, Sathyapalan, T, James, A, Javed, Z, Wilding, J, Martin, B, Birch, S, Wilcox, A, Watson, N, Oliver, N, Jugnee, N, Rutter, M, Turgut, T, Shaju, A, Yau, S, Subin, S, Walker, M, Wake, D, Millward, A, Chong, P, Hibbert, M, George, J, Schaper, N, Pinxt, J, op het Roodt, J, Phillips, Sam, Murray, L, Sleigh, L, Collier, A, Sit, LE, Allan, K, Cook, J, Campbell, K, Hodge, L, Leese, G, Reekie, G, Jaap, A, Sudworth, A, White, A, McKnight, J, Steven, L, McKay, G, Llano, A, Currie, G, Lennon, E, Johnstone, J, Shields, K, Petrie, John R, Chaturvedi, Nishi, Ford, Ian, Brouwers, Martijn C G J, Greenlaw, Nicola, Tillin, Therese, Hramiak, Irene, Hughes, Alun D, Jenkins, Alicia J, Klein, Barbara E K, Klein, Ronald, Ooi, Teik C, Rossing, Peter, Stehouwer, Coen D A, Sattar, Naveed, and Colhoun, Helen M

Published
2017
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12. Diabetes remission and relapse following an intensive metabolic intervention combining insulin glargine/lixisenatide, metformin and lifestyle approaches: Results of a randomised controlled trial.

Author

McInnes, Natalia, Hall, Stephanie, Lochnan, Heather A., Harris, Stewart B., Punthakee, Zubin, Sigal, Ronald J., Hramiak, Irene, Azharuddin, Mohammed, Liutkus, Joanne F., Yale, Jean‐François, Sultan, Farah, Smith, Ada, Otto, Rose E., Sherifali, Diana, Liu, Yan Yun, and Gerstein, Hertzel C.

Subjects
METFORMIN, DISEASE remission, INSULIN, RANDOMIZED controlled trials, TYPE 2 diabetes, GLYCOSYLATED hemoglobin
Abstract

Aim: Non‐surgical options for inducing type 2 diabetes remission are limited. We examined whether remission can be achieved by combining lifestyle approaches and short‐term intensive glucose‐lowering therapy. Methods: In this trial, 160 patients with type 2 diabetes on none to two diabetes medications other than insulin were randomised to (a) an intervention comprising lifestyle approaches, insulin glargine/lixisenatide and metformin, or (b) standard care. Participants with glycated haemoglobin (HbA1c) <7.3% (56 mmol/mol) at 12 weeks were asked to stop diabetes medications and were followed for an additional 52 weeks. The primary outcome was diabetes relapse defined as HbA1c ≥6.5% (48 mmol/mol) at 24 weeks or thereafter, capillary glucose ≥10 mmol/L on ≥50% of readings, or use of diabetes medications, analysed as time‐to‐event. Main secondary outcomes included complete or partial diabetes remission at 24, 36, 48 and 64 weeks defined as HbA1c <6.5% (48 mmol/mol) off diabetes medications since 12 weeks after randomisation. A hierarchical testing strategy was applied. Results: The intervention significantly reduced the hazard of diabetes relapse by 43% (adjusted hazard ratio 0.57, 95% confidence interval 0.40‐0.81; p =.002). Complete or partial diabetes remission was achieved in 30 (38.0%) intervention group participants versus 16 (19.8%) controls at 24 weeks and 25 (31.6%) versus 14 (17.3%) at 36 weeks [relative risk 1.92 (95% confidence interval 1.14‐3.24) and 1.83 (1.03‐3.26), respectively]. The relative risk of diabetes remission in the intervention versus control group was 1.88 (1.00‐3.53) at 48 weeks and 2.05 (0.98‐4.29) at 64 weeks. Conclusions: A 12‐week intensive intervention comprising insulin glargine/lixisenatide, metformin and lifestyle approaches can induce remission of diabetes. [ABSTRACT FROM AUTHOR]

Published
2023
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16. Ease of Use of the iGlarLixi SoloStar Pen from the LixiLan ONE CAN Pen Sub-Study: Questionnaire Findings from People Living with Type 2 Diabetes and Their HealthCare Providers

Author

Yale, Jean-François, primary, Roborel de Climens, Aude, additional, Aggarwal, Naresh, additional, Dex, Terry, additional, Gerstein, Hertzel C., additional, Harris, Stewart, additional, Hramiak, Irene, additional, Stewart, John, additional, and Leiter, Lawrence A., additional

Published
2022
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22. Lixilan ONE CAN: Randomisierte Studie zum Vergleich eines täglichen vs. wöchentlichen Titrationsalgorithmus für den Wechsel von Basalinsulin zur Fixkombination iGlarLixi bei Typ-2-Diabetespatienten in Kanada

Author

Hramiak, Irene, additional, Gerstein, Hertzel C., additional, Siegmund, Thorsten, additional, Leiter, Lawrence A., additional, Yale, Jean-François, additional, Bajaj, Harpreet, additional, Stewart, John, additional, Toutounji, Marie-Josée, additional, and Harris, Stewart B., additional

Published
2022
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24. Effectiveness of Nonmydriatic Ultra-Widefield Retinal Imaging to Screen for Diabetic Eye Disease: A Randomized Controlled Trial (Clearsight).

Author

Liu, Selina L., Gonder, John R., Owrangi, Ehsan, Klar, Neil S., Hramiak, Irene M., Uvarov, Artem, and Mahon, Jeffrey L.

Abstract

Objective: Suboptimal diabetic eye disease screening is a major cause of preventable vision loss. Screening barriers include mydriasis and the need for dedicated screening appointments. The Clearsight trial assessed whether nonmydriatic ultra-widefield (NM UWF) screening on the day of a diabetes clinic visit improved detection of clinically important eye disease versus usual screening.Research Design and Methods: This single-center, randomized, parallel-group controlled trial was conducted at St. Joseph's Health Care, London, Ontario, Canada. Adults with diabetes due for screening were randomized to same-day, on-site screening (NM UWF imaging) on the day of a scheduled diabetes clinic visit or usual screening (encouraged to arrange optometrist screening). The primary outcome was detection of actionable eye disease (AED), defined as the need for an ophthalmology referral or increased ocular surveillance. The primary analysis (modified intention-to-screen) compared the proportions of AED between groups within 1 year of enrollment.Results: Of 740 participants randomized between 7 March 2016 and 17 April 2019, 335 on-site screening and 323 usual screening participants met criteria for the primary analysis. More AED was detected in the on-site screening group than in the usual screening group (50 of 335 [14.9%] vs. 22 of 323 [6.8%]; adjusted odds ratio 2.51; 95% CI 1.49-4.36). The number needed to screen by on-site screening in order to detect 1 additional patient with AED was 13 (95% CI 8-29).Conclusions: Same-day, on-site screening by NM UWF imaging increased the detection of clinically important diabetic eye disease versus usual screening. Integration of NM UWF imaging into routine diabetes clinic visits improved screening adherence and has the potential to prevent vision loss. [ABSTRACT FROM AUTHOR]

Published
2023
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26. Remission of type 2 diabetes following a short-term intensive intervention with insulin glargine, sitagliptin and metformin: results of an open-label randomized parallel-design trial

Author

McInnes, Natalia, primary, Hall, Stephanie, primary, Hramiak, Irene, primary, Sigal, Ronald J., primary, Goldenberg, Ronald, primary, Gupta, Nikhil, primary, Rabasa-Lhoret, Remi, primary, Braga, Manoela, primary, Woo, Vincent, primary, Sultan, Farah, primary, Otto, Rose, primary, Smith, Ada, primary, Sherifali, Diana, primary, Liu, Yan Yun, primary, Gerstein, Hertzel C., primary, and Group, the REMIT-sita Collaborative, primary

Published
2021
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27. Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomised trial

Author

Ismail-Beigi, Faramarz, Craven, Timothy, Banerji, Mary Ann, Basile, Jan, Calles, Jorge, Cohen, Robert M, Cuddihy, Robert, Cushman, William C, Genuth, Saul, Grimm, Richard H, Jr, Hamilton, Bruce P, Hoogwerf, Byron, Karl, Diane, Katz, Lois, Krikorian, Armand, O'Connor, Patrick, Pop-Busui, Rodica, Schubart, Ulrich, Simmons, Debra, Taylor, Harris, Thomas, Abraham, Weiss, Daniel, and Hramiak, Irene

Published
2010
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28. Metformin and carotid intima-media thickness in never-smokers with type 1 diabetes: \ud the REMOVAL trial

Author

Timmons, Joseph G., Greenlaw, Nicola, Boyle, James G., Chaturvedi, Nish, Ford, Ian, Brouwers, Martin C.G.J., Tillin, Therese, Hramiak, Irene, Hughes, Alun D., Jenkins, Alicia J., Klein, Barbara E.K., Klein, Ron, Ooi, Teik C., Rossing, Peter, Stehouwer, Coen D.A., Sattar, Naveed, Colhoun, Helen M., and Petrie, John R.

Abstract

Aim: \ud To determine whether metformin's effects on carotid artery intima‐media thickness (cIMT) in type 1 diabetes differ according to smoking status.\ud \ud Methods: \ud Regression model effect estimates for the effect of metformin versus placebo (double‐blind) on carotid IMT were calculated as a subgroup analysis of the REMOVAL trial.\ud \ud Results: \ud In 428 randomized participants (227 never‐smokers, 201 ever‐smokers), averaged mean carotid IMT progression (per year) was reduced by metformin versus placebo in never‐smokers (−0.012 mm, 95% CI −0.021 to −0.002; p = .0137) but not in ever‐smokers (0.003 mm, 95% CI −0.008 to 0.014; p = .5767); and similarly in non‐current smokers (−0.008 mm, 95% CI −0.015 to −0.00001; p = .0497) but not in current smokers (0.013 mm, 95% CI −0.007 to 0.032; p = .1887). Three‐way interaction terms (treatment*time*smoking status) were significant for never versus ever smoking (p = .0373, prespecified) and non‐current versus current smoking (p = .0496, exploratory). Averaged maximal carotid IMT progression (per year) was reduced by metformin versus placebo in never‐smokers (−0.020 mm, 95% CI −0.034 to −0.006; p = .0067) but not in ever‐smokers (−0.006 mm, 95% CI −0.020 to 0.008; p = .4067), although this analysis was not supported by a significant three‐way interaction term.\ud \ud Conclusions: \ud This subgroup analysis of the REMOVAL trial provides additional support for a potentially wider role of adjunct metformin therapy in cardiovascular risk management in type 1 diabetes, particularly for individuals who have never smoked cigarettes.

Published
2021

30. 95-LB: LixilanONE CAN: Randomized Trial Comparing a Daily vs. Weekly Titration Algorithm for Switching from Basal Insulin to iGlarLixi Fixed-Ratio Combination in People with T2DM in Canada

Author

HRAMIAK, IRENE, primary, GERSTEIN, HERTZEL C., additional, LEITER, LAWRENCE A., additional, YALE, JEAN-FRANÇOIS, additional, BAJAJ, HARPREET S., additional, STEWART, JOHN A., additional, TOUTOUNJI, MARIE-JOSEE, additional, and HARRIS, STEWART B., additional

Published
2021
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35. Remission of Type 2 Diabetes Following a Short-term Intensive Intervention With Insulin Glargine, Sitagliptin, and Metformin: Results of an Open-label Randomized Parallel-Design Trial.

Author

McInnes, Natalia, Hall, Stephanie, Hramiak, Irene, Sigal, Ronald J., Goldenberg, Ronald, Gupta, Nikhil, Rabasa-Lhoret, Remi, Braga, Manoela, Woo, Vincent, Sultan, Farah, Otto, Rose, Smith, Ada, Sherifali, Diana, Yan Yun Liu, and Gerstein, Hertzel C.

Subjects
TYPE 2 diabetes, INSULIN therapy, SITAGLIPTIN, BLOOD sugar, GLUCOSE tolerance tests
Abstract

Objective: The aim of the study was to evaluate remission of type 2 diabetes following a short-term intervention with insulin glargine, sitagliptin/metformin, and lifestyle approaches.Research Design and Methods: In this open multicenter trial, 102 patients with type 2 diabetes were randomized to 1) a 12-week intervention with sitagliptin/metformin, insulin glargine, and lifestyle therapy or 2) control group. Participants with HbA1c <7.3% (<56 mmol/mol) at 12 weeks were asked to stop diabetes medications and were followed for evidence of relapse over 52 weeks. Diabetes relapse criteria included HbA1c ≥6.5% (≥48 mmol/mol), ≥50% of capillary glucose readings >10 mmol/L over 1 week, and reinitiation of diabetes medications with or without abnormal fasting plasma glucose (FPG) or 2-h plasma glucose on an oral glucose tolerance test (OGTT). Time-to-relapse analysis was conducted to compare the treatment groups with (primary analysis) and without (supplementary analysis) FPG/OGTT relapse criteria.Results: With the FPG/OGTT relapse criteria included, the hazard ratio (HR) of relapse was 0.72 (95% CI 0.47-1.10) in the intervention group compared with the control group (primary analysis), and the number of participants remaining in remission was not significantly different between treatment groups at 24, 36, 48, and 64 weeks. In the supplementary analyses without these criteria, HR of relapse was 0.60 (95% CI 0.39-0.95), and the number of participants remaining in remission was significantly higher (26 vs. 10%) in the intervention group at 36 weeks.Conclusions: Although our primary outcome was not statistically significant, the tested approach deserves further study with further optimization of its components. [ABSTRACT FROM AUTHOR]

Published
2022
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37. 490-P: Renal Effects of Metformin in Type 1 Diabetes (T1D): The REMOVAL Trial

Author

TIMMONS, JOSEPH G., primary, GREENLAW, NICOLA, additional, STEHOUWER, COEN D., additional, BROUWERS, MARTIJN, additional, CHATURVEDI, NISHI, additional, HUGHES, ALUN D., additional, HRAMIAK, IRENE, additional, JENKINS, ALICIA, additional, WELSH, PAUL, additional, SATTAR, NAVEED, additional, COLHOUN, HELEN M., additional, ROSSING, PETER, additional, and PETRIE, JOHN R., additional

Published
2020
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38. Allogenic Fecal Microbiota Transplantation in Patients With Nonalcoholic Fatty Liver Disease Improves Abnormal Small Intestinal Permeability: A Randomized Control Trial

Author

Craven, Laura, primary, Rahman, Adam, additional, Nair Parvathy, Seema, additional, Beaton, Melanie, additional, Silverman, Justin, additional, Qumosani, Karim, additional, Hramiak, Irene, additional, Hegele, Rob, additional, Joy, Tisha, additional, Meddings, Jon, additional, Urquhart, Brad, additional, Harvie, Ruth, additional, McKenzie, Charles, additional, Summers, Kelly, additional, Reid, Gregor, additional, Burton, Jeremy P., additional, and Silverman, Michael, additional

Published
2020
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41. Metformin in adults with type 1 diabetes

Author

Petrie, John R., Chaturvedi, Nish, Ford, Ian, Hramiak, Irene, Hughes, Alun D., Jenkins, Alicia J., E. Klein, Barbara, Klein, Ron, Ooi, Teik Chye, Rossing, Peter, Sattar, Naveed, Stehouwer, Coen D. A., Colhoun, Helen M., Ford, I, Kean, S, Thomson, E, Gillespie, L, Gibb, J, Greenlaw, N, Hramiak, I, Keech, A, Jenkins, A, Chaturvedi, N, Hughes, A, March, K, Coady, E, Tillin, T, Bots, M, Klein, R, Klein, B, Dreyer, J, Jan, T, Meuer, S, Murach, D, Sheffy, Koby, Lusky, Ravit, Peleg, S, Petrie, J, Colhoun, H, Shore, A, Carty, D, Donnan, P, Witham, M, Adler, A, Lonn, E, Rauchhaus, P, Lindsay, R, Brouwers, M, Van‐Melckebeke, J, Hamill, T, Cuthbertson, L, Murray, A, Jolly, L, Miller, E, Sattar, N, Hair, J, Bell, A, Carmichael, S, Douglas, E, Surtees, P, Dinnett, E, Allan, J, Watson, C, McLaughlin, M, Brindley, G, Smillie, E, Motherwell, D, MacDonald, S, Ellis, P, Stuart, D, Travers, M, Brearley, S, Greig, L, Haw, J, MUMC+: HVC Pieken Maastricht Studie (9), MUMC+: MA Interne Geneeskunde (3), RS: CARIM - R3.01 - Vascular complications of diabetes and the metabolic syndrome, and Interne Geneeskunde

Subjects
Blood Glucose, Male, Glycated Hemoglobin A, endocrine system diseases, type 1 diabetes, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Placebo-controlled study, PROGRESSION, 030204 cardiovascular system & hematology, PLACEBO-CONTROLLED TRIAL, Carotid Intima-Media Thickness, INTIMA-MEDIA THICKNESS, Glycated Hemoglobin A/drug effects, hypoglycaemia metformin, DISEASE, law.invention, 0302 clinical medicine, Endocrinology, Metformin/administration & dosage, Randomized controlled trial, Clinical Protocols, endothelial function, law, Risk Factors, GLYCEMIC CONTROL, Clinical endpoint, Insulin, Single-Blind Method, Non-U.S. Gov't, Research Support, Non-U.S. Gov't, cardiovascular, Diabetes, ACTIVATED PROTEIN-KINASE, Cardiovascular disease (CVD), clinical trial, ASSOCIATION, Middle Aged, Metformin, Multicenter Study, VITAMIN-B-12 DEFICIENCY, Cholesterol, Cholesterol, LDL/blood, Combination, Randomized Controlled Trial, POTENTIAL ROLE, Disease Progression, Original Article, Drug Therapy, Combination, Female, medicine.drug, Type 1, Adult, medicine.medical_specialty, complications, METFORMIN, 030209 endocrinology & metabolism, Hypoglycemia/chemically induced, METABOLISM, Placebo, Research Support, LDL, 03 medical and health sciences, Blood Glucose/drug effects, Drug Therapy, Double-Blind Method, Internal medicine, Internal Medicine, medicine, Diabetes Mellitus, Journal Article, Hypoglycemic Agents, Humans, carotid intima media thickness, Body Weight/drug effects, adjunct therapy, Glycated Hemoglobin, Type 1 diabetes, business.industry, Body Weight, nutritional and metabolic diseases, Atherosclerosis/drug therapy, Diabetes Mellitus, Type 1/blood, weight, Original Articles, Cholesterol, LDL, medicine.disease, Atherosclerosis, Hypoglycemic Agents/administration & dosage, Hypoglycemia, Surgery, Clinical trial, Diabetes Mellitus, Type 1, business, Insulin/administration & dosage
Abstract

Aims: Cardiovascular (CV) disease is a major cause of reduced life expectancy in type 1 diabetes (T1D). Intensive insulin therapy prevents CV complications but is constrained by hypoglycaemia and weight gain. Adjunct metformin reduces insulin dose requirement and stabilizes weight but there are no data on its cardiovascular effects. We have therefore initiated an international double-blind, randomized, placebo-controlled trial (REMOVAL: REducing with MetfOrmin Vascular Adverse Lesions in type 1 diabetes) to examine whether metformin reduces progression of atherosclerosis in adults with T1D. Individuals >= 40 years of age with T1D for >= 5 years are eligible if they have >= 3 of 10 specified CV risk factors. The enrolment target is 500 participants in 17 international centres.Materials and methods: After 12 weeks of single-blind placebo-controlled run-in, participants with >= 70% adherence are randomized to metformin or matching placebo for 3 years with insulin titrated towards HbA1c 7.0% (53 mmol/mol). The primary endpoint is progression of averaged mean far wall common carotid intima-media thickness (cIMT) measured by ultrasonography at baseline, 12, 24 and 36 months. This design provides 90% power to detect a mean difference of 0.0167 mm in cIMT progression between treatment arms (alpha = 0.05), assuming that up to 20% withdraw or discontinue treatment. Other endpoints include HbA1c, weight, LDL cholesterol, insulin requirement, progression of retinopathy, endothelial function and frequency of hypoglycaemia.Conclusion: REMOVAL is the largest clinical trial of adjunct metformin therapy in T1D to date and will provide clinically meaningful information on its potential to impact CV disease and other complications.

Published
2017

42. Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial

Author

Haddouche, Aini, Bellanne‐Chantelot, Christine, Rod, Anne, Fournier, Luc, Chiche, Laurence, Gautier, Jean‐Francois, Timsit, José, Laboureau, Sandrine, Chaillous, Lucy, Valero, Rene, Larger, Etienne, Jeandidier, Nathalie, Wilhelm, Jean‐Marie, Popelier, Marc, Guillausseau, Pierre‐Jean, Thivolet, Charles, Lecomte, Pierre, Benhamou, Pierre‐Yves, Reznik, Yves, Bosi, Emanuele, Choudhary, Pratik, De Valk, Harold, Lablanche, Sandrine, Castaneda, Javier, De Portu, Simona, Da Silva, Julien, Ré, Roseline, Vorrink-de Groot, Linda, Shin, John, Kaufman, Francine, Cohen, Ohad, Laurenzi, Andrea, Caretto, Amelia, Slatterly, David, Henderson-Wilson, Marcia, Weisnagel, S. John, Dubé, Marie-Christine, Julien, Valérie-Ève, Trevisan, Roberto, Lepore, Giuseppe, Bellante, Rosalia, Hramiak, Irene, Spaic, Tamara, Driscoll, Marsha, Borot, Sophie, Clergeot, Annie, Khiat, Lamia, Hammond, Peter, Ray, Sutapa, Dinning, Laura, Tonolo, Giancarlo, Manconi, Alberto, Ledda, Maura Serena, de Ranitz, Wendela, Silvius, Bianca, Wojtusciszyn, Anne, Farret, Anne, Vriesendorp, Titia, Immeker-de Jong, Folkje, van der Linden, Joke, Brink, Huguette, Alkemade, Marije, Schaepelynck-Belicar, Pauline, Galie, Sébastien, Tréglia, Clémence, Haddouche, Myriam, Hoogma, Roel, Leelarathna, Lalantha, Shaju, Angel, James, Linda, Institut National de l'Environnement Industriel et des Risques (INERIS), Service de Chirurgie digestive [Bordeaux], CHU Bordeaux [Bordeaux], Service de diabétologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition, Hôpital Laennec, Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Institut Cochin (IC UM3 (UMR 8104 / U1016)), Centre National de la Recherche Scientifique (CNRS)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Strasbourg, Pharmacologie Endocrinienne, Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Institut National de la Recherche Agronomique (INRA), Université de Liège, Centre Hospitalier Universitaire [Grenoble] (CHU), Laboratory of Fundamental and Applied Bioenergetics = Laboratoire de bioénergétique fondamentale et appliquée (LBFA), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Dipartimento di Biologia Evoluzionistica 'Leo Pardi', Università degli Studi di Firenze = University of Florence [Firenze] (UNIFI), King's College Hospital (KCH), University Medical Center [Utrecht], Medtronic Bakken Research Center BV, Medtronic Diabetes, International Trading Sàrl , Tolochenaz, Switzerland, Human Computer Technology Laboratory (HCTLab), Universidad Autonoma de Madrid (UAM), Service de Diabétologie - Endocrinologie [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Institute of Child Health, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Endocrinologie, Hôpital Sainte-Marguerite [CHU - APHM] (Hôpitaux Sud )-CHU Marseille, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Cochin [AP-HP], Hôpital de la Conception [CHU - APHM] (LA CONCEPTION ), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hôpital Lariboisière, Institut National de la Recherche Agronomique (INRA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire de bioénergétique fondamentale et appliquée (LBFA), Université Grenoble Alpes (UGA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Joseph Fourier - Grenoble 1 (UJF), Università degli Studi di Firenze [Firenze], Service de diabétologie - endocrinologie, Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon)-Hôpital Jean Minjoz, Service de diabétologie - endocrinologie [Besançon], Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon)-Hôpital Jean Minjoz-Université de Franche-Comté (UFC), Bosi, E, Choudhary, P, de Valk, H, Lablanche, S, Castaneda, J, de Portu, S, Da Silva, J, Re, R, Vorrink-de Groot, L, Shin, J, Kaufman, F, Cohen, O, Laurenzi, A, Caretto, A, Slatterly, D, Henderson-Wilson, M, Weisnagel, S, Dube, M, Julien, V, Trevisan, R, Lepore, G, Bellante, R, Hramiak, I, Spaic, T, Driscoll, M, Borot, S, Clergeot, A, Khiat, L, Hammond, P, Ray, S, Dinning, L, Tonolo, G, Manconi, A, Ledda, M, de Ranitz, W, Silvius, B, Wojtusciszyn, A, Farret, A, Vriesendorp, T, Immeker-de Jong, F, van der Linden, J, Brink, H, Alkemade, M, Schaepelynck-Belicar, P, Galie, S, Treglia, C, Benhamou, P, Haddouche, M, Hoogma, R, Leelarathna, L, Shaju, A, James, L, Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hospices Civils de Lyon (HCL), Université Joseph Fourier - Grenoble 1 (UJF)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA), Bosi, E., Choudhary, P., de Valk, H. W., Lablanche, S., Castaneda, J., de Portu, S., Da Silva, J., Re, R., Vorrink-de Groot, L., Shin, J., Kaufman, F. R., Cohen, O., Laurenzi, A., Caretto, A., Slatterly, D., Henderson-Wilson, M., Weisnagel, S. J., Dube, M. -C., Julien, V. -E., Trevisan, R., Lepore, G., Bellante, R., Hramiak, I., Spaic, T., Driscoll, M., Borot, S., Clergeot, A., Khiat, L., Hammond, P., Ray, S., Dinning, L., Tonolo, G., Manconi, A., Ledda, M. S., de Ranitz, W., Silvius, B., Wojtusciszyn, A., Farret, A., Vriesendorp, T., Immeker-de Jong, F., van der Linden, J., Brink, H. S., Alkemade, M., Schaepelynck-Belicar, P., Galie, S., Treglia, C., Benhamou, P. -Y., Haddouche, M., Hoogma, R., Leelarathna, L., Shaju, A., and James, L.

Subjects
Adult, Male, Insulin pump, Pediatrics, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, [SDV]Life Sciences [q-bio], Population, glucose, hemoglobin A1c, insulin, antidiabetic agent, 030209 endocrinology & metabolism, Low insulin, law.invention, 03 medical and health sciences, Insulin Infusion Systems, 0302 clinical medicine, Endocrinology, Randomized controlled trial, law, Internal Medicine, medicine, Humans, Hypoglycemic Agents, Insulin, 030212 general & internal medicine, education, ComputingMilieux_MISCELLANEOUS, education.field_of_study, Type 1 diabetes, Continuous glucose monitoring, business.industry, Middle Aged, medicine.disease, Hypoglycemia, 3. Good health, Diabetes Mellitus, Type 1, Hypoglycaemia unawareness, Female, Open label, business
Abstract

Background: Hypoglycaemia unawareness and severe hypoglycaemia can increase fear of hypoglycaemia and the risk of subsequent hypoglycaemic events. We aimed to assess the safety and efficacy of insulin pump therapy with integrated continuous glucose monitoring (CGM) and a suspend-before-low feature (Medtronic MiniMed 640G with SmartGuard) in hypoglycaemia-prone adults with type 1 diabetes. Methods: SMILE was an open-label randomised controlled trial done in people aged 24–75 years with type 1 diabetes for 10 years or longer, HbA1c values of 5·8–10·0% (40–86 mmol/mol), and at high risk of hypoglycaemia (recent severe hypoglycaemia or hypoglycaemia unawareness defined by a Clarke or Gold score ≥4). Participants were enrolled from 16 centres (eg, clinics, hospitals, or university medical centres) in Canada, France, Italy, the Netherlands, and the UK. After baseline run-in phase (2 weeks), participants were randomly assigned to the MiniMed 640G pump (continuous subcutaneous insulin infusion) with self-monitoring of blood glucose (control group) or to the MiniMed 640G system with the suspend-before-low feature enabled (intervention group), for 6 months. The study statistician analysing the data was masked to group assignment until final database lock; because of the nature of the intervention, participants and treating clinicians could not be masked to group assignment. The primary outcome was the mean number of sensor hypoglycaemic events, defined as 55 mg/dL (3·1 mmol/L) or lower, and was analysed on an intention-to-treat basis in all randomly assigned participants. This trial is registered with ClinicalTrials.gov, number NCT02733991, and is completed. Findings: Between Dec 7, 2016, and March 27, 2018, 153 participants with a mean age 48·2 [12·4] years were randomly assigned: 77 to the control group (mean age 47·4 [12·5] years) and 76 to the intervention group (mean age 49·0 [12·2] years). After 6 months, the intervention group had significantly fewer hypoglycaemic events per participant per week (1·1 [SD 1·2] vs 4·1 [3·4] mean events, model-based treatment effect −2·9 [95% CI −3·5 to −2·3]; p

Published
2019

49. Metformin and carotid intima‐media thickness in never‐smokers with type 1 diabetes: The REMOVAL trial.

Author

Timmons, Joseph G., Greenlaw, Nicola, Boyle, James G., Chaturvedi, Nish, Ford, Ian, Brouwers, Martijn C. G. J., Tillin, Therese, Hramiak, Irene, Hughes, Alun D., Jenkins, Alicia J., Klein, Barbara E. K., Klein, Ron, Ooi, Teik C., Rossing, Peter, Stehouwer, Coen D. A., Sattar, Naveed, Colhoun, Helen M., and Petrie, John R.

Subjects
CAROTID intima-media thickness, TYPE 1 diabetes, METFORMIN, DAPAGLIFLOZIN, CIGARETTE smoke
Abstract

Aim: To determine whether metformin's effects on carotid artery intima‐media thickness (cIMT) in type 1 diabetes differ according to smoking status. Methods: Regression model effect estimates for the effect of metformin versus placebo (double‐blind) on carotid IMT were calculated as a subgroup analysis of the REMOVAL trial. Results: In 428 randomized participants (227 never‐smokers, 201 ever‐smokers), averaged mean carotid IMT progression (per year) was reduced by metformin versus placebo in never‐smokers (−0.012 mm, 95% CI −0.021 to −0.002; p =.0137) but not in ever‐smokers (0.003 mm, 95% CI −0.008 to 0.014; p =.5767); and similarly in non‐current smokers (−0.008 mm, 95% CI −0.015 to −0.00001; p =.0497) but not in current smokers (0.013 mm, 95% CI −0.007 to 0.032; p =.1887). Three‐way interaction terms (treatment*time*smoking status) were significant for never versus ever smoking (p =.0373, prespecified) and non‐current versus current smoking (p =.0496, exploratory). Averaged maximal carotid IMT progression (per year) was reduced by metformin versus placebo in never‐smokers (−0.020 mm, 95% CI −0.034 to −0.006; p =.0067) but not in ever‐smokers (−0.006 mm, 95% CI −0.020 to 0.008; p =.4067), although this analysis was not supported by a significant three‐way interaction term. Conclusions: This subgroup analysis of the REMOVAL trial provides additional support for a potentially wider role of adjunct metformin therapy in cardiovascular risk management in type 1 diabetes, particularly for individuals who have never smoked cigarettes. [ABSTRACT FROM AUTHOR]

Published
2021
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50. Second-Generation Insulin Analogues - a Review of Recent Real-World Data and Forthcoming Head-to-Head Comparisons

Author

Mauricio Puente, Dídac, Hramiak, Irene, and Universitat Autònoma de Barcelona

Subjects
Insulin degludec, medicine.medical_specialty, Head to head, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, 030209 endocrinology & metabolism, Type 2 diabetes, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Diabetes mellitus, medicine, Insulin glargine 300, Disease management (health), Intensive care medicine, Endocrine and Autonomic Systems, Insulin glargine, business.industry, Insulin, Once-daily insulin, medicine.disease, Second-generation, business, Hypoglycaemia, Real world data, medicine.drug
Abstract

Altres ajuts: Editorial assistance was provided by Touch Medical Media and was funded by Sanofi. Insulin analogues play a key role in the effective management of type 2 diabetes. However, there are several behavioural barriers to appropriate early initiation of insulin therapy, despite compelling evidence supporting the benefits of this strategy in those patients for whom oral anti-diabetes agents provide insufficient control. The development of second-generation insulin analogues (insulin glargine 300 U/mL and insulin degludec) has provided physicians with agents that can provide comparable glycaemic control to first-generation insulin, but with a reduced risk of hypoglycaemia and modes of action suited to once-daily regimens. These characteristics may help overcome patient and physician concerns about early insulin use in disease management. To date, there have been no head-to-head comparisons of second-generation insulins: here we consider recent real-world evidence and the forthcoming direct comparison in the BRIGHT randomised controlled study, as presented at the recent 11 th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) 2018.

Published
2018

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