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1. Lower fasting blood glucose, glucose variability and nocturnal hypoglycaemia with glargine vs NPH basal insulin in subjects with Type 1 diabetes.

Author

Bolli GB, Songini M, Trovati M, Del Prato S, Ghirlanda G, Cordera R, Trevisan R, Riccardi G, and Noacco C

Subjects
Adolescent, Adult, Biomarkers blood, Blood Glucose Self-Monitoring, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 physiopathology, Female, Glycated Hemoglobin metabolism, Humans, Hypoglycemia blood, Hypoglycemia physiopathology, Hypoglycemic Agents administration & dosage, Insulin administration & dosage, Insulin adverse effects, Insulin Glargine, Insulin Lispro, Insulin, Isophane administration & dosage, Insulin, Long-Acting, Italy, Male, Middle Aged, Quality of Life, Treatment Outcome, Young Adult, Blood Glucose drug effects, Circadian Rhythm, Diabetes Mellitus, Type 1 drug therapy, Fasting blood, Hypoglycemia chemically induced, Hypoglycemic Agents adverse effects, Insulin analogs & derivatives, Insulin, Isophane adverse effects
Abstract

Background and Aims: To compare switching from NPH insulin (NPH) to insulin glargine (glargine) with continuing NPH for changes in fasting blood glucose (FBG) in patients with Type 1 diabetes on basal-bolus therapy with insulin lispro as bolus insulin. Secondary objectives included self-monitoring blood glucose, mean daily blood glucose (MDBG) and mean amplitude glucose excursion (MAGE) values alongside changes in HbA(1c) and safety profiles., Methods and Results: This was a 30-week, parallel, open-label, multicentre study. Seven-point profiles were used to calculate MDBG and MAGE. Hypoglycaemia and adverse events were recorded by participants. FBG improved significantly with both glargine (baseline-endpoint change: -28.0 mg/dL; 95% CI: -37.3, -18.7 mg/dL; p<0.001) and NPH (-9.8 mg/dL; 95% CI: -19.1, -0.5 mg/dL; p=0.0374). The improvement was significantly greater with glargine than NPH (mean difference: -18.2 mg/dL; 95% CI: -31.3, -5.2 mg/dL; p=0.0064). MDBG (-10.1 mg/dL; 95% CI: -18.1, -2.1 mg/dL; p=0.0126) and MAGE (-20.0 mg/dL; 95% CI: -34.5, -5.9 mg/dL; p=0.0056) decreased significantly with glargine, but not NPH although endpoint values were no different with the two insulins. Baseline to endpoint change in HbA(1c) was similar (-0.56 vs -0.56%) with no differences at endpoint. Overall hypoglycaemia was no different, but glargine reduced nocturnal hypoglycaemia ("serious episodes" with BG < 42 mg/dl, p=0.006) whereas NPH did not (p=0.123), although endpoint values were no different., Conclusion: Switching from NPH to glargine is well tolerated and results into lower FBG, and lower glucose variability while reducing nocturnal hypoglycaemia. These data provide a rationale for more aggressive titration to target with glargine in Type 1 diabetes.

Published
2009
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2. Carbohydrate requirement and insulin concentration during moderate exercise in type 1 diabetic patients.

Author

Francescato MP, Geat M, Fusi S, Stupar G, Noacco C, and Cattin L

Subjects
Adolescent, Adult, Blood Glucose metabolism, Carbon Dioxide metabolism, Diabetes Mellitus, Type 1 blood, Exercise Test, Fatty Acids, Nonesterified blood, Female, Humans, Hypoglycemic Agents therapeutic use, Insulin therapeutic use, Male, Middle Aged, Oxygen Consumption physiology, Diabetes Mellitus, Type 1 metabolism, Dietary Carbohydrates metabolism, Exercise physiology, Insulin blood
Abstract

The lack in control of insulin release combined with an inadequate carbohydrate (CHO) ingestion accounts for the occurrence of frequent metabolic unbalances during exercise in type 1 diabetic patients. The aim of the study was to quantify, in these patients, the CHO requirement to prevent hypoglycemia during moderate exercise performed at different time intervals after morning subcutaneous insulin injection. Twelve type 1 diabetic patients and 12 well-matched healthy subjects cycled 4 times for 1 hour at a constant workload. The rate of glucose oxidation was calculated continuously by indirect calorimetry throughout the exercise, while blood parameters were assessed periodically and orally given CHO were checked. CHO needed by the patients to prevent hypoglycemia decreased as the time elapsed from insulin administration increased, amounting to 0.63 +/- 0.30, 0.44 +/- 0.32, 0.28 +/- 0.24, and 0.14 +/- 0.18 g/kg after 1, 2.5, 4, and 5.5 hours, respectively. Total glucose requirement during moderate exercise (sum of alimentary and extracellular source) was correlated (r = 0.739, P <.001) to plasma insulin concentration, but not with fitness level. Time elapsed from last insulin dose is not a factor influencing the risk of hypoglycemia during exercise when a proportional, appropriate amount of CHO is ingested.

Published
2004
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3. Residual B cell activity and insulin requirements in insulin-dependent diabetic patients treated from the beginning with high doses of nicotinamide. A two-year follow-up.

Author

Taboga C, Tonutti L, and Noacco C

Subjects
Adult, B-Lymphocytes physiology, Diabetes Mellitus, Type 1 immunology, Female, Follow-Up Studies, Humans, Male, B-Lymphocytes drug effects, Diabetes Mellitus, Type 1 drug therapy, Insulin therapeutic use, Niacinamide administration & dosage
Abstract

Nicotinamide was shown to prevent damage and to stimulate B cell regeneration in experimental diabetes but in humans results are still controversial. To ascertain if long term nicotinamide treatment can induce and/or prolong remission of the disease, 21 type 1 (insulin-dependent) recently diagnosed subjects entered a controlled study and randomly divided in two groups comparable for age, genetic and immunologic patterns: group 1 (11 subjects) received insulin and nicotinamide (3 g/day for 1 year) and group 2 (10 subjects) insulin alone. Bimonthly insulin requirement and HbA1c, and every 6 months C-peptide response to glucagon were registered for 2 years. No significant difference was observed between the two groups in the monitored parameters, including rates of clinical remission, along this time period. In conclusion nicotinamide, when employed after the clinical onset of the disease, has no additional effect on natural history of newly diagnosed type 1 diabetes mellitus, besides results obtained by insulin alone.

Published
1994

4. Lower fasting blood glucose, glucose variability and nocturnal hypoglycaemia with glargine vs NPH basal insulin in subjects with Type 1 diabetes

Author

Gabriele Riccardi, Mariella Trovati, Renzo Cordera, R. Trevisan, M. Songini, Geremia B. Bolli, Giovanni Ghirlanda, C. Noacco, S. Del Prato, Bolli, G, Songini, M, Trovati, M, Del Prato, S, Ghirlanda, G, Cordera, R, Trevisan, R, Riccardi, G, Noacco, C, Bolli, Gb, De Prato, S, Riccardi, Gabriele, and Noacco, C.

Subjects
Blood Glucose, Male, type 1 diabetes, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Insulin, Isophane, Medicine (miscellaneous), Insulin Glargine, NPH insulin, Basal insulin, Insulin analogues, Glargine, Intensive therapy, Insulin, Basal insulin, Glargine, Insulin analogue, Nutrition and Dietetics, Insulin Lispro, Fasting, Middle Aged, Intensive therapy, Circadian Rhythm, Insulin, Long-Acting, Treatment Outcome, Italy, fasting blood glucose, Female, Cardiology and Cardiovascular Medicine, medicine.drug, Adult, medicine.medical_specialty, Adolescent, Young Adult, Internal medicine, Blood Glucose Self-Monitoring, Diabetes mellitus, medicine, Insulin lispro, Humans, Hypoglycemic Agents, Adverse effect, glucose variability, Glycated Hemoglobin, Type 1 diabetes, Insulin analogues, Insulin glargine, business.industry, medicine.disease, hypoglycemia, Endocrinology, Diabetes Mellitus, Type 1, Quality of Life, business, Biomarkers
Abstract

Background and aims: To compare switching from NPH insulin (NPH) to insulin glargine (glargine) with continuing NPH for changes in fasting blood glucose (FBG) in patients with Type 1 diabetes on basal-bolus therapy with insulin lispro as bolus insulin. Secondary objectives included self-monitoring blood glucose, mean daily blood glucose (MDBG) and mean amplitude glucose excursion (MAGE) values alongside changes in HbA1c and safety profiles. Methods and results: This was a 30-week, parallel, open-label, multicentre study. Seven-point profiles were used to calculate MDBG and MAGE. Hypoglycaemia and adverse events were recorded by participants. FBG improved significantly with both glargine (baseline-endpoint change: -28.0 mg/dL; 95% CI: -37.3, -18.7 mg/dL; p < 0.001) and NPH (-9.8 mg/dL; 95% CI: -19.1, -0.5 mg/dL; p = 0.0374). The improvement was significantly greater with glargine than NPH (mean difference: -18.2 mg/dL; 95% CI: -31.3, -5.2 mg/dL; p = 0.0064). MDBG (-10.1 mg/dL; 95% CI: -18.1, -2.1 mg/dL; p = 0.0126) and MAGE (-20.0 mg/dL; 95% CI: -34.5, -5.9 mg/dL; p = 0.0056) decreased significantly with glargine, but not NPH although endpoint values were no different with the two insulins. Baseline to endpoint change in HbA1c was similar (-0.56 vs -0.56%) with no differences at endpoint. Overall hypoglycaemia was no different, but glargine reduced nocturnal hypoglycaemia ("serious episodes" with BG < 42 mg/dl, p = 0.006) whereas NPH did not (p = 0.123), although endpoint values were no different. Conclusion: Switching from NPH to glargine is well tolerated and results into lower FBG, and lower glucose variability while reducing nocturnal hypoglycaemia. These data provide a rationale for more aggressive titration to target with glargine in Type 1 diabetes.

Published
2009

5. Quality of life and treatment satisfaction in adults with Type 1 diabetes: a comparison between continuous subcutaneous insulin infusion and multiple daily injections

Author

A. Nicolucci, A. Maione, M. Franciosi, R. Amoretti, E. Busetto, F. Capani, D. Bruttomesso, P. Di Bartolo, A. Girelli, F. Leonetti, L. Morviducci, P. Ponzi, E. Vitacolonna, L. V. Cassano, N. Tota, V. Cherubini, A. Iannilli A. Corsi, P. Ponzani, V. Montani, P. Di Berardino, M. Velussi, F. Giorgino, V. Gigantelli, G. Beltramello, A. Pianta, R. Trevisan, G. Lepore, G. Forlani, G. Marchesini, D. Crazzolara, M. Marchesi, E. Zarra, B. Agosti, G. Careddu, L. Tomaselli, R. Vigneri, M. Agrusta, V. Di Blasi, S. Tumini, M. T. Anzellotti, P. Ruggeri, P. Foglini, M. Rossana, A Murri, S. Toni, M. F. Reali, M. Nizzoli, S. Aquati, G. d’Annunzio, N. Minuto, L. Cataldi, C. Bordone, R. Iannarelli, F. Sciarretta, M. Tagliaferri, M. A. Lezzi, L. Sciangula, A. Ciucci, M. Bonomo, E. Meneghini, G. Mariani, P. Colapinto, G. Testori, P. Rampini, R. Bonfanti, F. Meschi, G. Galimberti, A. Laurenzi, A. Veronelli, C. Mauri, C. Tortul, A. M. Cernigoi, M. E. De Feo, M. Piscopo, G. Annuzzi, L. Bozzetto, A. Franzese, P. Buono, S. Turco, A. Turco, F. Prisco, D. Iafusco, M. Trovati, P. Massucco, S. Costa, M, V. Provenzano, L. Strazzera, G. Ridola, E. Torlone, M. Orsini Federici, A. Bertolotto, M. Aragona, F. Pellicano, V. Manicardi, M. Michelini, M. Parenti, A. C. Babini, P. Borboni, A. Di Flaviani, M. L. Manca Bitti, S. Piccinini, A. Clementi, C. Tubili, C. Suraci, S. Carletti, A. Moretti, M. Maiello, V. C. Iannucci, N. Sulli, B. Shashaj, D. Fava, F. Massimiani, P. Pozzilli, S. Manfrini, C. Landi, I. Tanganelli, G. Grassi, M. Tomelini, R. De Luca, L. Corgiat Mansin, R. Candido, E. Manca, L. Tonutti, C. Noacco, I. Franzetti, P. Marnini., Nicolucci, A., Maione, A., Franciosi, M., Amoretti, R., Busetto, E., Capani, F., Bruttomesso, D., Di Bartolo, P., Girelli, A., Leonetti, F., Morviducci, L., Ponzi, P., Vitacolonna, E., Cassano, L. V., Tota, N., Cherubini, V., Corsi, A. Iannilli A., Ponzani, P., Montani, V., Di Berardino, P., Velussi, M., Giorgino, F., Gigantelli, V., Beltramello, G., Pianta, A., Trevisan, R., Lepore, G., Forlani, G., Marchesini, G., Crazzolara, D., Marchesi, M., Zarra, E., Agosti, B., Careddu, G., Tomaselli, L., Vigneri, R., Agrusta, M., Di Blasi, V., Tumini, S., Anzellotti, M. T., Ruggeri, P., Foglini, P., Rossana, M., Murri, A, Toni, S., Reali, M. F., Nizzoli, M., Aquati, S., D’Annunzio, G., Minuto, N., Cataldi, L., Bordone, C., Iannarelli, R., Sciarretta, F., Tagliaferri, M., Lezzi, M. A., Sciangula, L., Ciucci, A., Bonomo, M., Meneghini, E., Mariani, G., Colapinto, P., Testori, G., Rampini, P., Bonfanti, R., Meschi, F., Galimberti, G., Laurenzi, A., Veronelli, A., Mauri, C., Tortul, C., Cernigoi, A. M., De Feo, M. E., Piscopo, M., Annuzzi, G., Bozzetto, L., Franzese, A., Buono, P., Turco, S., Turco, A., Prisco, F., Iafusco, D., Trovati, M., Massucco, P., Costa, S., M, Provenzano, V., Strazzera, L., Ridola, G., Torlone, E., Orsini Federici, M., Bertolotto, A., Aragona, M., Pellicano, F., Manicardi, V., Michelini, M., Parenti, M., Babini, A. C., Borboni, P., Di Flaviani, A., Manca Bitti, M. L., Piccinini, S., Clementi, A., Tubili, C., Suraci, C., Carletti, S., Moretti, A., Maiello, M., Iannucci, V. C., Sulli, N., Shashaj, B., Fava, D., Massimiani, F., Pozzilli, P., Manfrini, S., Landi, C., Tanganelli, I., Grassi, G., Tomelini, M., De Luca, R., Corgiat Mansin, L., Candido, R., Manca, E., Tonutti, L., Noacco, C., Franzetti, I., and Marnini., P.

Subjects
multiple daily injections, Insulin pump, Adult, Male, medicine.medical_specialty, Continuous subcutaneous insulin infusion, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Injections, Subcutaneous, Insulin Glargine, Endocrinology, Patient satisfaction, Insulin Infusion Systems, Quality of life, Internal medicine, Diabetes mellitus, Internal Medicine, medicine, Humans, Hypoglycemic Agents, Insulin, Multiple daily injection, continuous subcutaneous insulin infusion, quality of life, questionnaires, type 1 diabetes, Type 1 diabetes, Questionnaire, Insulin glargine, business.industry, Middle Aged, medicine.disease, Obesity, Surgery, Insulin, Long-Acting, Diabetes Mellitus, Type 1, Patient Satisfaction, Quality of Life, Female, business, Epidemiologic Methods, medicine.drug
Abstract

Aims The aim of this case–control study was to compare quality of life (QoL) and treatment satisfaction in adults with Type 1 diabetes (T1DM) treated with either continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI). Methods Consecutive patients aged between 18 and 55 years, and attending diabetes clinics for a routine visit, completed the Diabetes-Specific Quality-of-Life Scale (DSQOLS), the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and the SF-36 Health Survey (SF-36). Case (CSII) and control subjects (MDI) were recruited in a 1 : 2 ratio. Results Overall, 1341 individuals were enrolled by 62 diabetes clinics; 481 were cases and 860 control subjects. Cases had a longer diabetes duration and were more likely to have eye and renal complications. Age, school education, occupation and HbA 1c were similar. Of control subjects, 90% followed glargine-based MDI regimens and 10% used NPH-based MDI regimens. On multivariate analysis, after adjusting for socioeconomic and clinical characteristics, scores in the following areas of the DSQOLS were higher in cases than control subjects: diet restrictions ( β = 5.96; P < 0.0001), daily hassles ( β = 3.57; P = 0.01) and fears about hypoglycaemia ( β = 3.88; P = 0.006). Treatment with CSII was also associated with a markedly higher DTSQ score ( β = 4.13; P < 0.0001) compared with MDI. Results were similar when CSII was compared separately with glargine- or NPH-based MDI regimens. Conclusions This large, non-randomized, case–control study suggests quality of life gains deriving from greater lifestyle flexibility, less fear of hypoglycaemia, and higher treatment satisfaction, when CSII is compared with either glargine-based or NPH-based MDI regimens. Diabet. Med. 25, 213–220 (2008)

Published
2008

6. Residual B cell activity and insulin requirements in insulin-dependent diabetic patients treated from the beginning with high doses of nicotinamide. A two-year follow-up

Author

C, Taboga, L, Tonutti, and C, Noacco

Subjects
Adult, Male, Niacinamide, B-Lymphocytes, Diabetes Mellitus, Type 1, Humans, Insulin, Female, Follow-Up Studies
Abstract

Nicotinamide was shown to prevent damage and to stimulate B cell regeneration in experimental diabetes but in humans results are still controversial. To ascertain if long term nicotinamide treatment can induce and/or prolong remission of the disease, 21 type 1 (insulin-dependent) recently diagnosed subjects entered a controlled study and randomly divided in two groups comparable for age, genetic and immunologic patterns: group 1 (11 subjects) received insulin and nicotinamide (3 g/day for 1 year) and group 2 (10 subjects) insulin alone. Bimonthly insulin requirement and HbA1c, and every 6 months C-peptide response to glucagon were registered for 2 years. No significant difference was observed between the two groups in the monitored parameters, including rates of clinical remission, along this time period. In conclusion nicotinamide, when employed after the clinical onset of the disease, has no additional effect on natural history of newly diagnosed type 1 diabetes mellitus, besides results obtained by insulin alone.

Published
1994

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