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