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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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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