Glargine 300 more effective than glargine 100 currently available…
Two single-dose studies were conducted in Japan and Europe to compare the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of new insulin glargine 300 U/ml (Gla-300) and insulin glargine 100 U/ml (Gla-100) in people with type 1 diabetes mellitus.
In two double-blind, randomized, crossover studies, 18 Japanese participants (aged 20-65 years) and 24 European participants (aged 18-65 years) with glycated hemoglobin levels ≤9.0% (≤75 mmol/mol) received single subcutaneous doses of Gla-300, 0.4, 0.6 and 0.9 U/kg (0.9 U/kg in the European study only), and Gla-100, 0.4 U/kg. A 36-h euglycemic clamp procedure was performed after each dosing.
The serum insulin glargine concentration (INS) and glucose infusion rate (GIR) developed more gradually into more constant and prolonged profiles with Gla-300 than with Gla-100. In support of this, the times to 50% of glargine exposure and insulin activity were longer for all Gla-300 doses than for Gla-100 during the 36-h clamp period, indicating a more evenly distributed exposure and metabolic effect beyond 24 h. Exposure to insulin glargine and glucose utilization were lower with the 0.4 and 0.6 U/ml Gla-300 doses in both studies compared with the 0.4 U/ml Gla-100 dose. Glucose-lowering activity was detected for up to 36 h with all doses of Gla-300.
The researchers concluded that the single-dose injections of Gla-300 present more constant and prolonged PK and PD profiles compared with Gla-100, maintaining blood glucose control for up to 36 h in euglycemic clamp settings in Japanese and European participants with type 1 diabetes.
- Researchers studied the effectiveness of new insulin glargine 300 U/mL (Gla-300) vs insulin glargine 100 U/mL (Gla-100) in patients with type 1 diabetes. In two small double-blind, randomized, crossover studies, insulin glargine concentration and glucose infusion rates were more constant and prolonged with Gla-300. Dose activity was detected for up to 36 hours with Gla-300.
- Single-dose injections of Gla-300 produced more constant and prolonged effects than Gla-100.
Diabetes Obes Metab 2014 Dec 22;[EPub Ahead of Print], M Shiramoto, Single-Dose New Insulin Glargine 300 U/ml Provides Prolonged, Stable Glycaemic Control in Japanese and European People With Type 1 Diabetes