Type 1 Diabetes Mellitus Clinical Trial
Official title:
A Single-center, Randomized, Double-blind, 3-period Cross-over Trial to Compare the Effect of Insulin Glulisine, Insulin Lispro and Unmodified Human Insulin on the Endogenous Glucose Production in Type 1 Diabetic Patients.
The primary objective of the study was to compare the effect of insulin glulisine, insulin
lispro and unmodified human insulin on endogenous glucose production during euglycemic
glucose clamps using stable labeled glucose in type 1 diabetic subjects.
The secondary objectives of the study were to assess:
- the effect of insulin glulisine, insulin lispro and unmodified human insulin on plasma
nonesterified free fatty acids (NEFA) and glycerol levels
- the effect of insulin glulisine, insulin lispro and unmodified human insulin on plasma
lactate levels
- the safety and tolerability of insulin glulisine in comparison to insulin lispro and
unmodified human insulin.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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