Type 2 Diabetic Patients Clinical Trial
Official title:
Impact of Insulin (I.)Glargine Compared to NPH I. and to I. Detemir in Combination With Metformin on Prandial ß-cell Function and Overall Metabolic Control in Type 2 Diabetic Patients With Insufficient Metabolic Control During OAD Treatment
The aim of the study is to show that treatment with Glargine will lead to an improvement in
beta cell function especially within times of maximal beta cell stress occurring after a
meal. For this reason three different standardized test meals (breakfast, lunch, dinner)
will be performed and the postprandial secretion of intact proinsulin levels will be
measured. These measurements will be performed with patients treated in combination with
metformin and insulin glargine versus metformin plus NPH insulin (within the core study) and
if significant difference is observed, with a third treatment arm with metformin plus
insulin detemir.
Hypothesis is that the area under the curve (AUC) intact proinsulin levels within 2 hours
after test meal dinner of metformin plus insulin glargin differs from AUC intact proinsulin
levels of metformin plus NPH insulin.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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