Overview

Beta-Cell Function of Insulin Glargine Compared to Neutral Protamine Hagedorn (NPH) Insuline and to Insulin Detemir in Combination With Metformin

Status:
Completed

Trial end date:
2009-03-01

Target enrollment:

Participant gender:

Summary

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.

Phase:

Phase 4

Details

Lead Sponsor:

ikfe-CRO GmbH

Collaborator:

IKFE Institute for Clinical Research and Development

Treatments:

Insulin
Insulin Detemir
Insulin Glargine
Insulin, Globin Zinc
Insulin, Isophane
Isophane insulin, beef
Isophane Insulin, Human
Metformin