Trial | NCT00941148  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
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.
Study Started
Apr 30
2008
Primary Completion
Mar 31
2009
Study Completion
Mar 31
2009
Last Update
Jul 17
2009
Estimate

Drug Insulin Glargin

Drug NPH insulin

Drug Insulin detemir

Drug metformin

metformin (2000 mg/day)

Insulin glargine Active Comparator

Insulin glargine, dose individually adapted to reach treatment goal (FBG < 100 mg/dL)

NPH Insulin Active Comparator

NPH Insulin, dose individually adapted to reach treatment goal (FBG < 100 mg/dL)

Insulin detemir Active Comparator

Insulin detemir, dose individually adapted to reach treatment goal (FBG < 100 mg/dL)

Criteria 

Inclusion Criteria:

Type 2 Diabetes mellitus according to the ADA criteria
HbA1c between 6.5% and 8.5%
Individually optimized combination therapy with metformin in combination with sulfonylurea in a stable dosage within the last 3 months
Age between 40 and 75 years
Fasting intact proinsulin level > 7 pmol/Land < 20 pmol/Lat screening

Exclusion Criteria:

Type 1 Diabetes mellitus
Pre-Treatment with insulin within the last 3 months prior to screening
Pre-Treatment with PPARy-agonists (glitazones) within the last 3 months prior to screening
Major micro- or macrovascular complications as judged by the investigator
BMI > 40 kg/m²
Hypokalemia (K < 3.5 mmol /L)
History of drug or alcohol abuse
Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
History of severe or multiple allergies
Treatment with any other investigational drug within 3 months prior to screening
Progressive fatal disease
History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.3 mg/dL in women and > 1.7 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator
Pregnancy or breast feeding
Sexually active women of childbearing potential not actively and consistently practicing birth control by using a medically accepted device or therapy
No Results Posted