Status:
COMPLETED
Beta-Cell Function of Insulin Glargine Compared to Neutral Protamine Hagedorn (NPH) Insuline and to Insulin Detemir in Combination With Metformin
Lead Sponsor:
ikfe-CRO GmbH
Collaborating Sponsors:
IKFE Institute for Clinical Research and Development
Conditions:
Type 2 Diabetic Patients
Insufficient Metabolic Control
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
Brief 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 reas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00941148
Start Date
April 1 2008
End Date
March 1 2009
Last Update
July 17 2009
Active Locations (1)
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1
ikfe GmbH, Clinic Department
Mainz, RLP, Germany, 55116