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

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