A Comparison of Exenatide and Insulin Glargine

Screening will be made to select eligible patients, then 44 patients receiving a stable dose of metformin (≥1500 mg daily) will be randomized (1:1) to receive exenatide or insulin glargine for 16 weeks. Exenatide will be administered twice daily by subcutaneous injection 30- 60 minutes before breakfast and dinner; the dose was 5 μg twice-daily for the first 4 weeks of treatment and 10 μg thereafter. Insulin glargine will be administered once daily at bedtime by subcutaneous injection. The dose of insulin glargine will initiate at ≥8 IU once-daily, and titrate based on a dosing algorithm targeting fasting blood glucose (FPG)<6.1 mmol/L. Titration is only allowed in first 4 weeks. At the end of the study, data will be collected and analyzed.

Inclusion criteria

• Provision of informed consent prior to any study specific procedures
• Type2 diabetic patients had been on stable, maximum tolerated doses of metformin (≧1500mg/d, ≧8 weeks)
• Male or female age ≧ 18 years and ≦70 years old
• HbA1c ≧7.0 and ≦10%
• BMI ≧ 24 kg/m2

Exclusion criteria

• Known or suspected allergy to trial products or related products.
• Impaired renal function defined as serum-creatinine ≥ 1.5 mg/dl (≥ 133 umol/l).
• Acute or chronic disease which may cause tissue hypoxia such as respiratory failure or shock.
• Abnormal liver function, alanine transaminase or aspartate aminotransferase ≥ 3 fold normal upper limit, Total bilirubin ≥ 2 normal upper limit, acute alcohol intoxication, alcoholism.
• Subjects has a clinically significant, active (or over the past 12 months) cardiovascular history (including a history of myocardial infarction (MI), arrhythmias or conduction delays on ECG, unstable angina, or decompensated heart failure (New York Heart Association-class Ⅲ and Ⅳ).
• Proliferative retinopathy or muscular oedema requiring acute treatment.
• Pregnant or positive pregnancy test at screening, nursing mother, or unwillingness to use adequate contraception (adequate contraceptive measures are sterilization, intrauterine device, oral contraceptives or barrier methods).
• Treatment with systemic corticosteroids within the past two months prior to screening.
• Type 1 diabetes mellitus.
• Receipt of any investigational drug within 1 month prior to this trial.