Adjunctive Therapy of Exenatide or Sitagliptin to Insulin Glargine in Type 2 Diabetes

Inclusion Criteria:

• male or female subjects aged between 35 and 70 years, inclusive
• type 2 diabetes with duration >6 months and <10 years
• for at least 3 months: treatment solely with a long- or intermediate-acting insulin formulation (insulin glargine, insulin detemir, or NPH insulin) with or without a stable dose of metformin or treatment solely with a stable dose of metformin or combination of stable doses of metformin plus sulfonylureas
• HbA1c >=7.0% and <=10.0%
• if treated with antihypertensive or lipid lowering agents, the treatment regimen had to be stable during 3 months prior to study start
• written informed consent

Exclusion Criteria:

• history or presence of cancer or any clinically relevant diseases
• chronic heart failure NYHA class III or IV, unstable angina pectoris or myocardial infarction within the previous 6 months
• recurrent hypoglycemia
• abnormal lab tests at screening (ALAT and/or ASAT >=3 times ULN), creatinine >1.6 mg/dL in males and >1.4 mg/dL in females
• clinically relevant ECG findings at screening
• treatment with a rapid-acting insulin or with a mixed insulin formulation during the previous 3 months
• treatment with any other OHA than metformin or metformin plus sulfonylureas during the previous 3 months
• any systemic or topical treatment with drugs known to influence glucose metabolism