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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study investigated a 4-week adjunctive therapy of either a GLP-1 analog (exenatide), or a DPP-4 inhibitor (sitagliptin), given to a basal insulin analog (insulin glargine), and their effect on blood glucose control, versus insulin glargine alone as active comparator in type 2 diabetes.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Profil Institut für Stoffwechselforschung GmbH
• Collaborator: Sanofi
• Treatments: Exenatide; Insulin; Insulin Glargine; Insulin, Globin Zinc; Metformin; Sitagliptin Phosphate

Criteria

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