A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether ceasing sitagliptin and switching to exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in those patients with type 2 diabetes who are experiencing inadequate glycemic control with a combination of sitagliptin and metformin.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Eli Lilly and Company
• Treatments: Exenatide; Metformin; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• Present with type 2 diabetes

• Patients have been treated with a stable dose of the following for at least 3 months prior to screening:

• 100 mg/day sitagliptin and

• ≥1500 mg/day metformin, or maximum tolerated dose (extended release or immediate-release).

• Have inadequate glycemic control as evidenced by an HbA1c between 7.1% and 9%, inclusive.

• Have a body mass index (BMI) ≥20 kg/m2 and <45 kg/m2

Exclusion Criteria:

• Are currently enrolled in, or discontinued within the last 30 days (or longer, if local guidelines require) from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.

• Have previously completed or withdrawn from this study or any other study investigating exenatide.

• Have a known allergy or hypersensitivity to exenatide, sitagliptin or excipients contained in exenatide or sitagliptin.

• Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 1 month of screening.

• Are currently treated with any of the following excluded medications:

• Thiazolidinediones (TZD) within 3 months of screening.

• Sulfonylurea (SU) within 3 months of screening.

• Dipeptidyl peptidase-4 [DPP-4] inhibitors, with the exception of sitagliptin, within 3 months of screening.

• Meglitinide derivatives (for example, repaglinide or nateglinide) within 3 months of screening.

• Alpha-glucosidase inhibitors (for example, miglitol or acarbose) within 3 months of screening.

• Exogenous insulin within the 3 months prior to screening.

• Drugs that directly affect gastrointestinal motility, including, but not limited to: metoclopramide, cisapride, and chronic macrolide antibiotics.

• Systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous (IV), or intramuscular (IM) route used regularly (for longer than 1 month) or used within 1 month immediately prior to screening.

• Any other oral antidiabetic (OAD) agent, other than sitagliptin or metformin, within 3 months prior to screening.