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

AstraZeneca

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: exenatide and placebo

Drug: exenatide and sitagliptin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00870194

H8O-CR-GWDK

Details and patient eligibility

About

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.

Enrollment

255 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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Have previously completed or withdrawn from this study or any other study investigating exenatide.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