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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 202

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:
o100 mg/day sitagliptin and
oGreater than or equal to 1500 mg/day metformin, or maximum tolerated dose (extendedrelease or immediate-release).
-Have inadequate glycemic control as evidenced by an HbA1c between 7.1% and 9%, inclusive.
-Have a body mass index (BMI) greater than or equal to 20 kg/m2 and less than 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-Have previously completed or withdrawn from this study or any other study investigating exenatide.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:
oThiazolidinediones (TZD) within 3 months of screening.
oSulfonylurea (SU) within 3 months of screening.
oDipeptidyl peptidase-4 [DPP-4] inhibitors, with the exception of sitagliptin, within 3 months of screening.
oMeglitinide derivatives (for example, repaglinide or nateglinide) within 3 months of screening.
oAlpha-glucosidase inhibitors (for example, miglitol or acarbose) within 3 months of screening.
oExogenous insulin within the 3 months prior to screening.
oDrugs that directly affect gastrointestinal motility, including, but not limited to: metoclopramide, cisapride, and chronic macrolide antibiotics.
oSystemic 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.
oAny other oral antidiabetic (OAD) agent, other than sitagliptin or metformin, within 3 months prior to screening.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Test hypothesis that switching to exenatide & metformin is non-inferior to adding exenatide to sitagliptin & metformin, as measured by a change in HbA1c from baseline to endpoint, in patients with type 2 diabetes experiencing inadequate glycemic controlTimepoint: 20 weeks

Secondary Outcome Measures

Name	Time	Method
To compare treatment arms in terms of 7-point self-monitored blood glucose (SMBG) profiles and mean blood glucose measurement based on 7-point SMBGTimepoint: 20 weeks;To compare treatment arms in terms of change from baseline to endpoint in body weightTimepoint: 20 weeks;To compare treatment arms in terms of change from baseline to endpoint in fasting serum glucoseTimepoint: 20 weeks;To compare treatment arms in terms of change from baseline to endpoint in serum lipidsTimepoint: 20 weeks;To compare treatment arms in terms of change from baseline to endpoint in waist circumference and waist-to-hip ratioTimepoint: 20 weeks;To compare treatment arms in terms of proportion of patients achieving HbA1c &#8804;7.0%, <7.0% and &#8804;6.5% at endpointTimepoint: 20 Weeks;To compare treatment arms in terms of safety and tolerabilityTimepoint: 20 weeks

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