A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: exenatide and sitagliptin; exenatide and placebo
Intervention description: exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; sitagliptin-100mg tablet orally once a day; exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; placebo-tablet orally once a day
Intervention MeSH terms: Sitagliptin Phosphate; Exenatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 255.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: diabetes; exenatide; Byetta; sitagliptin; Januvia; Amylin; Lilly

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.
    

Eligibility 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          -  Have previously completed or withdrawn from this study or any other study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.