A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: exenatide once weekly; exenatide twice daily
Intervention description: 2.0mg subcutaneous injection, once a week; 5mcg subcutaneous injection twice a day (4 weeks), 10mcg subcutaneous injection twice a day (22 weeks)
Intervention MeSH terms: Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 691.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: diabetes; exenatide; once weekly; Byetta; Amylin; Lilly

Summary:

      Previous studies have suggested that a once-weekly formulation of exenatide may provide
      sustained glycemic control. These previous studies of exenatide once weekly have been
      conducted in non-Asian populations, so this study has been developed to support the local
      regulatory requirements of China, Korea, Japan, India, and Taiwan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been diagnosed with type 2 diabetes.

          -  Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11.0%
             inclusive.

          -  Have a body mass index (BMI) of >21 kg/m2 and <35 kg/m2, inclusive.

          -  Have a history of stable body weight (not varying by >5% for at least 90 days prior to
             study start).

          -  Have been treated with a stable dose regimen of Met, SU, TZD, Met plus SU, Met plus
             TZD, or SU plus TZD for at least 90 days prior to study start.

        Exclusion Criteria:

          -  Have any contraindication for the OAD(s) that they use.

          -  Have a known allergy or hypersensitivity to exenatide BID, exenatide QW, or excipients
             contained in these agents.

          -  Have received chronic >14 consecutive days) systemic glucocorticoid therapy by oral,
             intravenous (IV), or intramuscular (IM) route or intra-articular steroid injection
             within 4 weeks prior to study start or are regularly treated with potent, inhaled
             steroids that are known to have a high rate of systemic absorption.

          -  Have been treated with drugs that promote weight loss (for example, GLP-1 analogue,
             orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications)
             within 90 days of study start.

          -  Have been treated for >2 weeks with any of the following excluded medications within
             90 days prior to study start:

               -  Insulin

               -  Dipeptidyl peptidase (DPP)-4 inhibitors (for example, sitagliptin or
                  vildagliptin)

               -  Pramlintide acetate

               -  Drugs that directly affect gastrointestinal motility, including, but not limited
                  to: Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide
                  antibiotics.

          -  Have had prior exposure to exenatide

          -  Have previously completed or withdrawn from this study or any other study
             investigating exenatide BID or QW.

          -  Have received treatment within the last 30 days with a drug that has not received
             regulatory approval for any indication at the time of study entry.

          -  Are currently enrolled in any other clinical study.