Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: exenatide once weekly; insulin detemir
Intervention description: subcutaneous injection, 2mg, once a week; subcutaneous injection, with dosage titrated according to the determir label and published titration schedule, once or twice a day
Intervention MeSH terms: Exenatide; Insulin Detemir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 222.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes; exenatide once weekly; Byetta; insulin detemir; Levemir; Amylin; Lilly

Summary:

      The purpose of this study is to compare the effects of exenatide once weekly (QW) and insulin
      detemir with respect to glycemic control, body weight, lipids, safety, tolerability, and
      patient reported outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have suboptimal glycaemic control as evidenced by an HbA1c 7.1% to 10.0%, inclusive

          -  Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive

          -  Are receiving metformin at a stable dose (consistent with country specific
             requirements) of a minimum of 1000mg for at least 3 months prior to start start OR are
             receiving metformin at a minimum dose (consistent with country specific requirements)
             of 1000mg and sulphonylurea (as separate medications not as a fixed dose combination)
             at stable doses for 3 months prior to study start

        Exclusion Criteria:

          -  Have any contraindication for the OAD that they have been using

          -  Have a known allergy or hypersensitivity to insulin detemir, exenatide or excipients
             contained in these agents

          -  Have been treated within 4 weeks of screening with systemic glucocorticoid therapy by
             oral, intravenous (IV) or intramuscular (IM) route, or are regularly treated with
             potent, inhaled intranasal steroids that are known to have a high rate of systemic
             absorption. Exceptions to this criterion include patients who are receiving
             glucocorticoid therapy for corticotropic hypopituitary deficiency (e.g. Addison
             disease)

          -  Have been treated with drugs that promote weight loss, within 3 months of screening

          -  Have been treated for longer than 2 weeks with any of the following excluded
             medications within 3 months prior to screening: insulin, alpha-glucosidase, Byetta®
             (exenatide BID formulation), thiazolidinediones (TZD), dipeptidyl peptidase (DPP)-4
             inhibitors

          -  Have previously completed or withdrawn from this study or any other study
             investigating exenatide 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, or discontinued within the last 30 days from, a clinical
             trial involving an off-label use of an investigational drug or device (other than the
             study drug/device used in this study), or concurrently enrolled in any other type of
             medical research judged not to be scientifically or medically compatible with this
             study