Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: exenatide once weekly; liraglutide
Intervention description: subcutaneous injection, 2mg, once weekly; subcutaneous injection, forced titration to 1.8mg, once daily
Intervention MeSH terms: Liraglutide; Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 912.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes; exenatide once weekly; Byetta; liraglutide; Victoza; Amylin; Lilly

Summary:

      No head to head comparisons between exenatide once weekly and liraglutide have been
      performed. Therefore, the purpose of this study is to compare exenatide once weekly to
      once-daily liraglutide with regard to HbA1c, body weight, subject-reported outcomes, and
      other clinical benefits. The study includes a 26-week treatment period and a safety follow-up
      visit 10 weeks after the final study drug dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes

          -  Have suboptimal glycemic control as evidenced by an HbA1c measurement at study start
             7.1% and 11.0%, inclusive

          -  Have a body mass index (BMI) ≤45 kg/m^2

          -  Have been treated with lifestyle modification (diet and exercise) and with one of the
             following single oral antidiabetic agents (OADs) or combinations of OADs administered
             at maximum tolerated dose:

               -  metformin

               -  SU

               -  metformin plus an SU

               -  metformin plus pioglitazone

        Exclusion Criteria:

          -  Have any contraindication, allergy, or hypersensitivity for the study drug (exenatide
             once weekly or liraglutide), exenatide twice daily, the OAD(s) being used, or the
             excipients contained in these agents

          -  If taking metformin and have a contraindication to metformin use

          -  Have been treated within 8 weeks of study start with systemic glucocorticoid therapy
             by oral, intravenous, intra-articular, or intramuscular route

          -  Have been treated with drugs that promote weight loss (e.g., Xenical® [orlistat],
             Meridia® [sibutramine], Acomplia® [rimonabant], Acutrim® [phenylpropanolamine], or
             similar over-the-counter medications) within 3 months of study start

          -  Have taken any of the following excluded medications for more than 1 week within the 3
             months prior to study start, or have taken any of the following excluded medications
             within 1 month prior to study start:

               -  Insulin

               -  Alpha-glucosidase inhibitors (e.g., Glyser® [miglitol] or Precose® [acarbose])

               -  Meglitinides (e.g., Prandin® [repaglinide] or Starlix® [nateglinide])

               -  Avandia® (rosiglitazone)

               -  Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia™ [sitagliptin], Galvus®
                  [vildagliptin], Onglyza™ [saxagliptin])

               -  Symlin® (pramlintide acetate)

          -  Have donated blood within 30 days prior to study start or have had a blood transfusion
             or severe blood loss within 3 months prior to study start

          -  Have at any time, including a clinical trial, taken exenatide once weekly, exenatide
             twice daily, liraglutide, or any other GLP-1 receptor agonist or GLP-1 analog

          -  Are currently enrolled in, or discontinued within the last 3 months or longer if
             required by local guidelines, from a clinical trial involving 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 been screen-failed from this study for any reason

          -  If a subject discontinues metformin, sulfonylurea, or pioglitazone prior to screening,
             the subject can be included if they discontinued the medication (whether alone or as
             component of combined medication) according to a specific schedule.