A Study to Examine the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension
Condition: Type 2 Diabetes
Intervention: exenatide once weekly; exenatide once monthly suspension; exenatide once monthly suspension; exenatide once monthly suspension
Intervention description: subcutaneous injection, 2 mg, once a week; subcutaneous injection, low dose, once a month; subcutaneous injection, medium dose, once a month; subcutaneous injection, high dose, once a month
Intervention MeSH terms: Exenatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Exenatide; Amylin; Lilly; Byetta; Exenatide Once Weekly

Summary:

      The purpose of Study BCB111 is to collect efficacy, pharmacokinetic, pharmacodynamic, safety,
      and tolerability data in patients with type 2 diabetes to assess the feasibility of once
      monthly dosing of the exenatide suspension formulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is at least 18 years old at study start

          -  Has been diagnosed with type 2 diabetes mellitus

          -  Has HbA1c of 7.1% to 11.0%, inclusive, at study start

          -  Has been treated with diet and exercise alone or with a stable regimen of metformin,
             pioglitazone, or a combination of metformin and pioglitazone, for a minimum of 2
             months prior to study start

          -  Either is not treated with or has been on a stable treatment regimen with any of the
             following medications for a minimum of 2 months prior to study start: hormone
             replacement therapy (female subjects); antihypertensive agents; thyroid replacement
             therapy; or antidepressant agents

        Exclusion Criteria:

          -  Clinically significant medical condition that could potentially affect study
             participation including:

          -  Acute or chronic pancreatitis

          -  Personal or family history of medullary thyroid carcinoma or multiple endocrine
             neoplasia (MEN) type 2

          -  Active cardiovascular disease within 3 months of study start

          -  Underlying hepatic or renal disease

          -  Inflammatory bowel disease, or other severe gastrointestinal diseases (particularly
             those that may affect gastric emptying, such as gastroparesis, pyloric stenosis, and
             metabolic surgery)

          -  Has had > 2 episodes of major hypoglycemia in the preceding 6 months before study
             start

          -  Has received any investigational drug within 30 days (or 5 half-lives of the
             investigational drug, whichever is greater) prior to study start

          -  Has been treated, is currently being treated, or is expected to require or undergo
             treatment with any of the following treatment excluded medications:

               -  Any exposure to exenatide (BYETTA®, exenatide once weekly, or exenatide
                  suspension), liraglutide (Victoza®), or any GLP-1 receptor agonist

               -  Any DPP-IV inhibitor, sulfonylurea (SU), or rosiglitazone (Avandia®) within 3
                  months prior to study start

               -  Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®)
                  within 30 days prior to study start

               -  Insulin within 2 weeks prior to study start, or for more than 1 week within 3
                  months prior to study start

               -  Systemic corticosteroids by oral, intravenous, intra-articular, or intramuscular
                  route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known
                  to have a high rate of systemic absorption

               -  Prescription or over-the-counter weight loss medications within 3 months prior to
                  study start