Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Exenatide (AC2993); Insulin glargine
Intervention description: subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 22 weeks; subcutaneous injection, once daily; forced titration to target blood glucose level
Intervention MeSH terms: Insulin Glargine; Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 551.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Diabetes; Insulin glargine; comparator; Amylin; Lilly

Summary:

      This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial
      to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as
      measured by hemoglobin A1c (HbA1c).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients have been treated with a stable dose of one of the following for at least 3
             months prior to screening: 1. 1500 to 2550 mg/day immediate-release metformin (or 1500
             to 2000 mg/day extended-release metformin) and at least an optimally effective dose of
             a sulfonylurea, or 2. a fixed-dose sulfonylurea/metformin combination therapy with the
             same sulfonylurea and metformin requirements as for the individual components.

          -  HbA1c between 7.0% and 10.0%, inclusive.

          -  History of stable body weight (not varying by >10% for at least three months prior to
             screening).

          -  Female patients are not breastfeeding, and female patients of childbearing potential
             (not surgically sterilized and between menarche and 1-year postmenopause)

        Exclusion Criteria:

          -  Patients are investigator site personnel directly affiliated with the study, or are
             immediate family of investigator site personnel directly affiliated with the study.

          -  Patients are employed by Lilly or Amylin.

          -  Patients have participated in this study previously or any other study using AC2993 or
             GLP-1 analogs.

          -  Patients have participated in an interventional medical, surgical, or pharmaceutical
             study within 30 days prior to screening. This criterion includes drugs that have not
             received regulatory approval for any indication at the time of study entry.

          -  Patients have had greater than three episodes of severe hypoglycemia within 6 months
             prior to screening.

          -  Patients are undergoing therapy for a malignancy, other than basal cell or squamous
             cell skin cancer.

          -  Patients have cardiac disease that is Class III or IV, according to the New York Heart
             Association criteria.

          -  Patients have a known allergy or hypersensitivity to insulin glargine, AC2993, or
             excipients contained in these agents.

          -  Patients have characteristics contraindicating metformin or sulfonylurea use,
             according to product-specific label, in the opinion of the investigator.

          -  Patients have a history of renal transplantation or are currently receiving renal
             dialysis or have serum creatinine >=1.5 mg/dL for males and >=1.3 mg/dL for females.

          -  Patients have obvious clinical signs or symptoms of liver disease, acute or chronic
             hepatitis, or alanine aminotransferase/serum glutamicpyruvic transaminase greater than
             three times the upper limit of the reference range.

          -  Patients have known hemoglobinopathy or chronic anemia.

          -  Patients are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid
             therapy (excluding topical and inhaled preparations) or have received such therapy
             within 2 weeks immediately prior to screening.

          -  Patients have used any prescription drug to promote weight loss within 3 months prior
             to screening.

          -  Patients have any other condition (including known drug or alcohol abuse or
             psychiatric disorder) that precludes them from following and completing the protocol,
             in the opinion of the investigator.

          -  Patients fail to satisfy the investigator of suitability to participate for any other
             reason.