Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: exenatide; biphasic insulin aspart
Intervention description: subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks; subcutaneous injection, twice daily; titration to target blood glucose level
Intervention MeSH terms: Insulin Aspart; Exenatide; Biphasic Insulins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 505.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: diabetes; exendin; Amylin; Lilly; insulin aspart

Summary:

      This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect
      of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as
      measured by hemoglobin A1c (HbA1c).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients have been treated with a stable dose of the following for at least 3 months
             prior to screening: 1. >=1500 mg/day immediate-release metformin or extended-release
             metformin and at least an optimally effective dose for brand of 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 11.0%, inclusive.

          -  Patients have a body mass index >25kg/m2 and <40 kg/m2.

          -  Female patients are not breastfeeding, and female patients of childbearing potential
             test negative for pregnancy, do not intend to become pregnant during the study, and
             agree to continue using a reliable method of birth control

        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 previously, in this or any other study, received exenatide or
             glucagon-like peptide-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 have less than 5 years of remission history from any malignancy (other than
             basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ
             prostate 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 biphasic insulin aspart,
             exenatide, or excipients contained in these agents.

          -  Patients have characteristics contraindicating metformin or sulfonylurea use,
             according to product-specific label.

          -  Patients have a history of renal transplantation or are currently receiving renal
             dialysis or have serum creatinine >=1.5 mg/dL for males and >=1.2 mg/dL for females.

          -  Patients have obvious clinical signs or symptoms of liver disease, acute or chronic
             hepatitis, or alanine aminotransferase/serum glutamic pyruvic transaminase greater
             than three times the upper limit of the reference range.

          -  Patients have known hemoglobinopathy or chronic anemia.

          -  Patients have active proliferative retinopathy or macular edema.

          -  Patients are receiving treatment for gastrointestinal disease with a drug directly
             affecting gastrointestinal motility, including but not limited to metoclopramide,
             cisapride, and chronic macrolide antibiotics.

          -  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 been treated for longer than 2 weeks with any of the following excluded
             medications within 3 months prior to screening: insulin, thiazolidinediones,
             alpha-glucosidase inhibitors, meglitinides.

          -  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.