A Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: exenatide; insulin lispro; Metformin; Insulin/ Glargine
Intervention description: subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (26 weeks), twice a day; titrated based on pre-meal glucose level; three times a day
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Exenatide; Insulin Lispro
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1036.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes; exenatide; Byetta; insulin lispro; Humalog; insulin glargine; Lantus; Amylin; Lilly

Summary:

      The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a
      day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine
      (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects
      with Type 2 Diabetes Mellitus who have inadequate glycemic control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been taking a basal insulin Glargine, at dose of ≥ 20 units/day, for at least 3
             months prior to study start.

          -  Have been taking basal insulin Glargine at dose of ≥ 20 units/day, in combination with
             1 of the following oral antidiabetic medication (OAM) regimens, for at least 3 months
             prior to study start:

               -  Metformin or immediate-release metformin or extended-release metformin alone at a
                  maximum tolerated and stable dose with no less than 500 mg/day for at least 6
                  weeks prior to study start; or

               -  Metformin or immediate-release metformin or extended-release metformin at a
                  maximum tolerated and stable dose with no less than 500 mg/day for at least 6
                  weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior to
                  study start.

          -  Have an HbA1C > 7.0% and ≤ 10.0%.

          -  Have a body mass index (BMI) between ≥ 25 and ≤ 45 kg/m2.

        Exclusion Criteria:

          -  Are currently taking OAM that is not described above and not allowed with concurrent
             use of insulin per local product label.

          -  Have taken more than 1 week within 1 month prior to the study start any
             glucose-lowering medications not included above either alone or in combination
             formulations, or have used a drug for weight loss (for example, prescription drugs
             such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar
             over-the-counter medications).

          -  Have taken any insulin other than Glargine within the 3 months prior to study start
             for more than 1 week.

          -  Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy
             (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the
             study start.

          -  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.

          -  Have previously completed or been withdrawn from this study after enrollment.