Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: placebo; exenatide
Intervention description: subcutaneous injection, twice a day; subcutaneous injection, twice a day, 10mcg
Intervention MeSH terms: Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 261.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes; exenatide; Amylin; Lilly; metformin; pioglitazone; insulin glargine

Summary:

      This study will compare the efficacy and safety of exenatide versus placebo in adults whose
      diabetes is not fully controlled by insulin glargine with or without metformin and/or
      pioglitazone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 2 diabetes.

          -  Have been taking insulin glargine at a dose of ≥20 units/day for at least 3 months
             before entering the study.

        Have been taking insulin glargine alone or in combination with one of the following for at
        least 3 months before entering the study:

          1. metformin (stable dose for 6 weeks)

          2. pioglitazone (stable dose for 6 weeks)

          3. a combination of metformin and pioglitazone (stable dose for 6 weeks)

               -  Have HbA1C between 7.1% and 10.5%, inclusive.

               -  Have a body mass index (BMI) ≤45 kg/m2.

               -  Have a history of stable body weight (not varying by >5% for at least 3 months
                  prior to screening).

        Exclusion Criteria:

          -  Have taken medications to lower blood sugar other than insulin glargine, pioglitazone,
             or metformin in the 3 months before entering the study for more than a 1-week period,
             or within 1 week of entering the study.

          -  Have had more than one episode of major (severe) hypoglycemia in the 6 months before
             entering the study.

          -  Are pregnant or intend to become pregnant during the study or are sexually active
             women not actively practicing birth control.

          -  Women who are breastfeeding.

          -  Have any significant diseases of the blood, heart, kidney, gastrointestinal system, or
             other significant diseases such as cancer.

          -  Have had a kidney transplant or are currently on kidney dialysis.

          -  Have a cancer that's never been treated, that's currently being treated, or that was
             diagnosed within the last 5 years.

          -  Have had a bad reaction to exenatide in the past or have a condition that is not
             recommended to be exposed to exenatide or any of exenatide's other ingredients.

          -  Have used a drug for weight loss in the 3 months before entering the study for more
             than a 1-week period, or within 1 month of entering the study.

          -  Are currently on a weight-loss program or have been on one within 3 months of entering
             the study.

          -  Have had a blood transfusion or severe blood loss within 3 months of entering the
             study.

          -  Are taking systemic glucocorticoids or have received systemic glucocorticoids within 8
             weeks of entering the study.

          -  Have an irregular sleep cycle (for example, sleeping during the day and working during
             the night).

          -  Have a history of pancreatitis.

          -  Have received treatment with an experimental drug within 30 days of entering the
             study.

          -  If on metformin, have a condition that is not recommended to be exposed to metformin,
             or any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis.

          -  If on metformin, have had a radiologic contrast study performed within 48 hours of
             entering the study.

          -  If on pioglitazone, have a condition that is not recommended to be exposed to
             pioglitazone, including congestive heart failure, or are taking pioglitazone at a dose
             that is not approved for use with insulin.