Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; Exenatide; Exenatide
Intervention description: Subcutaneous injection, twice a day; Subcutaneous injection, 5 µg, twice a day; Subcutaneous injection,10 µg, twice a day
Intervention MeSH terms: Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 122.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: diabetes; adolescents; exenatide; Astra Zeneca

Summary:

      The primary objective of this study is to test the hypothesis that glycemic control, as
      measured by change in hemoglobin A1c (HbA1c) from baseline to endpoint, with exenatide is
      superior to that of placebo after 28 weeks of treatment in adolescent patients with type 2
      diabetes who are naïve to antidiabetes agents, or patients who are being treated with
      metformin, an SU, or a combination of metformin and an SU
    

Eligibility criteria:

        Inclusion Criteria-patients are eligible to be included in the study only if they meet all
        of the following criteria:

          -  are a male or a female between ages 10 to 17 years, inclusive. The number of patients
             ≥17 years of age will be limited to no more than 10% of patients in each treatment arm

          -  have a history of type 2 diabetes with the original diagnosis based on at least one
             American Diabetes Association (ADA) diagnostic criteria

          -  have been treated with metformin, an SU, or both metformin and an SU (with or without
             diet and exercise), for at least 3 months or are naïve to anti-diabetes agents and
             being treated with diet and exercise alone. The dose of oral agent(s) should be stable
             for the 30 days prior to the screening visit

          -  have fasting C-peptide >0.6 ng/mL

          -  have HbA1c between 6.5% and 10.5%, inclusive.

        Disease Diagnostic Criteria-for the purposes of this study, patients with type 2 diabetes
        are defined by:

          -  diagnosis of type 2 diabetes, as determined by ADA diagnostic criteria and antibody
             testing, documented and confirmed in the patient's medical record, which includes
             laboratory determinations consistent with one or more of the following in the
             patient's medical history

          -  fasting blood glucose 126 mg/dL (7.0 mmol/L)

          -  random blood glucose 200 mg/dL (11.1 mmol/L)

          -  two-hour OGTT (Oral Glucose Tolerance Test) ≥ 200 mg/dL (11.1 mmol/L) AND one or more
             of the following: no antibodies to GAD65 OR no antibodies to islet cell antigen
             (ICA512).

        Exclusion Criteria-patients will be excluded from the study if they meet any of the
        following criteria:

          -  have previously been exposed to exenatide or, completed or withdrawn from this study
             or any other study investigating exenatide

          -  are unwilling or unable to inject the study medication

          -  currently use inhaled steroids at a dose equal to or above 1000g Flovent (fluticasone
             propionate) daily

          -  have used oral steroids within the last 60 days or more than 20 days use within the
             past year

          -  have used any weight loss medication(s) within 30 days of screening

          -  have used insulin for more than 10 weeks during the 3 months prior to screening

          -  have history of renal disease, or serum creatinine >1.6 mg/dL (141.4 µmol/L) (males)
             or >1.4 mg/dL (123.8 µmol/L) (females)

          -  have hepatic dysfunction, defined by aspartate (AST) or alanine (ALT) transaminase
             >3.0 times the upper limit of normal (ULN).