Safety and Efficacy Study of Exenatide Once Weekly in Adolescents With Type 2 Diabetes
Condition: Children and Adolescent With Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Exenatide Once Weekly; Placebo
Intervention description: 2 mg exenatide once weekly; Placebo
Intervention MeSH terms: Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: exenatide; type 2 diabetes; GLP-1 receptor agonist

Summary:

      The study examines the Safety and efficacy study of exenatide once weekly in children and
      adolescents with type 2 diabetes
    

Eligibility criteria:

        Each patient must meet the following criteria to be enrolled in this study.

          1. Is a child or an adolescent of 10 to <18 years old, at Visit 1 (Screening)

          2. Has been diagnosed with type 2 diabetes mellitus per American Diabetes Association
             diagnostic criteria

          3. HbA1c of 6.5% to 11.0%, inclusive, in patients not taking insulin/SU, and of 6.5% to
             12.0%, inclusive, in patients taking insulin/SU, at Visit 1 (Screening)

          4. Has a C-peptide of >0.6 ng/L at Visit 1 (Screening)

          5. Has been treated with diet and exercise alone or in combination with a stable dose of
             an oral antidiabetic agent (e.g., metformin and/or SU) and/or insulin for their type 2
             diabetes for at least 2 months prior to Visit 1 (Screening)

          6. Has a fasting plasma glucose concentration <280 mg/dL (15.5 mmol/L) at Visit 1
             (Screening)

        Patients who meet any of the following criteria will be excluded from the study.

          1. Has a clinically significant medical condition that could potentially affect study
             participation and/or personal well-being, as judged by the Investigator, including but
             not limited to the following conditions:

               1. Hepatic disease (defined by aspartate or alanine transaminase >3.0 times the
                  upper limit of normal (ULN)

               2. Renal disease or serum creatinine >1.5 mg/dL (132.6 µmol/L) (males) or 1.4 mg/dL
                  (123.8 µmol/L) (females)

               3. Gastrointestinal disease deemed significant by the Investigator

               4. Organ transplantation

               5. Chronic infection (e.g., tuberculosis, human immunodeficiency virus, hepatitis B
                  virus, or hepatitis C virus)

               6. Clinically significant malignant disease (with the exception of basal and
                  squamous cell carcinoma of the skin) within 5 years of Visit 1 (Screening)

          2. Has positive antibody titers to glutamic acid decarboxylase (GAD65) or islet cell
             antigen (ICA512) at Visit 1 (Screening)

          3. Has a personal or family history of elevated calcitonin, calcitonin >100 ng/L,
             medullary thyroid carcinoma, or multiple endocrine neoplasia-2

          4. Has ever used exenatide (exenatide once weekly [exenatide LAR], exenatide BID, BYETTA,
             or any other formulation) or any glucagon-like peptide-1 (GLP-1) receptor agonist
             (e.g., liraglutide [Victoza®])

          5. Is pregnant