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
Study type: Interventional
Phase: Phase 3

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

Detailed description: 
      This Phase 3, double-blind (controlled assessment period), randomized, multicenter,
      placebo-controlled parallel study is designed to examine the efficacy and safety of EQW
      compared to placebo (PBO) in adolescents with type 2 diabetes for 24 weeks. This study will
      assess safety and efficacy of EQW (as monotherapy and adjunctive therapy to oral antidiabetic
      agents and/or insulin). At least 40% and not more than 60% of the randomized patients must be
      females. At least 40% of patients should be recruited from areas with similar ethnicity and
      lifestyle to those of the European Union member states. Long term safety and efficacy of EQW
      will subsequently be monitored for 28 weeks in the open-label, uncontrolled extension period
      (through Week 52). The study will be terminated at Visit 11 (Week 62/Study Termination) which
      will be a follow-up visit occurring 10 weeks after the last dose administration at Visit 10
      (Week 52). This study will be conducted in 77 patients with type 2 diabetes treated with diet
      and exercise alone or in combination with a stable dose of oral antidiabetic agents and/or
      insulin for at least 2 months prior to screening. During the controlled assessment period,
      approximately 77 patients will be randomly assigned in a 5:2 ratio to either EQW 2 mg (Group
      A) or PBO (Group B), to yield at least 70 evaluable patients: at least 50 patients in the
      exenatide and at least 20 patients in the PBO group. Following the 24-week controlled
      assessment period, patients assigned to the EQW 2 mg treatment (Group A) will continue to be
      treated with EQW 2 mg during the extension period (through Week 52). Patients randomized to
      PBO (Group B) will receive EQW 2 mg beginning at the start of the extension period, Week 25
      through Week 52. In addition to receiving study medications, all patients will participate in
      a lifestyle intervention program encompassing diet and physical activity modifications
      following the signing of the informed consent and assent forms (Visit 1 [Week -2]) through
      the end of the extension period (Week 52). Following Visit 11 (Week 62/Study Termination),
      patients whose height increase is at least 5 mm between Visit 8 (Week 28) and Visit 11 (Week
      62/Study Termination) will participate in a long-term safety follow-up period. Patients who
      discontinue study medication prior to Visit 11 (Week 62/Study Termination) will also
      participate in the Extended Safety Follow-up Period, unless they have a height increase of
      less than 5 mm over a 6-month interval at study site visits prior to discontinuation of study
      medication. Patients who do not have height assessments at study-site visits over a 6-month
      interval prior to discontinuation of study medication will enter the Extended Safety
      Follow-up Period. The Extended Safety Follow Up Period will continue for up to 3 years or
      until the difference between two 6-month interval visits is less than a 5 mm increase
      (whichever comes first). No study medication will be administered during the Extended Safety
      Follow-up Period. Blood samples will be collected for calcitonin and carcinoembryonic antigen
      (CEA) laboratory measurements.
    

Intervention name(s): Exenatide Once Weekly; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 mg exenatide once weekly; Placebo
Other intervention name(s): BYDUREON
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: exenatide; type 2 diabetes; GLP-1 receptor agonist