Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Adjusted Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 28
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 10 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Subcutaneous injection, twice a day
Intervention: Placebo (Drug)
Exenatide 5 µg
Subcutaneous injection, twice a day
Intervention: Exenatide (Drug)
Exenatide 10 µg
Subcutaneous injection, twice a day
Intervention: Exenatide (Drug)
Outcomes
Primary Outcomes
Adjusted Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 28
Time Frame: Baseline (Day 1) and Week 28
Change from baseline in HbA1c is reported as adjusted least square (LS) mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. A mixed model with repeated measures (MMRM) analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.
Number of Participants With Post-Treatment Adverse Events of Special Interest (AESI) During Safety Follow-up Period
Time Frame: From 1 day after the Week 28/ED visit to 3 years after Week 28/ED visit.
Post-treatment adverse events (AEs) were defined as AEs that started or worsened during the off-treatment period (Safety Follow-up Period), which was defined as the day after the Week 28/early discontinuation (ED) visit to the date of completion of the Safety Follow-up Period. The AESIs recorded were as follows: hematological malignancies, thyroid neoplasms, pancreas neoplasms, aplastic anemia, pancreatitis, pregnancy and pregnancy outcomes (including congenital anomalies).
Secondary Outcomes
- Percentage of Participants Achieving HbA1c Goals of < 7%, <= 6.5%, and < 6.5% Through Week 28(Weeks 0, 4, 12, 20 and 28)
- Adjusted Change From Baseline in Body Weight Through Week 28(Baseline (Day 1) up to Week 28)
- Adjusted Change From Baseline in Fasting Serum Glucose (FSG) at Week 28(Baseline (Day 1) and Week 28)
- Adjusted Change From Baseline in Self-Monitored Blood Glucose (SMBG) at Week 28(Pre-meal and 2 hours post-meal on Baseline (Day 1) and Week 28)
- Adjusted Change From Baseline in Fasting Serum Insulin at Week 28(Baseline (Day 1) and Week 28)
- Adjusted Change From Baseline in Homeostasis Model Assessments - Beta-Cell Function (HOMA-B) and Insulin Sensitivity (HOMA-S) at Week 28(Baseline (Day 1) and Week 28)
- Percentage of Participants Discontinuing the Study Due to Failure to Maintain Glycemic Control Through Week 28(Weeks 2, 4, 8, 12, 16, 20, 24 and 28)