Safety and Efficacy Study of Exenatide Once Weekly in Adolescents With Type 2 Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 14 June 2021
• Main ID: NCT01554618
• Date of registration: 13/03/2012
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: Safety and Efficacy Study of Exenatide Once Weekly in Adolescents With Type 2 Diabetes
• Scientific title: A Phase 3, Double-Blind, Placebo-Controlled, Randomized, Multi-Center Study to Assess the Safety and Efficacy of Exenatide Once Weekly in Adolescents With Type 2 Diabetes
• Date of first enrolment: December 2, 2011
• Target sample size: 84
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01554618
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Bulgaria, Hungary, Israel, Kuwait, Mexico, Ukraine, United States

Key inclusion & exclusion 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



Age minimum: 10 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Children and Adolescent With Type 2 Diabetes

Intervention(s)

Drug: Exenatide Once Weekly

Drug: Placebo

Primary Outcome(s)

Percentage of Patients With On-Treatment Adverse Events (AEs) up to Week 24 (Controlled Assessment Period) [Time Frame: Day 1 (Week 0) up to Week 24, plus up to a maximum of 90 days follow up]

Percentage of Patients Positive for Anti-Drug Antibodies (ADAs) to Exenatide up to Week 24 [Time Frame: Samples were collected on Day 1 (Week 0), Week 4, Week 8, Week 12 and Week 24]

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) to Week 24 (Controlled Assessment Period) [Time Frame: Baseline (Week 0) and Week 24]

Secondary Outcome(s)

Change From Baseline in Fasting Insulin to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period) [Time Frame: Baseline (Week 0) and Week 52]

Change From Baseline in Lipid Profiles to Week 24 (Controlled Assessment Period) [Time Frame: Baseline (Week 0) and Week 24]

Number of Patients Needing Rescue Medication Due to Failure to Maintain Glycemic Control up to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period) [Time Frame: At Week 4, Week 8, Week 12, Week 18, Week 24, Week 28, Week 40 and Week 52]

Change From Baseline in Fasting Plasma Glucose (FPG) Concentration to Week 24 (Controlled Assessment Period) [Time Frame: Baseline (Week 0) and Week 24]

Change From Baseline in Homeostasis Model Assessments - Beta-Cell Function (HOMA-B) and Insulin Sensitivity (HOMA-S) to Week 24 (Controlled Assessment Period) [Time Frame: Baseline (Week 0) and Week 24]

Number of Patients Needing Rescue Medication Due to Failure to Maintain Glycemic Control up to Week 24 (Controlled Assessment Period) [Time Frame: At Week 4, Week 8, Week 12, Week 18 and Week 24]

Change From Baseline in Fasting Insulin to Week 24 (Controlled Assessment Period) [Time Frame: Baseline (Week 0) and Week 24]

Change From Baseline in FPG Concentration to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period) [Time Frame: Baseline (Week 0) and Week 52]

Percentage of Patients Reporting AEs of Injection Site Reactions up to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period) [Time Frame: At Week 4, Week 8, Week 12, Week 18, Week 24, Week 28, Week 40 and Week 52]

Change From Baseline in HOMA-B and HOMA-S to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period) [Time Frame: Baseline (Week 0) and Week 52]

Change From Baseline in Lipids Profiles to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period) [Time Frame: Baseline (Week 0) and Week 52]

Percentage of Patients Achieving HbA1c Goals of < 6.5%, = 6.5%, and < 7.0% at Week 24 (Controlled Assessment Period) [Time Frame: At Week 24]

Change From Baseline in Body Weight to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period) [Time Frame: Baseline (Week 0) and Week 52]

Change From Baseline in HbA1c to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period) [Time Frame: Baseline (Week 0) and Week 52]

Change From Baseline in Blood Pressure (Systolic and Diastolic) to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period) [Time Frame: Baseline (Week 0) and Week 52]

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) to Week 24 (Controlled Assessment Period) [Time Frame: Baseline (Week 0) and Week 24]

Percentage of Participants Achieving HbA1c Goals of < 6.5%, = 6.5%, and < 7.0% to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period) [Time Frame: At Week 52]

Change From Baseline in Body Weight to Week 24 (Controlled Assessment Period) [Time Frame: Baseline (Week 0) and Week 24]

Percentage of Patients Reporting AEs of Injection Site Reactions up to Week 24 (Controlled Assessment Period) [Time Frame: At Week 4, Week 8, Week 12, Week 18 and Week 24]

Plasma Exenatide Concentrations to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period) [Time Frame: Samples were collected on Day 1 (Week 0), Week 4, Week 8, Week 12, Week 24 and Week 52]

Secondary ID(s)

D5551C00002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/12/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01554618