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

• Status: Completed
• Trial end date: 2021-05-05
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Exenatide

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