Phase 3
Completed N=83
Safety and Efficacy Study of Exenatide Once Weekly in Adolescents With Type 2 Diabetes
Children and Adolescent With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01554618 ↗
Enrolled (actual)
83
Serious AEs
4.6%
Results posted
Dec 2020
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) to Week 24 (Controlled Assessment Period) — -0.36; 0.49 percentage (% HbA1c) — p=0.012
◆ Published Evidence
Established
89citations · ~22 / year
Once-Weekly Exenatide in Youth With Type 2 Diabetes.
Summary
The study examines the Safety and efficacy study of exenatide once weekly in children and adolescents with type 2 diabetes
Linked Publications
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Once-Weekly Exenatide in Youth With Type 2 Diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) to Week 24 (Controlled Assessment Period) |
-0.36; 0.49 | 0.012 sig |
| PRIMARY Percentage of Patients With On-Treatment Adverse Events (AEs) up to Week 24 (Controlled Assessment Period) |
61.0; 73.9; 0; 0; 3.4; 4.3 | — |
| PRIMARY Percentage of Patients Positive for Anti-Drug Antibodies (ADAs) to Exenatide up to Week 24 |
17.0; 30.2; 45.3; 53.8; 38.5; 92.3 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) Concentration to Week 24 (Controlled Assessment Period) |
-5.2; 16.5 | 0.119 |
| SECONDARY Change From Baseline in Body Weight to Week 24 (Controlled Assessment Period) |
-0.59; 0.63 | 0.307 |
| SECONDARY Change From Baseline in Fasting Insulin to Week 24 (Controlled Assessment Period) |
79.6; -15.3 | 0.323 |
| SECONDARY Percentage of Patients Achieving HbA1c Goals of < 6.5%, ≤ 6.5%, and < 7.0% at Week 24 (Controlled Assessment Period) |
19.0; 4.2; 19.0; 4.2; 31.0; 8.3 | 0.077 |
| SECONDARY Change From Baseline in Lipid Profiles to Week 24 (Controlled Assessment Period) |
-0.117; -0.114; -0.035; -0.047; -0.050; -0.110 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) to Week 24 (Controlled Assessment Period) |
-0.7; 2.2; 0.2; -1.3 | 0.284 |
| SECONDARY Number of Patients Needing Rescue Medication Due to Failure to Maintain Glycemic Control up to Week 24 (Controlled Assessment Period) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Homeostasis Model Assessments - Beta-Cell Function (HOMA-B) and Insulin Sensitivity (HOMA-S) to Week 24 (Controlled Assessment Period) |
63.98; -26.39; 0.62; 7.37 | 0.211 |
| SECONDARY Percentage of Patients Reporting AEs of Injection Site Reactions up to Week 24 (Controlled Assessment Period) |
8.5; 8.7; 3.5; 4.3; 1.9; 0 | — |
| SECONDARY Change From Baseline in HbA1c to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period) |
-0.10; 0.53 | — |
| SECONDARY Change From Baseline in FPG Concentration to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period) |
-1.8; 10.6 | — |
| SECONDARY Change From Baseline in Body Weight to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period) |
0.04; -0.04 | — |
| SECONDARY Change From Baseline in Fasting Insulin to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period) |
-32.4; 121.5 | — |
| SECONDARY 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) |
30.8; 23.5; 30.8; 23.5; 35.9; 29.4 | — |
| SECONDARY Change From Baseline in Lipids Profiles to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period) |
-0.188; -0.255; 0.004; -0.076; -0.175; -0.152 | — |
| SECONDARY Change From Baseline in Blood Pressure (Systolic and Diastolic) to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period) |
-0.7; -0.6; 1.1; -2.5 | — |
| SECONDARY 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) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in HOMA-B and HOMA-S to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period) |
-2.58; 42.02; 9.85; 2.36 | — |
| SECONDARY Percentage of Patients Reporting AEs of Injection Site Reactions up to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period) |
10.0; 9.1; 4.0; 4.5; 2.0; 0 | — |
| SECONDARY Plasma Exenatide Concentrations to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period) |
NA; 41.51; 130.60; 163.58; 140.81; NA | — |
Eligibility Criteria
Each patient must meet the following criteria to be enrolled in this study.
- Is a child or an adolescent of 10 to 0.6 ng/L at Visit 1 (Screening)
- 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)
- Has a fasting plasma glucose concentration 3.0 times the upper limit of normal (ULN)
- Renal disease or serum creatinine >1.5 mg/dL (132.6 µmol/L) (males) or 1.4 mg/dL (123.8 µmol/L) (females)
- Gastrointestinal disease deemed significant by the Investigator
- Organ transplantation
- Chronic infection (e.g., tuberculosis, human immunodeficiency virus, hepatitis B virus, or hepatitis C virus)
- Clinically significant malignant disease (with the exception of basal and squamous cell carcinoma of the skin) within 5 years of Visit 1 (Screening)
- Has positive antibody titers to glutamic acid decarboxylase (GAD65) or islet cell antigen (ICA512) at Visit 1 (Screening)
- Has a personal or family history of elevated calcitonin, calcitonin >100 ng/L, medullary thyroid carcinoma, or multiple endocrine neoplasia-2
- 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®])
- Is pregnant
Data sourced from ClinicalTrials.gov (NCT01554618) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.