GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

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

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

Lead sponsor

AstraZeneca

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criteria

•HbA1c 6.5-11%•Age 10-17

Primary endpoints

•HbA1c, change•Treatment-emergent AEs (any)•Immunogenicity (ADA)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01554618

Org study IDD5551C00002

Timeline

Milestones

Study start2011-12-02actual

Study first posted2012-03-15estimated

Primary completion2020-05-06actual

Results first posted2020-12-03actual

Study completion2021-05-05actual

Last update posted2021-11-30actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age10 Years

Maximum age17 Years

SexAll

Healthy volunteersNot accepted

Eligibility 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

Endpoints (23)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Safety / tolerability / PK

Cardiometabolic biomarkers

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Body Weight to Week 24 (Controlled Assessment Period)

Time frame:Baseline (Week 0) and Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilogram (kg)	95% CI
Controlled Assessment Period - Exenatide	-0.59	—
Controlled Assessment Period - Placebo	0.63	—

LS Mean Difference-1.2295% CI-3.59 – 1.15p0.307Mixed Models Analysis

Secondary/protocol endpoint

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

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Treatment Period - Exenatide	0.04	—
Treatment Period - Placebo Then Exenatide	-0.04	—

Glycemic / diabetes

12 endpoints

Primary/protocol endpoint

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) to Week 24 (Controlled Assessment Period)

Time frame:Baseline (Week 0) and Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage (% HbA1c)	95% CI
Controlled Assessment Period - Exenatide	-0.36	—
Controlled Assessment Period - Placebo	0.49	—

LS Mean Difference-0.8595% CI-1.51 – -0.19p0.012Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) Concentration to Week 24 (Controlled Assessment Period)

Time frame:Baseline (Week 0) and Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), milligrams per deciliter (mg/dL)	95% CI
Controlled Assessment Period - Exenatide	-5.2	—
Controlled Assessment Period - Placebo	16.5	—

LS Mean Difference-21.695% CI-49.0 – 5.7p0.119Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Fasting Insulin to Week 24 (Controlled Assessment Period)

Time frame:Baseline (Week 0) and Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), picomoles per liter (pmol/L)	95% CI
Controlled Assessment Period - Exenatide	79.6	—
Controlled Assessment Period - Placebo	-15.3	—

LS Mean Difference94.995% CI-95.6 – 285.5p0.323Mixed Models Analysis

Secondary/protocol endpoint

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

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Controlled Assessment Period - ExenatideHbA1c <6 .5%	19.0	8.9 – 29.1
HbA1c ≤ 6.5%	19.0	8.9 – 29.1
HbA1c < 7.0%	31.0	19.1 – 42.9
Controlled Assessment Period - PlaceboHbA1c <6 .5%	4.2	0.0 – 12.2
HbA1c ≤ 6.5%	4.2	0.0 – 12.2
HbA1c < 7.0%	8.3	0.0 – 19.4

Difference14.895% CI1.9 – 27.7p0.077Cochran-Mantel-Haenszel

Treatment difference in HbA1c \< 6.5%: Treatment group comparison was based on CMH test stratified by screening HbA1c (\<9.0% or \>=9.0%). P-value was from the general association statistic.

Difference14.895% CI1.9 – 27.7p0.077Cochran-Mantel-Haenszel

Treatment difference in HbA1c ≤ 6.5%: Treatment group comparison was based on CMH test stratified by screening HbA1c (\<9.0% or \>=9.0%). P-value was from the general association statistic.

Difference22.795% CI6.5 – 39.0p0.020Cochran-Mantel-Haenszel

Treatment difference in HbA1c \< 7.0%: Treatment group comparison was based on CMH test stratified by screening HbA1c (\<9.0% or \>=9.0%). P-value was from the general association statistic.

Secondary/protocol endpoint

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

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Controlled Assessment Period - ExenatideWeek 4	0	—
Week 8	0	—
Week 12	0	—
Week 18	1	—
Week 24	0	—
Controlled Assessment Period - PlaceboWeek 4	0	—
Week 8	0	—
Week 12	0	—
Week 18	0	—
Week 24	0	—

Secondary/protocol endpoint

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

HOMA-IR (insulin sensitivity)

change from baseline, improvement

componentsHOMA-IR (insulin sensitivity), C-peptide AUC

Posted result

Group	Value (least_squares_mean), percentage (%HOMA-B and %HOMA-S)	95% CI
Controlled Assessment Period - ExenatideHOMA-B	63.98	—
HOMA-S	0.62	—
Controlled Assessment Period - PlaceboHOMA-B	-26.39	—
HOMA-S	7.37	—

LS Mean Difference90.3795% CI-57.27 – 238.00p0.211Mixed Models Analysis

LS Mean Difference-6.7595% CI-19.80 – 6.29p0.289Mixed Models Analysis

Secondary/protocol endpoint

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage (% HbA1c)	95% CI
Treatment Period - Exenatide	-0.10	—
Treatment Period - Placebo Then Exenatide	0.53	—

Secondary/protocol endpoint

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

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mg/dL	95% CI
Treatment Period - Exenatide	-1.8	—
Treatment Period - Placebo Then Exenatide	10.6	—

Secondary/protocol endpoint

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, improvement

Posted result

Group	Value (mean), pmol/L	95% CI
Treatment Period - Exenatide	-32.4	—
Treatment Period - Placebo Then Exenatide	121.5	—

Secondary/protocol endpoint

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

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Treatment Period - ExenatideHbA1c < 6.5%	30.8	—
HbA1c ≤ 6.5%	30.8	—
HbA1c < 7.0%	35.9	—
Treatment Period - Placebo Then ExenatideHbA1c < 6.5%	23.5	—
HbA1c ≤ 6.5%	23.5	—
HbA1c < 7.0%	29.4	—

Secondary/protocol endpoint

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

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Treatment Period - ExenatideWeek 4	0	—
Week 8	0	—
Week 12	0	—
Week 18	1	—
Week 24	0	—
Week 28	2	—
Week 40	2	—
Week 52	0	—
Treatment Period - Placebo Then ExenatideWeek 4	0	—
Week 8	0	—
Week 12	0	—
Week 18	0	—
Week 24	0	—
Week 28	1	—
Week 40	0	—
Week 52	0	—

Secondary/protocol endpoint

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

HOMA-IR (insulin sensitivity)

change from baseline, improvement

componentsHOMA-IR (insulin sensitivity)

Posted result

Group	Value (mean), percentage (%HOMA-B and %HOMA-S)	95% CI
Treatment Period - ExenatideHOMA-B	-2.58	—
HOMA-S	9.85	—
Treatment Period - Placebo Then ExenatideHOMA-B	42.02	—
HOMA-S	2.36	—

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint

Change From Baseline in Lipid Profiles to Week 24 (Controlled Assessment Period)

Time frame:Baseline (Week 0) and Week 24

change from baseline, improvement

Posted result

Group	Value (mean), millimoles per liter (mmol/L)	95% CI
Controlled Assessment Period - ExenatideTotal Cholesterol	-0.117	—
HDL-C	-0.035	—
LDL-C	-0.050	—
Triglycerides	-0.122	—
Controlled Assessment Period - PlaceboTotal Cholesterol	-0.114	—
HDL-C	-0.047	—
LDL-C	-0.110	—
Triglycerides	0.094	—

Secondary/protocol endpoint

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

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (least_squares_mean), millimeters mercury (mmHg)	95% CI
Controlled Assessment Period - ExenatideSBP	-0.7	—
DBP	0.2	—
Controlled Assessment Period - PlaceboSBP	2.2	—
DBP	-1.3	—

LS Mean Difference-2.895% CI-8.0 – 2.4p0.284Mixed Models Analysis

LS Mean Difference1.695% CI-2.0 – 5.1p0.376Mixed Models Analysis

Secondary/protocol endpoint

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

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Treatment Period - ExenatideTotal Cholesterol	-0.188	—
HDL-C	0.004	—
LDL-C	-0.175	—
Triglycerides	-0.155	—
Treatment Period - Placebo Then ExenatideTotal Cholesterol	-0.255	—
HDL-C	-0.076	—
LDL-C	-0.152	—
Triglycerides	-0.043	—

Secondary/protocol endpoint

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

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mmHg	95% CI
Treatment Period - ExenatideSBP	-0.7	—
DBP	1.1	—
Treatment Period - Placebo Then ExenatideSBP	-0.6	—
DBP	-2.5	—

Safety / tolerability / PK

5 endpoints

Primary/protocol endpoint

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

Treatment-emergent AEs (any)

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Controlled Assessment Period - ExenatideAny AE	61.0	—
Any AE with outcome of death	0	—
Any SAE	3.4	—
Any AE leading to discontinuation of treatment	0	—
Any AE leading to discontinuation from study	0	—
Any AE related to treatment	25.4	—
Controlled Assessment Period - PlaceboAny AE	73.9	—
Any AE with outcome of death	0	—
Any SAE	4.3	—
Any AE leading to discontinuation of treatment	0	—
Any AE leading to discontinuation from study	0	—
Any AE related to treatment	21.7	—

Primary/protocol endpoint

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

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Treatment Period - ExenatideWeek 4: High Positive	17.0	—
Week 4: Low Positive	30.2	—
Week 4: Treatment-Emergent ADA Positive	45.3	—
Week 8: High Positive	53.8	—
Week 8: Low Positive	38.5	—
Week 8: Treatment-Emergent ADA Positive	92.3	—
Week 12: High Positive	60.0	—
Week 12: Low Positive	38.0	—
Week 12: Treatment-Emergent ADA Positive	98.0	—
Week 24: High Positive	40.8	—
Week 24: Low Positive	55.1	—
Week 24: Treatment-Emergent ADA Positive	95.9	—

Secondary/protocol endpoint

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

descriptive, event

Posted result

Group	Value (number), percentage of participants	95% CI
Controlled Assessment Period - ExenatideWeek 4	8.5	—
Week 8	3.5	—
Week 12	1.9	—
Week 18	0	—
Week 24	0	—
Controlled Assessment Period - PlaceboWeek 4	8.7	—
Week 8	4.3	—
Week 12	0	—
Week 18	0	—
Week 24	0	—

Secondary/protocol endpoint

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

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Treatment Period - ExenatideWeek 4	10.0	—
Week 8	4.0	—
Week 12	2.0	—
Week 18	0	—
Week 24	0	—
Week 28	4.0	—
Week 40	0	—
Week 52	0	—
Treatment Period - Placebo Then ExenatideWeek 4	9.1	—
Week 8	4.5	—
Week 12	0	—
Week 18	0	—
Week 24	0	—
Week 28	0	—
Week 40	0	—
Week 52	0	—

Secondary/protocol endpoint

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

Plasma concentration (steady state)

concentration, descriptive

Posted result

Group	Value (geometric_mean), picograms per milliliter	95% CI
Treatment Period - ExenatideBaseline	NA	—
Week 4	41.51	—
Week 8	130.60	—
Week 12	163.58	—
Week 24	140.81	—
Week 52	88.88	—
Treatment Period - Placebo Then ExenatideWeek 24	NA	—
Week 52	105.56	—

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Once-Weekly Exenatide in Youth With Type 2 Diabetes.
Diabetes care2022 Aug 1PMID35679098doi:10.2337/dc21-2275via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.