GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes

Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes.

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

122

actual

Study population

Type 2 diabetes

Key I/E criteria

•HbA1c 6.5-10.5%•Age 10-17

Primary endpoints

•HbA1c, change•Post-Treatment Adverse Events of Special Interest (AESI) During Safety (Pancreatitis, Thyroid event)

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 IDNCT00658021

Org study IDD5550C00002

Secondary IDH8O-MC-GWBQcompany identifier

Timeline

Milestones

Study first posted2008-04-14estimated

Study start2008-05-30actual

Primary completion2019-04-18actual

Study completion2020-04-01actual

Last update posted2020-12-01actual

Results first posted2020-12-01actual

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

Inclusion criteria

-patients are eligible to be included in the study only if they meet all of the following criteria:

•are a male or a female between ages 10 to 17 years, inclusive. The number of patients ≥17 years of age will be limited to no more than 10% of patients in each treatment arm

•have a history of type 2 diabetes with the original diagnosis based on at least one American Diabetes Association (ADA) diagnostic criteria

•have been treated with metformin, an SU, or both metformin and an SU (with or without diet and exercise), for at least 3 months or are naïve to anti-diabetes agents and being treated with diet and exercise alone. The dose of oral agent(s) should be stable for the 30 days prior to the screening visit

•have fasting C-peptide >0.6 ng/mL

•have HbA1c between 6.5% and 10.5%, inclusive.

Disease Diagnostic Criteria-for the purposes of this study, patients with type 2 diabetes are defined by:

•diagnosis of type 2 diabetes, as determined by ADA diagnostic criteria and antibody testing, documented and confirmed in the patient's medical record, which includes laboratory determinations consistent with one or more of the following in the patient's medical history

•fasting blood glucose 126 mg/dL (7.0 mmol/L)

•random blood glucose 200 mg/dL (11.1 mmol/L)

•two-hour OGTT (Oral Glucose Tolerance Test) ≥ 200 mg/dL (11.1 mmol/L) AND one or more of the following: no antibodies to GAD65 OR no antibodies to islet cell antigen (ICA512).

Exclusion criteria

-patients will be excluded from the study if they meet any of the following criteria:

•have previously been exposed to exenatide or, completed or withdrawn from this study or any other study investigating exenatide

•are unwilling or unable to inject the study medication

•currently use inhaled steroids at a dose equal to or above 1000g Flovent (fluticasone propionate) daily

•have used oral steroids within the last 60 days or more than 20 days use within the past year

•have used any weight loss medication(s) within 30 days of screening

•have used insulin for more than 10 weeks during the 3 months prior to screening

•have history of renal disease, or serum creatinine >1.6 mg/dL (141.4 µmol/L) (males) or >1.4 mg/dL (123.8 µmol/L) (females)

•have hepatic dysfunction, defined by aspartate (AST) or alanine (ALT) transaminase >3.0 times the upper limit of normal (ULN).

Endpoints (9)

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

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Adjusted Change From Baseline in Body Weight Through Week 28

Time frame:Baseline (Day 1) up to Week 28

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilogram	95% CI
Total Exenatide Twice Daily (EBID)Week 4	-0.89	—
Week 12	-1.09	—
Week 20	-0.71	—
Week 28	-0.81	—
PlaceboWeek 4	0.04	—
Week 12	-0.42	—
Week 20	-0.33	—
Week 28	-0.36	—

LS Mean Difference-0.9395% CI-1.58 – -0.28p0.005Mixed Models Analysis

LS Mean Difference-0.6895% CI-2.00 – 0.65p0.314Mixed Models Analysis

LS Mean Difference-0.3795% CI-2.24 – 1.50p0.692Mixed Models Analysis

LS Mean Difference-0.4495% CI-2.56 – 1.68p0.679Mixed Models Analysis

Glycemic / diabetes

6 endpoints

Primary/protocol endpoint

Adjusted Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 28

Time frame:Baseline (Day 1) and Week 28

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage (%HbA1c)	95% CI
Total Exenatide Twice Daily (EBID)	0.11	—
Placebo	0.38	—

LS Mean Difference-0.2895% CI-1.01 – 0.45p0.444Mixed Models Analysis

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c Goals of < 7%, <= 6.5%, and < 6.5% Through Week 28

Time frame:Weeks 0, 4, 12, 20 and 28

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Total Exenatide Twice Daily (EBID)HbA1c < 7%: Week 0	37.2	26.5 – 47.9
HbA1c < 7%: Week 4	44.9	33.8 – 55.9
HbA1c < 7%: Week 12	43.6	32.6 – 54.6
HbA1c < 7%: Week 20	35.9	25.3 – 46.5
HbA1c < 7%: Week 28	33.3	22.9 – 43.8
HbA1c <=6.5%: Week 0	17.9	9.4 – 26.5
HbA1c <=6.5%: Week 4	29.5	19.4 – 39.6
HbA1c <=6.5%: Week 12	33.3	22.9 – 43.8
HbA1c <=6.5%: Week 20	24.4	14.8 – 33.9
HbA1c <=6.5%: Week 28	23.1	13.7 – 32.4
HbA1c <6.5%: Week 0	15.4	7.4 – 23.4
HbA1c <6.5%: Week 4	26.9	17.1 – 36.8
HbA1c <6.5%: Week 12	30.8	20.5 – 41.0
HbA1c <6.5%: Week 20	21.8	12.6 – 31.0
HbA1c <6.5%: Week 28	23.1	13.7 – 32.4
PlaceboHbA1c < 7%: Week 0	38.1	23.4 – 52.8
HbA1c < 7%: Week 4	42.9	27.9 – 57.8
HbA1c < 7%: Week 12	33.3	19.1 – 47.6
HbA1c < 7%: Week 20	35.7	21.2 – 50.2
HbA1c < 7%: Week 28	28.6	14.9 – 42.2
HbA1c <=6.5%: Week 0	16.7	5.4 – 27.9
HbA1c <=6.5%: Week 4	23.8	10.9 – 36.7
HbA1c <=6.5%: Week 12	23.8	10.9 – 36.7
HbA1c <=6.5%: Week 20	19.0	7.2 – 30.9
HbA1c <=6.5%: Week 28	19.0	7.2 – 30.9
HbA1c <6.5%: Week 0	7.1	0.0 – 14.9
HbA1c <6.5%: Week 4	21.4	9.0 – 33.8
HbA1c <6.5%: Week 12	19.0	7.2 – 30.9
HbA1c <6.5%: Week 20	19.0	7.2 – 30.9
HbA1c <6.5%: Week 28	14.3	3.7 – 24.9

p0.562Cochran-Mantel-Haenszel

p0.621Cochran-Mantel-Haenszel

p0.229Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Adjusted Change From Baseline in Fasting Serum Glucose (FSG) at Week 28

Time frame:Baseline (Day 1) and Week 28

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), millimoles per liter (mmol/L)	95% CI
Total Exenatide Twice Daily (EBID)	0.791	—
Placebo	1.072	—

LS Mean Difference-0.28195% CI-1.614 – 1.052p0.679ANCOVA

Secondary/protocol endpoint

Adjusted Change From Baseline in Self-Monitored Blood Glucose (SMBG) at Week 28

Time frame:Pre-meal and 2 hours post-meal on Baseline (Day 1) and Week 28

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Total Exenatide Twice Daily (EBID)Pre-meal SMBG	-0.699	—
Post-meal SMBG	-1.029	—
Post-prandial excursion SMBG	-0.181	—
Overall SMBG	-0.877	—
PlaceboPre-meal SMBG	-0.888	—
Post-meal SMBG	-1.542	—
Post-prandial excursion SMBG	-0.391	—
Overall SMBG	-1.193	—

LS Mean Difference0.18995% CI-0.821 – 1.199p0.714ANCOVA

LS Mean Difference0.51395% CI-0.516 – 1.541p0.329ANCOVA

LS Mean Difference0.21095% CI-0.577 – 0.997p0.601ANCOVA

LS Mean Difference0.31695% CI-0.615 – 1.248p0.505ANCOVA

Secondary/protocol endpoint

Adjusted Change From Baseline in Fasting Serum Insulin at Week 28

Time frame:Baseline (Day 1) and Week 28

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), picomoles per liter	95% CI
Total Exenatide Twice Daily (EBID)	1.67	—
Placebo	12.49	—

LS Mean Difference-10.8295% CI-95.48 – 73.84p0.802ANCOVA

Secondary/protocol endpoint

Adjusted Change From Baseline in Homeostasis Model Assessments - Beta-Cell Function (HOMA-B) and Insulin Sensitivity (HOMA-S) at Week 28

Time frame:Baseline (Day 1) and Week 28

HOMA-IR (insulin sensitivity)

change from baseline, improvement

componentsHOMA-IR (insulin sensitivity)

Posted result

Group	Value (least_squares_mean), percentage (%HOMA-B and %HOMA-S)	95% CI
Total Exenatide Twice Daily (EBID)HOMA-B	-25.93	—
HOMA-S	-3.18	—
PlaceboHOMA-B	-22.10	—
HOMA-S	-2.90	—

LS Mean Difference-3.8495% CI-40.19 – 32.51p0.836ANCOVA

LS Mean Difference-0.2895% CI-7.82 – 7.26p0.941ANCOVA

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

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.

event count, event

componentsPancreatitis, Thyroid event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide 5 mcg	0	—
Exenatide 10 mcg	0	—
Placebo	0	—

Secondary/protocol endpoint

Percentage of Participants Discontinuing the Study Due to Failure to Maintain Glycemic Control Through Week 28

Time frame:Weeks 2, 4, 8, 12, 16, 20, 24 and 28

Discontinuation due to AE

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Total Exenatide Twice Daily (EBID)Week 2	0	—
Week 4	0	—
Week 8	0	—
Week 12	1.4	—
Week 16	1.4	—
Week 20	0	—
Week 24	0	—
Week 28	1.6	—
PlaceboWeek 2	0	—
Week 4	2.4	—
Week 8	0	—
Week 12	5.0	—
Week 16	0	—
Week 20	14.7	—
Week 24	6.9	—
Week 28	0	—

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.