GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo

A 28-week, Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study With a 24-week Extension Phase Followed by a 52-week Extension Phase to Evaluate the Efficacy and Safety of Simultaneous Administration of Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg Compared to Exenatide Once Weekly 2 mg Alone and Dapagliflozin Once Daily 10 mg Alone in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin

Lead sponsor

AstraZeneca

Asset

Exenatide

GLP-1 agonist

Listed sites

133

Recruiting sites

—

Enrollment

695

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 8-12%

Primary endpoint

•HbA1c, change

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 IDNCT02229396

Org study IDD5553C00003

Secondary ID2014-003503-29

Timeline

Milestones

Study first posted2014-09-01estimated

Study start2014-09-04actual

Primary completion2016-04-26actual

Results first posted2017-09-08actual

Study completion2017-12-28actual

Last update posted2018-12-31actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age130 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Has a diagnosis of T2DM.

•Has HbA1c of 8.0% to 12.0%, inclusive, at Visit 1 and Visit 2.

•Treated with a stable dose of metformin ≥1500 mg/day for at least 2 months prior to Screening.

Exclusion criteria

•FPG ≥280 mg/dL (15.6 mmol/L).

•Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)

•Clinically significant abnormal free T4 values or patients needing initiation or adjustment of thyroid treatment according to the investigator.

•Abnormal thyroid stimulating hormone (TSH) value at Screening will be further evaluated by free T4.Patients with clinically significant abnormal free T4 values will be excluded.

•Known active proliferative retinopathy.

•History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1

•History or presence of inflammatory bowel disease or other severe GI diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis.

•History of gastric bypass surgery or gastric banding surgery, or either procedure is planned during the time period of the study. Current use of gastric balloons is also excluded.

Endpoints (8)

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

Weight & body composition

Cardiometabolic biomarkers

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change in Body Weight From Baseline to Week 28

Time frame:Baseline to Week 28

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilogram	95% CI
Dapagliflozin + Placebo	-2.22	-2.78 – -1.66
Exenatide + Dapagliflozin	-3.55	-4.12 – -2.99
Exenatide + Placebo	-1.56	-2.13 – -0.98

Mean Difference (Final Values)-2.0095% CI-2.79 – -1.20p<0.001Mixed Models Analysis

Mean Difference (Final Values)-1.3395% CI-2.12 – -0.55p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28

Time frame:Baseline to Week 28

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), % of patients	95% CI
Dapagliflozin + Placebo	20.0	14.8 – 25.2
Exenatide + Dapagliflozin	33.3	27.2 – 39.5
Exenatide + Placebo	13.7	9.2 – 18.1

Difference in percentages19.7p<0.001Cochran-Mantel-Haenszel

Difference in percentages13.3p0.001Cochran-Mantel-Haenszel

Glycemic / diabetes

5 endpoints

Primary/protocol endpoint

Change in HbA1c From Baseline to Week 28

Time frame:Baseline to Week 28

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), % HbA1c	95% CI
Dapagliflozin + Placebo	-1.39	-1.57 – -1.21
Exenatide + Dapagliflozin	-1.98	-2.16 – -1.79
Exenatide + Placebo	-1.60	-1.79 – -1.41

Mean Difference (Final Values)-0.3895% CI-0.63 – -0.13p0.003Mixed Models Analysis

Mean Difference (Final Values)-0.5995% CI-0.84 – -0.34p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Change in Fasting Plasma Glucose From Baseline to Week 28

Time frame:Baseline to Week 28

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), milligrams/deciliter (mg/dL)	95% CI
Dapagliflozin + Placebo	-49.19	-54.91 – -43.47
Exenatide + Dapagliflozin	-65.83	-71.60 – -60.06
Exenatide + Placebo	-45.75	-51.67 – -39.83

Mean Difference (Final Values)-20.0895% CI-27.95 – -12.20p<0.001Mixed Models Analysis

Mean Difference (Final Values)-16.6495% CI-24.39 – -8.89p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test

Time frame:Baseline to Week 28

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Dapagliflozin + Placebo	-61.05	-69.10 – -53.00
Exenatide + Dapagliflozin	-87.83	-95.83 – -79.84
Exenatide + Placebo	-60.09	-68.48 – -51.71

Mean Difference (Final Values)-27.7495% CI-37.89 – -17.59p<0.001ANCOVA

Mean Difference (Final Values)-26.7895% CI-36.78 – -16.78p<0.001ANCOVA

Secondary/protocol endpoint

Change in Fasting Plasma Glucose From Baseline to Week 2

Time frame:Baseline to Week 2

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Dapagliflozin + Placebo	-26.31	-31.42 – -21.20
Exenatide + Dapagliflozin	-41.34	-46.48 – -36.20
Exenatide + Placebo	-21.08	-26.29 – -15.86

Mean Difference (Final Values)-20.2695% CI-27.12 – -13.40p<0.001Mixed Models Analysis

Mean Difference (Final Values)-15.0395% CI-21.85 – -8.20p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c <7% at Week 28

Time frame:Baseline to Week 28

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), % of patients	95% CI
Dapagliflozin + Placebo	19.1	14.1 – 24.2
Exenatide + Dapagliflozin	44.7	38.3 – 51.2
Exenatide + Placebo	26.9	21.1 – 32.6

Difference in percentages17.9p<0.001Cochran-Mantel-Haenszel

Difference in percentages25.6p<0.001Cochran-Mantel-Haenszel

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Change in Systolic Blood Pressure From Baseline to Week 28

Time frame:Baseline to Week 28

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (least_squares_mean), millimeters of mercury (mmHg)	95% CI
Dapagliflozin + Placebo	-1.8	-3.4 – -0.3
Exenatide + Dapagliflozin	-4.3	-5.8 – -2.7
Exenatide + Placebo	-1.2	-2.8 – 0.4

Mean Difference (Final Values)-3.095% CI-5.2 – -0.9p0.005Mixed Models Analysis

Mean Difference (Final Values)-2.495% CI-4.5 – -0.4p0.022Mixed Models Analysis

Publications (4)

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

Efficacy and Safety Over 2 Years of Exenatide Plus Dapagliflozin in the DURATION-8 Study: A Multicenter, Double-Blind, Phase 3, Randomized Controlled Trial.
Diabetes care2020 Oct (month)PMID32816874doi:10.2337/dc19-1350via clinicaltrials gov reference derived + pubmed nct search
Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease.
Diabetes therapy : research, treatment and education of diabetes and related disorders2020 Jul (month)PMID32306296doi:10.1007/s13300-020-00815-zvia clinicaltrials gov reference derived + pubmed nct search
Safety and Efficacy of Exenatide Once Weekly Plus Dapagliflozin Once Daily Versus Exenatide or Dapagliflozin Alone in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy: 52-Week Results of the DURATION-8 Randomized Controlled Trial.
Diabetes care2018 Oct (month)PMID30082326doi:10.2337/dc18-0680via clinicaltrials gov reference derived + pubmed nct search
Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION-8): a 28 week, multicentre, double-blind, phase 3, randomised controlled trial.
The lancet. Diabetes & endocrinology2016 Dec (month)PMID27651331doi:10.1016/S2213-8587(16)30267-4via 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.