GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Once Weekly Exenatide Therapy Added to Titrated Basal Insulin Glargine Compared to Placebo Added to Titrated Basal Insulin Glargine in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Glargine With or Without Metformin

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

123

Recruiting sites

—

Enrollment

464

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7.5-12%

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 IDNCT02229383

Org study IDD5553C00002

Secondary ID2014-003502-33

Timeline

Milestones

Study first posted2014-09-01estimated

Study start2014-09-06actual

Primary completion2016-08-29actual

Study completion2016-08-29actual

Results first posted2017-09-18actual

Last update posted2019-01-08actual

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 Type 2 Diabetes Mellitus (T2DM)

•Has HbA1c of 7.5% to 12.0%, inclusive, at Visit 1 (Screening).

•Has fasting plasma glucose (FPG) concentration <280 mg/dL (15.6 mmol/L) at Visit 1 (Screening)

•Treated with basal insulin glargine at a dose of ≥20 units/day once daily for at least 6 weeks prior to Screening, in combination with diet and exercise alone or in combination with:

1. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1

2. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1 (Screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the Screening visit

Exclusion criteria

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

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

•Positive serological test for hepatitis B or hepatitis C

Endpoints (7)

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

1 endpoint

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
Exenatide	-1.04	-1.54 – -0.53
Placebo	0.48	-0.02 – 0.98

Mean Difference (Final Values)-1.5295% CI-2.19 – -0.85p<0.001Mixed Models Analysis

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), Percentage of HbA1c	95% CI
Exenatide	-0.96	-1.12 – -0.81
Placebo	-0.22	-0.38 – -0.07

Mean Difference (Final Values)-0.7495% CI-0.94 – -0.54p<0.001Mixed Models Analysis

Secondary/protocol endpoint

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

Time frame:Baseline to Week 28

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), milligram per deciliter	95% CI
Exenatide	-28.73	-40.0 – -17.45
Placebo	-0.96	-12.41 – 10.48

Mean Difference (Final Values)-27.7695% CI-39.07 – -16.45p<0.001ANCOVA

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c <7.0% at Week 28

Time frame:Baseline to Week 28

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Exenatide	32.6	26.6 – 38.7
Placebo	7.0	3.7 – 10.3

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

Secondary/protocol endpoint/low confidence

Change From Baseline to Week 28 in Daily Insulin Dose

Time frame:Baseline to Week 28

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units	95% CI
Exenatide	1.6	0.1 – 3.1
Placebo	3.5	2.0 – 5.1

Mean Difference (Final Values)-1.995% CI-4.1 – 0.2p0.074Mixed Models Analysis

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c <7.0% at Week 28, No Weight Gain at Week 28, and No Major Hypoglycemia Over 28 Weeks

Time frame:Baseline to Week 28

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Severe hypoglycemia

Posted result

Group	Value (number), Percentage of participants	95% CI
Exenatide	22.2	16.8 – 27.5
Placebo	2.2	0.3 – 4.1

Difference in percentages20.0p<0.001Cochran-Mantel-Haenszel

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Change in Seated 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), millimeter of mercury	95% CI
Exenatide	-2.5	-4.4 – -0.7
Placebo	-0.7	-2.6 – 1.1

Mean Difference (Final Values)-1.895% CI-4.0 – 0.4p0.110Mixed Models Analysis

Publications (2)

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

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
Effect of exenatide QW or placebo, both added to titrated insulin glargine, in uncontrolled type 2 diabetes: The DURATION-7 randomized study.
Diabetes, obesity & metabolism2018 Jul (month)PMID29473704doi:10.1111/dom.13266via 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.