GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes

Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes and Inadequate Glycemic Control Treated With Lifestyle Modification and Oral Antidiabetic Medications

Lead sponsor

AstraZeneca

Assets

Exenatide / Liraglutide

Listed sites

108

Recruiting sites

—

Enrollment

912

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤45•HbA1c 7.1-11%

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 IDNCT01029886

Org study IDH8O-MC-GWDE

Timeline

Milestones

Study first posted2009-12-10estimated

Results first posted2012-03-21estimated

Last update posted2015-04-09estimated

Study start2010-01 (month precision)

Primary completion2011-01actual (month precision)

Study completion2011-04actual (month precision)

Assets

Investigational agents

Exenatide Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosed with type 2 diabetes

•Have suboptimal glycemic control as evidenced by an HbA1c measurement at study start 7.1% and 11.0%, inclusive

•Have a body mass index (BMI) ≤45 kg/m^2

•Have been treated with lifestyle modification (diet and exercise) and with one of the following single oral antidiabetic agents (OADs) or combinations of OADs administered at maximum tolerated dose:

–metformin

–SU

–metformin plus an SU

–metformin plus pioglitazone

Exclusion criteria

•Have any contraindication, allergy, or hypersensitivity for the study drug (exenatide once weekly or liraglutide), exenatide twice daily, the OAD(s) being used, or the excipients contained in these agents

•If taking metformin and have a contraindication to metformin use

•Have been treated within 8 weeks of study start with systemic glucocorticoid therapy by oral, intravenous, intra-articular, or intramuscular route

•Have been treated with drugs that promote weight loss (e.g., Xenical® [orlistat], Meridia® [sibutramine], Acomplia® [rimonabant], Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of study start

•Have taken any of the following excluded medications for more than 1 week within the 3 months prior to study start, or have taken any of the following excluded medications within 1 month prior to study start:

–Insulin

–Alpha-glucosidase inhibitors (e.g., Glyser® [miglitol] or Precose® [acarbose])

–Meglitinides (e.g., Prandin® [repaglinide] or Starlix® [nateglinide])

–Avandia® (rosiglitazone)

–Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia™ [sitagliptin], Galvus® [vildagliptin], Onglyza™ [saxagliptin])

–Symlin® (pramlintide acetate)

•Have donated blood within 30 days prior to study start or have had a blood transfusion or severe blood loss within 3 months prior to study start

•Have at any time, including a clinical trial, taken exenatide once weekly, exenatide twice daily, liraglutide, or any other GLP-1 receptor agonist or GLP-1 analog

•Are currently enrolled in, or discontinued within the last 3 months or longer if required by local guidelines, from a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

•Have previously been screen-failed from this study for any reason

•If a subject discontinues metformin, sulfonylurea, or pioglitazone prior to screening, the subject can be included if they discontinued the medication (whether alone or as component of combined medication) according to a specific schedule.

Endpoints (20)

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

Cardiometabolic biomarkers

Glycemic / diabetes

Weight & body composition

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/registry result

Change in Body Weight From Baseline to Week 26

Time frame:Baseline, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Exenatide Once Weekly	-2.68	—
Liraglutide Once Daily	-3.57	—

Least Squares Mean Difference0.9095% CI0.39 – 1.40p<.001Mixed Models Analysis

MMRM model includes treatment, baseline body weight, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.

Secondary/protocol endpoint

Change in Body Weight From Baseline to Week 26

Time frame:Baseline, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Primary/registry result

Change in HbA1c From Baseline to Week 26

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of total hemoglobin	95% CI
Exenatide Once Weekly	-1.28	—
Liraglutide Once Daily	-1.48	—

Least Squares Mean Difference0.2195% CI0.08 – 0.33p0.002Mixed Models Analysis

Primary/protocol endpoint

Change in HbA1c From Baseline to Week 26

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Percentage of Patients Achieving HbA1c <7.0% at Week 26

Time frame:Baseline, Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of patients	95% CI
Exenatide Once Weekly	52.7	—
Liraglutide Once Daily	60.2	—

p0.011Cochran-Mantel-Haenszel

Secondary/registry result

Change in Fasting Serum Glucose From Baseline to Week 26

Time frame:Baseline, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide Once Weekly	-1.76	—
Liraglutide Once Daily	-2.12	—

Least Squares Mean Difference0.3695% CI0.05 – 0.66p0.021Mixed Models Analysis

Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c <7.0% at Week 26

Time frame:Baseline, Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Serum Glucose From Baseline to Week 26

Time frame:Baseline, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

10 endpoints

Secondary/registry result

Change in Total Cholesterol From Baseline to Week 26

Time frame:Baseline, Week 26

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide Once Weekly	-0.06	—
Liraglutide Once Daily	-0.15	—

Least Squares Mean Difference0.0995% CI-0.01 – 0.19p0.079Mixed Models Analysis

Secondary/registry result

Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26

Time frame:Baseline, Week 26

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide Once Weekly	0.02	—
Liraglutide Once Daily	0.02	—

Least Squares Mean Difference0.0095% CI-0.02 – 0.02p0.832Mixed Models Analysis

MMRM model includes treatment, baseline HDL-C, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.

Secondary/registry result

Ratio of Fasting Triglycerides at Week 26 to Baseline

Time frame:Baseline, Week 26

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (least_squares_mean), ratio	95% CI
Exenatide Once Weekly	0.97	—
Liraglutide Once Daily	0.89	—

Least Squares Mean Difference1.0995% CI1.04 – 1.15p<.001Mixed Models Analysis

Secondary/registry result

Change in Systolic Blood Pressure (SBP) From Baseline to Week 26

Time frame:Baseline, Week 26

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Exenatide Once Weekly	-2.48	—
Liraglutide Once Daily	-3.45	—

Least Squares Mean Difference0.9795% CI-0.53 – 2.47p0.205Mixed Models Analysis

MMRM model includes treatment, baseline SBP, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.

Secondary/registry result

Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26

Time frame:Baseline, Week 26

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Exenatide Once Weekly	-0.49	—
Liraglutide Once Daily	-0.51	—

Least Squares Mean Difference0.0195% CI-0.96 – 0.98p0.981Mixed Models Analysis

MMRM model includes treatment, baseline DBP, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.

Secondary/protocol endpoint

Change in Total Cholesterol From Baseline to Week 26

Time frame:Baseline, Week 26

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26

Time frame:Baseline, Week 26

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Ratio of Fasting Triglycerides at Week 26 to Baseline

Time frame:Baseline, Week 26

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Systolic Blood Pressure (SBP) From Baseline to Week 26

Time frame:Baseline, Week 26

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26

Time frame:Baseline, Week 26

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Safety / tolerability / PK

2 endpoints

Secondary/registry result

Assessment of Event Rate of Treatment-emergent Hypoglycemic Events

Time frame:Baseline to Week 26

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), events per subject-year	95% CI
Exenatide Once Weekly With SU Use at ScreeningMajor Hypoglycemia	0.00	—
Minor Hypoglycemia	0.76	—
Liraglutide Once Daily With SU Use at ScreeningMajor Hypoglycemia	0.00	—
Minor Hypoglycemia	0.55	—
Exenatide Once Weekly Without SU Use at ScreeningMajor Hypoglycemia	0.00	—
Minor Hypoglycemia	0.67	—
Liraglutide Once Daily Without SU Use at ScreeningMajor Hypoglycemia	0.00	—
Minor Hypoglycemia	0.05	—

Secondary/protocol endpoint

Assessment of Event Rate of Treatment-emergent Hypoglycemic Events

Time frame:Baseline to Week 26

Documented hypoglycemia

event count, event

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

Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials.
Postgraduate medicine2013 May (month)PMID23748506doi:10.3810/pgm.2013.05.2660via clinicaltrials gov reference derived + pubmed nct search
Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study.
Lancet (London, England)2013 Jan 12PMID23141817doi:10.1016/S0140-6736(12)61267-7via 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.