GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)

A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release on Glucose Control (HbA1c) and Safety in Subjects With Type 2 Diabetes Mellitus Managed With Diet Modification and Exercise and/or Oral Antidiabetic Medications

Lead sponsor

AstraZeneca

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

303

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 25-45•HbA1c 7.1-11%

Primary endpoints

•HbA1c, change•Plasma concentration (steady state)

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 IDNCT00308139

Org study ID2993LAR-105 (DURATION - 1)

Secondary IDMB001-010Bristol Myers Squibb

Timeline

Milestones

Study first posted2006-03-29estimated

Results first posted2012-08-17estimated

Last update posted2015-08-26estimated

Study start2006-04 (month precision)

Primary completion2008-07actual (month precision)

Study completion2014-08actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age16 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Has type 2 diabetes mellitus treated with diet modification and exercise alone or in combination with a stable regimen of a combination of metformin, sulphonylureas, and thiazolidinediones for a minimum of 2 months at screening.

•Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.

•Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.

•(For sub-study) Currently participating in open ended assessment period of main study 2993 LAR105

Exclusion criteria

•Has been previously exposed to exenatide (Byetta®), exenatide LAR, or any glucagon-like peptide-1 (GLP-1) analog.

•Received any investigational drug or has participated in any type of clinical trial within 30 days prior to screening.

•Has been treated, is currently treated, or is expected to require or undergo treatment with any of the following excluded medications:

–Alpha glucosidase inhibitor or meglitinide within 30 days of screening;

–Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;

–Regular use (> 14 days) of drugs that directly affect gastrointestinal motility;

–Regular use (> 14 days) of systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption;

–Regular use (> 14 days) of medications with addictive potential such as opiates and opioids;

–Prescription or over-the-counter weight loss medications within 6 months of screening.

•(For sub-study) Subjects will be terminated from study who do not participate in the dual chamber pen substudy

Endpoints (26)

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

Cardiometabolic biomarkers

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change in Body Weight From Baseline to Week 30

Time frame:Day -3, Week 30

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Exenatide Once Weekly	-3.67	-4.59 – -2.75
Exenatide Twice Daily	-3.59	-4.51 – -2.67

Least Squares Mean Difference-0.0895% CI-1.29 – 1.12p0.8916ANCOVA

Secondary/protocol endpoint

Change in Body Weight From Baseline to Week 364

Time frame:Day -3, Week 364

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Exenatide Once Weekly -> Exenatide Once Weekly	-5.25	-7.23 – -3.27
Exenatide Twice Daily -> Exenatide Once Weekly	-2.71	-4.55 – -0.87
All Treatment	-3.87	-5.36 – -2.37

Glycemic / diabetes

10 endpoints

Primary/protocol endpoint

Change in HbA1c From Baseline to Week 30

Time frame:Day -3, Week 30

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	-1.87	-2.03 – -1.71
Exenatide Twice Daily	-1.54	-1.70 – -1.38

Least Squares Mean Difference-0.3395% CI-0.54 – -0.12p0.0023ANOVA

Secondary/protocol endpoint

Change in HbA1c From Baseline to Week 364

Time frame:Day -3, Week 364

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 -> Exenatide Once Weekly	-1.49	-1.80 – -1.19
Exenatide Twice Daily -> Exenatide Once Weekly	-1.57	-1.85 – -1.28
All Treatment	-1.53	-1.76 – -1.31

Secondary/protocol endpoint

Percentage of Subjects Achieving HbA1c Target of <7%

Time frame:Week 30

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Exenatide Once Weekly	70.9	—
Exenatide Twice Daily	51.0	—

p0.0003Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Percentage of Subjects Achieving HbA1c Target of <7%

Time frame:Week 364

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Exenatide Once Weekly -> Exenatide Once Weekly	41.4	—
Exenatide Twice Daily -> Exenatide Once Weekly	50.0	—
All Treatment	45.9	—

Secondary/protocol endpoint

Percentage of Subjects Achieving HbA1c Target of <=6.5%

Time frame:Week 30

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Exenatide Once Weekly	3.0	—
Exenatide Twice Daily	16.3	—

p0.2042Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Percentage of Subjects Achieving HbA1c Target of <=6.5%

Time frame:Week 364

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Exenatide Once Weekly -> Exenatide Once Weekly	22.4	—
Exenatide Twice Daily -> Exenatide Once Weekly	37.5	—
All Treatmeat	30.3	—

Secondary/protocol endpoint

Percentage of Subjects Achieving HbA1c Target of <=6.0%

Time frame:Week 30

HbA1c <6.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Exenatide Once Weekly	23.0	—
Exenatide Twice Daily	16.3	—

p0.1513Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Change in 2 Hours (2h) Postprandial Glucose From Baseline to Week 14

Time frame:Day -3, Week 14

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Exenatide Once Weekly	-95.88	-112.92 – -78.83
Exenatide Twice Daily	-125.96	-142.74 – -109.17

Least Squares Mean Difference30.0895% CI6.88 – 53.28p0.0124ANCOVA

Secondary/protocol endpoint

Change in Fasting Plasma Glucose From Baseline to Week 30

Time frame:Day -3, Week 30

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Exenatide Once Weekly	-41.5	-47.4 – -35.7
Exenatide Twice Daily	-24.6	-30.3 – -18.9

Least Squares Mean Difference-16.995% CI-24.4 – -9.4p<.0001ANCOVA

Secondary/protocol endpoint

Change in Fasting Plasma Glucose From Baseline to Week 364

Time frame:Day -3, Week 364

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Exenatide Once Weekly -> Exenatide Once Weekly	-18.3	-30.8 – -5.7
Exenatide Twice Daily -> Exenatide Once Weekly	-27.7	-39.0 – -16.4
All Treatment	-23.6	-33.0 – -14.2

Cardiometabolic biomarkers

9 endpoints

Secondary/protocol endpoint

Change in Blood Pressure From Baseline to Week 30

Time frame:Day -3, Week 30

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (mean), mmHg	95% CI
Exenatide Once WeeklySitting Systolic Blood Pressure	-4.4	—
Sitting Diastolic Blood Pressure	-1.1	—
Exenatide Twice DailySitting Systolic Blood Pressure	-3.8	—
Sitting Diastolic Blood Pressure	-2.3	—

Secondary/protocol endpoint

Change in Blood Pressure From Baseline to Week 364

Time frame:Day -3, Week 364

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mmHg	95% CI
Exenatide Once Weekly -> Exenatide Once WeeklySitting Systolic Blood Pressure	1.3	—
Sitting Diastolic Blood Pressure	-1.7	—
Exenatide Twice Daily -> Exenatide Once WeeklyEditSitting Systolic Blood Pressure	1.0	—
Sitting Diastolic Blood Pressure	-3.6	—
All TreatmentSitting Systolic Blood Pressure	1.2	—
Sitting Diastolic Blood Pressure	-2.7	—

Secondary/protocol endpoint

Change in Total Cholesterol From Baseline to Week 30

Time frame:Day -3, Week 30

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Exenatide Once Weekly	-11.9	-16.4 – -7.4
Exenatide Twice Daily	-3.8	-8.4 – 0.8

Least Squares Mean Difference-8.295% CI-14.1 – -2.2p0.0077ANCOVA

Secondary/protocol endpoint

Change in Total Cholesterol From Baseline to Week 364

Time frame:Day -3, Week 364

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Exenatide Once Weekly -> Exenatide Once Weekly	-15.0	-23.6 – -6.4
Exenatide Twice Daily -> Exenatide Once Weekly	-4.8	-13.0 – 3.3
All Treatment	-9.6	-16.2 – -3.0

Secondary/protocol endpoint

Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 30

Time frame:Day -3, Week 30

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Exenatide Once Weekly	-0.9	-2.0 – 0.2
Exenatide Twice Daily	-1.3	-2.5 – -0.2

Least Squares Mean Difference0.495% CI-1.0 – 1.9p0.5613ANCOVA

Secondary/protocol endpoint

Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 364

Time frame:Day -3, Week 364

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Exenatide Once Weekly -> Exenatide Once Weekly	2.2	-0.2 – 4.7
Exenatide Twice Daily -> Exenatide Once Weekly	3.4	1.0 – 5.7
All Treatment	2.8	1.0 – 4.7

Secondary/protocol endpoint

Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 364

Time frame:Day -3, Week 364

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Exenatide Once Weekly -> Exenatide Once Weekly	-13.6	-21.3 – -6.0
Exenatide Twice Daily -> Exenatide Once Weekly	-7.5	-14.7 – -0.3
All Treatment	-10.4	-16.2 – -4.6

Secondary/protocol endpoint

Ratio of Triglycerides at Week 30 to Baseline

Time frame:Day -3, Week 30

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (least_squares_mean), ratio	95% CI
Exenatide Once Weekly	0.85	0.80 – 0.91
Exenatide Twice Daily	0.89	0.84 – 0.96

Geometic Least Squares Mean Ratio0.9595% CI0.87 – 1.04p0.2915ANCOVA

Secondary/protocol endpoint

Ratio of Triglycerides at Week 364 to Baseline

Time frame:Day -3, Week 364

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (least_squares_mean), ratio	95% CI
Exenatide Once Weekly -> Exenatide Once Weekly	0.91	0.80 – 1.02
Exenatide Twice Daily -> Exenatide Once Weekly	0.94	0.84 – 1.06
All Treatment	0.93	0.85 – 1.01

Safety / tolerability / PK

5 endpoints

Primary/protocol endpoint

Sub-study Relative Bioavailability of Exenatide When Administered Using the Exenatide Once Weekly Dual Chambered Pen and the Exenatide Once Weekly Single Dose Tray (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)

Time frame:Week 22

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Exenatide LAR Steady State Concentration From Week 29 to Week 30

Time frame:Week 29 to Week 30

Plasma concentration (steady state)

concentration, descriptive

Posted result

Group	Value (geometric_mean), pg/mL	95% CI
Exenatide Once Weekly	300.23	145.13 – 702.21

Secondary/protocol endpoint

Sub-study Safety and Tolerability of Exenatide When Administered Using the Once Weekly Single Dose Tray and the Once Weekly Dual (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)

Time frame:Week 22

descriptive

componentsPlasma concentration (steady state), Treatment-emergent AEs (any)

Secondary/protocol endpoint

Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With SU Use at Screening

Time frame:Day 1 to Week 364

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), events per subject-year	95% CI
Exenatide Once Weekly With SUMajor hypoglycemic events	0.00	—
Minor hypoglycemic events	0.57	—
Exenatide Twice Daily With SUMajor hypoglycemic events	0.00	—
Minor hypoglycemic events	0.38	—
Exenatide Once Weekly -> Exenatide Once Weekly With SUMajor hypoglycemic events	0.00	—
Minor hypoglycemic events	0.49	—
Exenatide Twice Daily -> Exenatide Once Weekly With SUMajor hypoglycemic events	0.00	—
Minor hypoglycemic events	0.22	—
Exenatide Once Weekly With SUMajor hypoglycemic events	0.00	—
Minor hypoglycemic events	0.36	—

Secondary/protocol endpoint

Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With Non-SU Use at Screening

Time frame:Day 1 to Week 364

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), events per subject-year	95% CI
Exenatide Once Weekly With Non-SUMajor hypoglycemic events	0.00	—
Minor hypoglycemic events	0.00	—
Exenatide Twice Daily With Non-SUMajor hypoglycemic events	0.00	—
Minor hypoglycemic events	0.02	—
Exenatide Once Weekly -> Exenatide Once Weekly With Non-SUMajor hypoglycemic events	0.00	—
Minor hypoglycemic events	0.03	—
Exenatide Twice Daily -> Exenatide Once Weekly With Non-SUMajor hypoglycemic events	0.00	—
Minor hypoglycemic events	0.06	—
Exenatide Once Weekly With Non-SUMajor hypoglycemic events	0.00	—
Minor hypoglycemic events	0.04	—

Publications (10)

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 tolerability of exenatide once weekly over 7 years in patients with type 2 diabetes: An open-label extension of the DURATION-1 study.
Journal of diabetes and its complications2019 Mar (month)PMID30600137doi:10.1016/j.jdiacomp.2018.11.012via clinicaltrials gov reference derived + pubmed nct search
Efficacy and Tolerability of Exenatide Once Weekly Over 6 Years in Patients with Type 2 Diabetes: An Uncontrolled Open-Label Extension of the DURATION-1 Study.
Diabetes technology & therapeutics2016 Nov (month)PMID27525540doi:10.1089/dia.2016.0107via clinicaltrials gov reference derived + pubmed nct search
Five-year efficacy and safety data of exenatide once weekly: long-term results from the DURATION-1 randomized clinical trial.
Mayo Clinic proceedings2015 Mar (month)PMID25744115doi:10.1016/j.mayocp.2015.01.008via clinicaltrials gov reference derived + pubmed nct search
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: sustained improvement in glycemic control and cardiometabolic measures through 3 years.
Diabetes, metabolic syndrome and obesity : targets and therapy2013 (year)PMID23358123doi:10.2147/DMSO.S35801via clinicaltrials gov reference derived + pubmed nct search
Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment.
Diabetes, obesity & metabolism2012 Jun (month)PMID22236356doi:10.1111/j.1463-1326.2012.01561.xvia clinicaltrials gov reference derived + pubmed nct search
Treatment with exenatide once weekly or twice daily for 30 weeks is associated with changes in several cardiovascular risk markers.
Vascular health and risk management2012 (year)PMID23166441doi:10.2147/VHRM.S37969via clinicaltrials gov reference derived + pubmed nct search
Exenatide once weekly treatment maintained improvements in glycemic control and weight loss over 2 years.
BMC endocrine disorders2011 Apr 29PMID21529363doi:10.1186/1472-6823-11-9via clinicaltrials gov reference derived + pubmed nct search
DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks.
Diabetes care2010 Jun (month)PMID20215461doi:10.2337/dc09-1914via clinicaltrials gov reference derived + pubmed nct search
Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study.
Lancet (London, England)2008 Oct 4PMID18782641doi:10.1016/S0140-6736(08)61206-4via 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.