NCT00641056 is a Phase 3 clinical trial of Exenatide Once Weekly in Type 2 Diabetes Mellitus, sponsored by AstraZeneca.

Who is sponsoring NCT00641056?

NCT00641056 is sponsored by AstraZeneca.

What drugs are being tested in NCT00641056?

Interventions in NCT00641056: Exenatide Once Weekly, Insulin Glargine.

What condition does NCT00641056 study?

NCT00641056 studies Type 2 Diabetes Mellitus.

Is NCT00641056 still recruiting?

NCT00641056 is currently completed. Last updated 21 May 2015.

Are results published for NCT00641056?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2015-05-21 · How we verify

NCT00641056

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy of Once-Weekly Exenatide Long-Acting Release and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea

Completed Phase 3 Results posted Last updated 21 May 2015

What this trial tests

Phase 3 trial testing Exenatide Once Weekly in Type 2 Diabetes Mellitus in 467 participants. Completed in 1 November 2009.

Timeline

1 April 2008

Primary endpoint
1 May 2009

1 November 2009

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	467
Start date	1 April 2008
Primary completion	1 May 2009
Estimated completion	1 November 2009
Sites	75 locations across United States, Australia, Belgium, Czechia, Denmark, France, Germany, Greece

Drugs / interventions tested

Exenatide Once Weekly — full drug profile →
Insulin Glargine (INSULIN GLARGINE) — full drug profile →

Conditions studied

Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

AstraZeneca — full company profile →

Who can join

18 and older, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change in HbA1c From Baseline to Week 26
Time frame: Baseline, Week 26
Change in HbA1c from baseline to Week 26

Sponsor's own description

The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen et al.(2007), with respect to glycemic improvements, body weight, fasting lipids, safety, and tolerability.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial.
Diamant M, Van Gaal L, Stranks S, Northrup J, et al · · 2010 · cited 335× · PMID 20609969 · DOI 10.1016/s0140-6736(10)60406-0
Long-acting glucagon-like peptide 1 receptor agonists: a review of their efficacy and tolerability.
Garber AJ. · · 2011 · cited 233× · PMID 21525469 · DOI 10.2337/dc11-s231
Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3-year results of an open-label randomised trial.
Diamant M, Van Gaal L, Guerci B, Stranks S, et al · · 2014 · cited 131× · PMID 24731672 · DOI 10.1016/s2213-8587(14)70029-4
Glucagon-like peptide analogues for type 2 diabetes mellitus.
Shyangdan DS, Royle P, Clar C, Sharma P, et al · · 2011 · cited 123× · PMID 21975753 · DOI 10.1002/14651858.cd006423.pub2
Glucagon-like peptide-1 receptor agonists and cardiovascular events: a meta-analysis of randomized clinical trials.
Monami M, Cremasco F, Lamanna C, Colombi C, et al · · 2011 · cited 76× · PMID 21584276 · DOI 10.1155/2011/215764
Glucagon-like peptide-1 receptor agonists: a systematic review of comparative effectiveness research.
Levin PA, Nguyen H, Wittbrodt ET, Kim SC. · · 2017 · cited 72× · PMID 28435305 · DOI 10.2147/dmso.s130834
Safety and efficacy of once-weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes over 84 weeks.
Diamant M, Van Gaal L, Stranks S, Guerci B, et al · · 2012 · cited 69× · PMID 22357185 · DOI 10.2337/dc11-1233
Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials.
Grimm M, Han J, Weaver C, Griffin P, et al · · 2013 · cited 51× · PMID 23748506 · DOI 10.3810/pgm.2013.05.2660

Verify or expand the search:

Other trials of Exenatide Once Weekly

Trials testing the same drug.

NCT01554618 — Safety and Efficacy Study of Exenatide Once Weekly in Adolescents With Type 2 Diabetes · Phase 3 · completed
NCT01144338 — Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treat · Phase 3 · completed

Other recruiting trials for Type 2 Diabetes Mellitus

Currently open trials in the same condition.

NCT07351058 — A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes · Phase 3 · recruiting
NCT07373938 — Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus · recruiting
NCT07433062 — A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With · Phase 1 · recruiting
NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes · NA · active not recruiting
NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic · recruiting

Other AstraZeneca trials

Trials by the same sponsor.

NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00641056 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 21 May 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00641056.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing