NCT00637273 is a Phase 3 clinical trial of exenatide once weekly in Type 2 Diabetes Mellitus, sponsored by AstraZeneca.

Who is sponsoring NCT00637273?

NCT00637273 is sponsored by AstraZeneca.

What drugs are being tested in NCT00637273?

Interventions in NCT00637273: exenatide once weekly, sitagliptin, pioglitazone, placebo tablet, placebo once weekly.

What condition does NCT00637273 study?

NCT00637273 studies Type 2 Diabetes Mellitus.

Is NCT00637273 still recruiting?

NCT00637273 is currently completed. Last updated 19 March 2015.

Are results published for NCT00637273?

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

Last reviewed 2015-03-19 · How we verify

NCT00637273

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

A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Long-Acting Release(Once Weekly) to Those of Sitagliptin and a Thiazolidinedione in Subjects With Type 2 Diabetes Mellitus Treated With Metformin

Completed Phase 3 Results posted Last updated 19 March 2015

What this trial tests

Phase 3 trial testing exenatide once weekly in Type 2 Diabetes Mellitus in 514 participants. Completed in 1 July 2009.

Timeline

1 January 2008

Primary endpoint
1 February 2009

1 July 2009

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	514
Start date	1 January 2008
Primary completion	1 February 2009
Estimated completion	1 July 2009
Sites	62 locations across United States, India, Mexico

Drugs / interventions tested

exenatide once weekly — full drug profile →
sitagliptin (SITAGLIPTIN) — full drug profile →
pioglitazone (pioglitazone) — full drug profile →
placebo tablet
placebo once weekly — 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: Day 1, Week 26
Absolute change in HbA1c from baseline (Day 1) to Week 26 \[Week 26 - Baseline\].

Sponsor's own description

This study will compare the benefits of exenatide once weekly treatment to those achieved by the approved antidiabetic therapies sitagliptin and pioglitazone in subjects whose type 2 diabetes is managed with metformin therapy alone. The safety and tolerability of the three treatment regimens will also be compared.

Publications & conference data

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

Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial.
Bergenstal RM, Wysham C, Macconell L, Malloy J, et al · · 2010 · cited 444× · PMID 20580422 · DOI 10.1016/s0140-6736(10)60590-9
Comparative effectiveness of dipeptidylpeptidase-4 inhibitors in type 2 diabetes: a systematic review and mixed treatment comparison.
Craddy P, Palin HJ, Johnson KI. · · 2014 · cited 85× · PMID 24664619 · DOI 10.1007/s13300-014-0061-3
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
Use of GLP-1 Receptor Agonists and Occurrence of Thyroid Disorders: a Meta-Analysis of Randomized Controlled Trials.
Hu W, Song R, Cheng R, Liu C, et al · · 2022 · cited 72× · PMID 35898463 · DOI 10.3389/fendo.2022.927859
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
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
Dipeptidyl peptidase-4 inhibitors and cancer risk in patients with type 2 diabetes: a meta-analysis of randomized clinical trials.
Zhao M, Chen J, Yuan Y, Zou Z, et al · · 2017 · cited 50× · PMID 28811622 · DOI 10.1038/s41598-017-07921-2
An overview on medicinal perspective of thiazolidine-2,4-dione: A remarkable scaffold in the treatment of type 2 diabetes.
Bansal G, Thanikachalam PV, Maurya RK, Chawla P, et al · · 2020 · cited 49× · PMID 32154036 · DOI 10.1016/j.jare.2020.01.008

Verify or expand the search:

Other trials of exenatide once weekly

Trials testing the same drug.

NCT02917057 — Subanalyses of Elderly Type 2 Diabetes Patients or Type 2 Diabetes Patients With Renal Impairment · completed
NCT02987348 — Clinical Outcomes of Exenatide Versus Basal Insulin · completed
NCT02974244 — Comparison of the Effectiveness and Tolerability of Exenatide Once-weekly Compared to Basal Insulins · 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 NCT00637273 (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: 19 March 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/NCT00637273.

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