NCT01217892 is a Phase 3 clinical trial of dapagliflozin in Type 2 Diabetes, sponsored by AstraZeneca.

Who is sponsoring NCT01217892?

NCT01217892 is sponsored by AstraZeneca.

What drugs are being tested in NCT01217892?

Interventions in NCT01217892: dapagliflozin, dapagliflozin, dapagliflozin, metformin, placebo.

What condition does NCT01217892 study?

NCT01217892 studies Type 2 Diabetes.

Is NCT01217892 still recruiting?

NCT01217892 is currently completed. Last updated 16 October 2014.

Are results published for NCT01217892?

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

Last reviewed 2014-10-16 · How we verify

NCT01217892

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

A 16-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of Dapagliflozin 2.5 mg BID, 5 mg BID and 10 mg QD Versus Placebo in Patients With Type 2 Diabetes Who Are Inadequately Controlled on Metformin-IR Monotherapy

Completed Phase 3 Results posted Last updated 16 October 2014

What this trial tests

Phase 3 trial testing dapagliflozin in Type 2 Diabetes in 400 participants. Completed in 1 August 2011.

Timeline

1 November 2010

Primary endpoint
1 August 2011

1 August 2011

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	400
Start date	1 November 2010
Primary completion	1 August 2011
Estimated completion	1 August 2011
Sites	55 locations across Germany, Hungary, Romania, Slovakia, South Africa, Switzerland, Ukraine

Drugs / interventions tested

dapagliflozin (DAPAGLIFLOZIN) — full drug profile →
dapagliflozin (DAPAGLIFLOZIN) — full drug profile →
dapagliflozin (DAPAGLIFLOZIN) — full drug profile →
metformin (metformin) — full drug profile →
placebo

Conditions studied

Type 2 Diabetes — all drugs for Type 2 Diabetes →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 77, any sex, with Type 2 Diabetes. 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.

Adjusted Mean Change in HbA1c Levels
Time frame: Baseline to Week 16
To compare the change from baseline in HbA1c achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.

Sponsor's own description

This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5 mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is beneficial in diabetes treatment, and if so, how it compares to treatment with metformin alone.

Publications & conference data

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

Update on developments with SGLT2 inhibitors in the management of type 2 diabetes.
Nauck MA. · · 2014 · cited 227× · PMID 25246775 · DOI 10.2147/dddt.s50773
Dapagliflozin in patients with type 2 diabetes mellitus: A pooled analysis of safety data from phase IIb/III clinical trials.
Jabbour S, Seufert J, Scheen A, Bailey CJ, et al · · 2018 · cited 114× · PMID 28950419 · DOI 10.1111/dom.13124
Effects of sodium-glucose cotransporter 2 inhibitors on bone metabolism in patients with type 2 diabetes mellitus: a systematic review and meta-analysis.
Wang J, Li X, Li Y, Lei C. · · 2024 · cited 9× · PMID 38658986 · DOI 10.1186/s12902-024-01575-8
Serum uric acid reduction through SGLT2 inhibitors: evidence from a systematic review and meta-analysis.
Yang S, Hu Q, Liu K, Xiao B, et al · · 2025 · cited 3× · PMID 40612743 · DOI 10.3389/fphar.2025.1551390
Comparison of effectiveness and safety of bexagliflozin and other sodium-glucose cotransporter 2 inhibitors for type 2 diabetes mellitus in adults: systematic review and network meta-analysis of randomized controlled trials.
Gao S, Zhang F, Xie X, Fan L. · · 2026 · PMID 42211460 · DOI 10.3389/fendo.2026.1843370

Verify or expand the search:

Other trials of dapagliflozin

Trials testing the same drug.

NCT06532682 — Efficacy of Dapagliflozin in Early Diabetic Nephropathy in Type 1 Diabetes · Phase 4 · active not recruiting
NCT05848102 — Dapagliflozin Effect on FunctiOnal Mitral Regurgitation and Myocardial Fibrosis (DEFORM) · Phase 4 · unknown
NCT05748925 — Cardio Renal Effects of SGLT2 Inhibitors Among Lupus Nephritis Patients · Phase 4 · completed
NCT04792190 — Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atr · Phase 4 · completed
NCT03782259 — Effects of SGLT-2 Inhibition on Myocardial Fibrosis and Inflammation as Assessed by Cardiac MRI in Patients With DM2 · Phase 4 · completed

Other recruiting trials for Type 2 Diabetes

Currently open trials in the same condition.

NCT07053319 — SGLT2i, Pioglitazone, and Ketone Production in T2D · Phase 1 · recruiting
NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
NCT07463859 — Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabet · NA · recruiting
NCT07254689 — The Food for Health Study · NA · recruiting
NCT07558863 — Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes · Phase 4 · 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 NCT01217892 (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: 16 October 2014

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/NCT01217892.

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