NCT01505426 is a Phase 3 clinical trial of ASP1941 in Type II Diabetes Mellitus, sponsored by Astellas Pharma Inc.

Who is sponsoring NCT01505426?

NCT01505426 is sponsored by Astellas Pharma Inc.

What drugs are being tested in NCT01505426?

Interventions in NCT01505426: ASP1941, metformin, Placebo.

What condition does NCT01505426 study?

NCT01505426 studies Type II Diabetes Mellitus.

Is NCT01505426 still recruiting?

NCT01505426 is currently completed. Last updated 12 November 2024.

Last reviewed 2024-11-12 · How we verify

NCT01505426

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

A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients

Completed Phase 3 Last updated 12 November 2024

What this trial tests

Phase 3 trial testing ASP1941 in Type II Diabetes Mellitus in 171 participants. Completed in 14 January 2013.

Timeline

28 November 2011

Primary endpoint
14 January 2013

14 January 2013

Quick facts

Lead sponsor	Astellas Pharma Inc
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	171
Start date	28 November 2011
Primary completion	14 January 2013
Estimated completion	14 January 2013
Sites	12 locations across Taiwan, South Korea

Drugs / interventions tested

ASP1941 — full drug profile →
metformin (metformin) — full drug profile →
Placebo

Conditions studied

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

Sponsor

Astellas Pharma Inc — full company profile →

Who can join

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

Sponsor's own description

To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian subjects with type 2 diabetes mellitus.

Publications & conference data

8 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
Efficacy, safety, and tolerability of ipragliflozin in Asian patients with type 2 diabetes mellitus and inadequate glycemic control with metformin: Results of a phase 3 randomized, placebo-controlled, double-blind, multicenter trial.
Lu CH, Min KW, Chuang LM, Kokubo S, et al · · 2016 · cited 52× · PMID 27330723 · DOI 10.1111/jdi.12422
Comparative Effects of Sodium-Glucose Cotransporter 2 Inhibitors on Serum Electrolyte Levels in Patients with Type 2 Diabetes: A Pairwise and Network Meta-Analysis of Randomized Controlled Trials.
Zhang J, Huan Y, Leibensperger M, Leibensperger M, et al · · 2022 · cited 30× · PMID 35582188 · DOI 10.34067/kid.0006672021
Addition of Ipragliflozin to Metformin Treatment in Korean Patients with Type 2 Diabetes Mellitus: Subgroup Analysis of a Phase 3 Trial.
Min KW, Ku BJ, Lee JH, Kim MS, et al · · 2017 · cited 13× · PMID 28447440 · DOI 10.4093/dmj.2017.41.2.135
Profile of Ipragliflozin, an Oral SGLT-2 Inhibitor for the Treatment of Type 2 Diabetes: The Evidence to Date.
Alkabbani W, Gamble JM. · · 2021 · cited 11× · PMID 34285473 · DOI 10.2147/dddt.s281602
Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials.
Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, et al · · 2019 · cited 10× · PMID 31606880 · DOI 10.1007/s13300-019-00699-8
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
Comparative efficacy and safety of sodium-glucose cotransporter 2 inhibitors for renal outcomes in patients with type 2 diabetes mellitus: a systematic review and network meta-analysis.
Ma J, Lu J, Shen P, Zhao X, et al · · 2023 · cited 4× · PMID 37724571 · DOI 10.1080/0886022x.2023.2222847

Verify or expand the search:

Other trials of ASP1941

Trials testing the same drug.

NCT02529449 — Pharmacodynamics, Pharmacokinetics, and Safety of ASP1941 in Patients With Type 1 Diabetes Mellitus · Phase 2 · completed
NCT02452632 — A Study to Assess the Efficacy and Safety of ASP1941 in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glyce · Phase 3 · completed
NCT01514838 — A Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus · Phase 3 · terminated
NCT01611363 — A Phase 1 Study to Investigate the Mechanism of Action of Ipragliflozin · Phase 1 · completed
NCT01316094 — A Study to Assess Efficacy and Safety of ASP1941 in Diabetic Patients With Renal Impairment · Phase 3 · completed

Other recruiting trials for Type II Diabetes Mellitus

Currently open trials in the same condition.

NCT07495956 — cfMSC Therapy for Diabetes · Phase 1, PHASE2 · recruiting
NCT07340320 — A Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus · Phase 2 · recruiting
NCT06561126 — Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its · NA · recruiting
NCT07350694 — Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its · NA · recruiting
NCT06387550 — Effects of Eccentric Training on Glycemic Control and Quality of Life in Patients With Type II Diabetes Mellitus · NA · recruiting

Other Astellas Pharma Inc trials

Trials by the same sponsor.

NCT07318714 — A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke · Phase 1, PHASE2 · recruiting
NCT07094204 — A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors · Phase 1 · recruiting
NCT06970665 — A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Ma · Phase 4 · recruiting
NCT06364696 — A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors · Phase 1 · active not recruiting
NCT06206421 — A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause · Phase 3 · completed

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 NCT01505426 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Astellas Pharma Inc
Last refreshed: 12 November 2024

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/NCT01505426.

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