NCT02175784 is a Phase 4 clinical trial of ipragliflozin in Type 2 Diabetes Mellitus, sponsored by Astellas Pharma Inc.

Who is sponsoring NCT02175784?

NCT02175784 is sponsored by Astellas Pharma Inc.

What drugs are being tested in NCT02175784?

Interventions in NCT02175784: ipragliflozin, placebo.

What condition does NCT02175784 study?

NCT02175784 studies Type 2 Diabetes Mellitus.

Is NCT02175784 still recruiting?

NCT02175784 is currently completed. Last updated 8 November 2024.

Last reviewed 2024-11-08 · How we verify

NCT02175784

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 Ipragliflozin in Combination With Insulin in Subjects With Type 2 Diabetes Mellitus

Completed Phase 4 Last updated 8 November 2024

What this trial tests

Phase 4 trial testing ipragliflozin in Type 2 Diabetes Mellitus in 262 participants. Completed in 7 December 2015.

Timeline

31 March 2014

Primary endpoint
31 March 2015

7 December 2015

Quick facts

Lead sponsor	Astellas Pharma Inc
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	262
Start date	31 March 2014
Primary completion	31 March 2015
Estimated completion	7 December 2015
Sites	8 locations across Japan

Drugs / interventions tested

ipragliflozin (IPRAGLIFLOZIN) — full drug profile →
placebo

Conditions studied

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

Sponsor

Astellas Pharma Inc — full company profile →

Who can join

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

Sponsor's own description

The purpose of this study is to assess the efficacy (superiority to placebo) of ipragliflozin based on the changes in HbA1C, as well as its safety, in patients with type 2 diabetes mellitus in combination with an insulin preparation once daily for 16 weeks. The long-term (52 weeks) safety and the persistence of the efficacy will also be evaluated.

Publications & conference data

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

SLC transporters as therapeutic targets: emerging opportunities.
Lin L, Yee SW, Kim RB, Giacomini KM. · · 2015 · cited 653× · PMID 26111766 · DOI 10.1038/nrd4626
Efficacy and safety of ipragliflozin as add-on therapy to insulin in Japanese patients with type 2 diabetes mellitus (IOLITE): a multi-centre, randomized, placebo-controlled, double-blind study.
Ishihara H, Yamaguchi S, Nakao I, Okitsu A, et al · · 2016 · cited 39× · PMID 27436788 · DOI 10.1111/dom.12745
Risk of hypovolemia associated with sodium-glucose cotransporter-2 inhibitors treatment: A meta-analysis of randomized controlled trials.
Rong X, Zhu Y, Wen B, Liu K, et al · · 2022 · cited 14× · PMID 36451919 · DOI 10.3389/fcvm.2022.973129
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
Efficacy and safety of ipragliflozin as add-on therapy to insulin in Japanese patients with type 2 diabetes mellitus (IOLITE): a 36-week, open-label extension of a 16-week, randomized, placebo-controlled, double-blind study.
Ishihara H, Yamaguchi S, Nakao I, Asahina S, et al · · 2019 · cited 4× · PMID 30800562 · DOI 10.1007/s13340-018-0359-x

Verify or expand the search:

Other trials of ipragliflozin

Trials testing the same drug.

NCT03118713 — A Study to Evaluate the Renal Protective Effect (Urine Albumin-to-Creatinine Ratio (UACR)), Efficacy and Safety of Iprag · Phase 4 · terminated
NCT02897219 — A Study of ASP1941 in Combination With Insulin in Patients With Type 1 Diabetes Mellitus · Phase 3 · completed
NCT02479399 — Specified Drug Use Results Survey of Ipragliflozin Treatment in type2 Diabetes Patients · completed
NCT01672762 — A Study to Evaluate Long-term Safety and Efficacy of ASP1941 in Diabetes Patients · Phase 3 · completed
NCT01316107 — A Study to Assess Safety and Efficacy of ASP1941 in Combination With Nateglinide in Type 2 Diabetic Patients · 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 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 NCT02175784 (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 Astellas Pharma Inc
Last refreshed: 8 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/NCT02175784.

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