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NCT01117584: BALANCE
A Study to Evaluate the Effect of ASP1941 in Combination With Metformin in Adult Patients With Type 2 Diabetes Mellitus
Phase 2 trial testing ipragliflozin in Type 2 Diabetes Mellitus in 343 participants. Completed in 1 April 2011.
1 April 2011
Quick facts
| Lead sponsor | Astellas Pharma Inc |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 343 |
| Start date | 6 April 2010 |
| Primary completion | 1 April 2011 |
| Estimated completion | 1 April 2011 |
| Sites | 44 locations across Italy, United Kingdom, Poland, Hungary, Romania, United States |
Drugs / interventions tested
- ipragliflozin (IPRAGLIFLOZIN) — full drug profile →
- Placebo
- Metformin (metformin) — full drug profile →
Conditions studied
- Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →
Sponsor
Astellas Pharma Inc — 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.
Sponsor's own description
Evaluate the efficacy, safety and tolerability of a 12-week treatment of 4 doses of ASP1941 compared to placebo in combination with metformin in adult patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on 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 -
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 -
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 -
The variability in beta-cell function in placebo-treated subjects with type 2 diabetes: application of the weight-HbA1c-insulin-glucose (WHIG) model.
Duong JK, de Winter W, Choy S, Plock N, et al · · 2017 · cited 3× · PMID 27679422 · DOI 10.1111/bcp.13144
Verify or expand the search:
- PubMed search for NCT01117584
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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
- NCT02175784 — A Study to Assess the Efficacy and Safety of Ipragliflozin in Combination With Insulin in Subjects With Type 2 Diabetes · Phase 4 · completed
- NCT01672762 — A Study to Evaluate Long-term Safety and Efficacy of ASP1941 in Diabetes 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)
- Trial protocol + status: ClinicalTrials.gov NCT01117584 (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: 22 May 2025
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/NCT01117584.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing