A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Type 2 Diabetic Patients

NCT01135433 | Completed Phase 3

• 1 other identifier: 1941-CL-0106
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 7

Brief Summary

This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and metformin in patients with diabetes mellitus.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes mellitus; Metformin; ASP1941

Outcome Measures

Primary Outcomes (1)

• Change from baseline in HbA1c

  Baseline and for 24 weeks

Secondary Outcomes (3)

• Change from baseline in fasting plasma glucose

  Baseline and for 24 weeks

• Change from baseline in fasting serum insulin

  Baseline and for 24 weeks

• Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)

  for 52 weeks

Study Arms (2)

ASP group

EXPERIMENTAL

ASP1941 and metformin

Drug: ipragliflozin; Drug: metformin

Placebo group

PLACEBO COMPARATOR

placebo and metformin

Drug: Placebo; Drug: metformin

Interventions

ipragliflozin DRUG

oral

Also known as: ASP1941

ASP group

Placebo DRUG

oral

Placebo group

metformin DRUG

oral

Also known as: Metgluco, Melbin, Glycoran

ASP group; Placebo group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetic patients receiving with metformin mono-therapy for at least 6 weeks
• HbA1c value between 7.0 and 9.5%
• Body Mass Index (BMI) 20.0 - 45.0 kg/m2

You may not qualify if:

• Type 1 diabetes mellitus patients
• Serum creatinine \> upper limit of normal
• Estimated GFR \< 60ml/min/1.73m2
• Proteinuria (albumin/creatinine ratio \> 300mg/g)
• Dysuria and/or urinary tract infection, genital infection
• Significant renal, hepatic or cardiovascular diseases
• Severe gastrointestinal diseases

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (7)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

Related Publications (1)

• Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12.

  PMID: 31606880 DERIVED

Related Links

• Link to results on Astellas Clinical Study Results website

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

ipragliflozin; Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2010
• First Posted: June 2, 2010
• Study Start: May 15, 2010
• Primary Completion: November 28, 2011
• Study Completion: November 28, 2011
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (7)