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

A Phase 3 Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01135433
Enrollment
168
Registered
2010-06-02
Start date
2010-05-15
Completion date
2011-11-28
Last updated
2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes mellitus, Metformin, ASP1941

Brief summary

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

Detailed description

This study is to evaluate the efficacy (HbA1c change from baseline) and safety of ASP1941 in combination with metformin in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with metformin alone. The effects of ASP1941 are compared with those of placebo.

Interventions

DRUGipragliflozin

oral

DRUGPlacebo

oral

DRUGmetformin

oral

Sponsors

Astellas Pharma Inc
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Change from baseline in HbA1cBaseline and for 24 weeks

Secondary

MeasureTime frame
Change from baseline in fasting plasma glucoseBaseline and for 24 weeks
Change from baseline in fasting serum insulinBaseline 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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026