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A Study to Assess the Efficacy and Safety of ASP1941 in Japanese Type 2 Diabetes Patients

Phase III Study of ASP1941 -A Phase III, Randomized, Double-Blind, Placebo-controlled, Monotherapy Study to Assess the Efficacy, Safety, and Tolerability of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01057628
Enrollment
130
Registered
2010-01-27
Start date
2010-01-13
Completion date
2010-11-06
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

Blood glucose, ASP1941, Diabetes mellitus

Brief summary

This study is to compare the efficacy and safety of ASP1941 with placebo in Japanese patients with type 2 diabetes mellitus.

Interventions

DRUGipragliflozin

oral

DRUGplacebo

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 for at least 12 weeks * HbA1c value between 7.0 and 10.0% * Body Mass Index (BMI) 20.0 - 45.0 kg/m2 * Investigator adjudicates that a subject is able to discontinue currently taking hypoglycemic agents safely during treatment

Exclusion criteria

* Type 1 diabetes mellitus patients * Serum creatinine \> upper limit of normal * 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 HbA1c16 weeks

Secondary

MeasureTime frame
change from baseline in fasting plasma glucose16 weeks
change from baseline in fasting serum insulin16 weeks
safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)During treatment

Countries

Japan

Outcome results

None listed

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