A Study to Assess the Long-term Safety and Efficacy of ASP1941 in Japanese Diabetic Patients

Long-term Study of ASP1941 - A Phase III, Open-Label, Uncontrolled, Monotherapy Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01054092

Enrollment

182

Registered

2010-01-22

Start date

2010-01-14

Completion date

2011-07-22

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, Food effect, Diabetes mellitus

Brief summary

The primary objective of this study is to evaluate the long-term safety of ASP1941 in patients with type 2 diabetes mellitus. The second objectives are to compare the efficacy and pharmacokinetics of ASP1941 administered before or after food intake.

Detailed description

Subject will be randomized into either ASP1941 before meal or ASP1941 after meal groups. Subjects will undergo a screening period before entering the long-term treatment. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.

Interventions

DRUGipragliflozin

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Type 2 diabetic patients for at least 12 weeks * HbA1c value between 6.5 and 9.5% * Body Mass Index ( BMI )20.0 - 45.0kg/m2

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 * Proliferative diabetic retinopathy

Design outcomes

Primary

Measure	Time frame
HbA1c	For 52 weeks

Secondary

Measure	Time frame
Fasting plasma glucose	For 52 weeks
Fasting serum insulin	For 52 weeks
Plasma levels of ASP1941 for population PK analysis	For 52 weeks
Safety assessed by adverse events, vital signs laboratory tests and 12-lead ECGs	For 52 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026