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NCT01057628 Clinical Trial

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

Type 2 Diabetes Mellitus Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01057628
Other study ID # 1941-CL-0105
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 13, 2010
Est. completion date November 6, 2010

Study information
Verified date May 2019
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date November 6, 2010
Est. primary completion date November 6, 2010
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ipragliflozin
oral
• placebo
oral

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary change from baseline in HbA1c 16 weeks
Secondary change from baseline in fasting plasma glucose 16 weeks
Secondary change from baseline in fasting serum insulin 16 weeks
Secondary safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs) During treatment
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