Skip to main content
OpenTrials
Completed

NCT Number: NCT01057628

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hokkaido, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ipragliflozin

Drug

oral

Other names: ASP1941

Placebo

Drug

oral

Primary outcomes

  1. change from baseline in HbA1c

    Time frame: 16 weeks

Secondary outcomes

  1. change from baseline in fasting plasma glucose

    Time frame: 16 weeks

  2. change from baseline in fasting serum insulin

    Time frame: 16 weeks

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

    Time frame: During treatment

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 27, 2010
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.