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NCT Number: NCT01135433

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

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

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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

Chugoku, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ipragliflozin

Drug

oral

Other names: ASP1941

Placebo

Drug

oral

metformin

Drug

oral

Other names: Metgluco, Melbin, Glycoran

Primary outcomes

  1. Change from baseline in HbA1c

    Time frame: Baseline and for 24 weeks

Secondary outcomes

  1. Change from baseline in fasting plasma glucose

    Time frame: Baseline and for 24 weeks

  2. Change from baseline in fasting serum insulin

    Time frame: Baseline and for 24 weeks

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

    Time frame: for 52 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 2, 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.

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