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NCT Number: NCT01054092

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

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.

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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

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.

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 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

Treatment and study plan

Ipragliflozin

Drug

oral

Other names: ASP1941

Primary outcomes

  1. HbA1c

    Time frame: For 52 weeks

Secondary outcomes

  1. Fasting plasma glucose

    Time frame: For 52 weeks

  2. Fasting serum insulin

    Time frame: For 52 weeks

  3. Plasma levels of ASP1941 for population PK analysis

    Time frame: For 52 weeks

  4. Safety assessed by adverse events, vital signs laboratory tests and 12-lead ECGs

    Time frame: For 52 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 22, 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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