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NCT Number: NCT01023945

A Study of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

The primary purpose of this study is to evaluate the pharmacodynamic profile (blood glucose and urinary glucose excursion) of ASP1941 in patients with type 2 diabetes mellitus. Safety, tolerability and pharmacokinetics are also evaluated.

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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–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kantou, Japan

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% at screening
  • Fasting plasma glucose ≥ 126mg/dL and < 240mg/dL at screening
  • Body Mass Index (BMI) 20.0 - 45.0 kg/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
  • Significant renal, hepatic or cardiovascular diseases
  • Severe gastrointestinal diseases

Treatment and study plan

ASP1941

Drug

oral

Placebo

Drug

oral

Primary outcomes

  1. Change in plasma glucose levels

    Time frame: On day 14

Secondary outcomes

  1. Urinary glucose excursion

    Time frame: On day 14

  2. Pharmacokinetic parameter of ASP1941

    Time frame: On day 14

  3. Safety by adverse events, routine safety laboratories and vital signs.

    Time frame: During treatment

  4. Change in serum insulin levels

    Time frame: On day 14

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo Controlled, Monotherapy Study to Assess the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 2, 2009
Registry last updated
Nov 12, 2024

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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