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Completed

NCT Number: NCT00621868

A Study of ASP1941 in Participants With Type 2 Diabetes Mellitus

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP1941 in male and female patients with type 2 diabetes mellitus

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Key information

Conditions

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 2

Primary location

Chugoku, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Established diagnosis of type 2 diabetes mellitus
  • Fasting serum C-peptide level > 0.6 ng/mL
  • HbA1c between 7.0 and 10.0%
  • Body Mass Index between 20 and 45 kg/m2

Exclusion criteria

  • Serum creatinine > upper limit of normal
  • Proteinuria (albumin/creatinine ratio > 300 mg/g)
  • Dysuria and/or urinary tract infection
  • Significant renal, hepatic or cardiovascular diseases
  • Ketosis
  • Hypertension
  • Severe gastrointestinal diseases

Treatment and study plan

Ipragliflozin

Drug

Oral

Other names: ASP1941

Placebo

Drug

Oral

Primary outcomes

  1. HbA1c level

    Time frame: 12 weeks

Secondary outcomes

  1. Blood glucose level

    Time frame: 12 Weeks

  2. Safety

    Time frame: 12 Weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

ASP1941 Phase II Clinical Study - A Double-blind, Placebo-controlled, Parallel-group, Dose-response Study in Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 22, 2008
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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