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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01057628
First received: January 25, 2010
Last updated: October 10, 2011
Last verified: October 2011
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: ASP1941
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-Blind, Placebo-Controlled, Monotherapy Study to Assess the Efficacy, Safety and Tolerability of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • change from baseline in HbA1c [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change from baseline in fasting plasma glucose [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • change from baseline in fasting serum insulin [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs) [ Time Frame: During treatment ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP1941 group
none
Drug: ASP1941
oral
Placebo Comparator: placebo group
none
Drug: placebo
oral

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01057628

Locations
Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyushu, Japan
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01057628     History of Changes
Other Study ID Numbers: 1941-CL-0105
Study First Received: January 25, 2010
Last Updated: October 10, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
ASP1941
Diabetes mellitus
Blood glucose

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014