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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01057628
First Posted: January 27, 2010
Last Update Posted: January 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc
January 25, 2010
January 27, 2010
January 20, 2016
January 2010
December 2010   (Final data collection date for primary outcome measure)
change from baseline in HbA1c [ Time Frame: 16 weeks ]
Same as current
Complete list of historical versions of study NCT01057628 on ClinicalTrials.gov Archive Site
  • change from baseline in fasting plasma glucose [ Time Frame: 16 weeks ]
  • change from baseline in fasting serum insulin [ Time Frame: 16 weeks ]
  • safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs) [ Time Frame: During treatment ]
Same as current
Not Provided
Not Provided
 
A Study to Assess the Efficacy and Safety of ASP1941 in Japanese Type 2 Diabetes Patients
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
This study is to compare the efficacy and safety of ASP1941 with placebo in Japanese patients with type 2 diabetes mellitus.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: ASP1941
    oral
  • Drug: placebo
    oral
  • Experimental: ASP1941 group
    Intervention: Drug: ASP1941
  • Placebo Comparator: placebo group
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
December 2010
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01057628
1941-CL-0105
No
Not Provided
Plan to Share IPD: Undecided
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP