A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01505426
First received: January 4, 2012
Last updated: January 16, 2013
Last verified: January 2013

January 4, 2012
January 16, 2013
November 2011
January 2013   (final data collection date for primary outcome measure)
Change in HbA1c from baseline to end of treatment [ Time Frame: Baseline and up to 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01505426 on ClinicalTrials.gov Archive Site
  • Change in fasting plasma glucose level [ Time Frame: Baseline and up to 24 weeks ] [ Designated as safety issue: No ]
  • Change in fasting serum insulin level [ Time Frame: Baseline and up to 24 weeks ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: Baseline and up to 24 weeks ] [ Designated as safety issue: No ]
  • Change in waist circumference [ Time Frame: Baseline and up to 24 weeks ] [ Designated as safety issue: No ]
  • Safety assessed by the incidence of adverse events, vital signs safety labo-tests and 12-lead ECG [ Time Frame: For 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients
A Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian subjects with type 2 diabetes mellitus.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type II Diabetes Mellitus
  • Drug: ASP1941
    oral
    Other Name: ipragliflozin
  • Drug: metformin
    oral, concomitant use
  • Drug: Placebo
    oral
  • Experimental: ASP1941 group
    ASP1941 + metformin
    Interventions:
    • Drug: ASP1941
    • Drug: metformin
  • Placebo Comparator: placebo group
    placebo + metformin
    Interventions:
    • Drug: metformin
    • 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
171
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosed as type 2 diabetes mellitus patient at least 12 weeks before the study
  • Stable diet and exercise program for at least 8 weeks before the study
  • On a stable dose of at least 1500 mg/day metformin monotherapy or at least 1000 mg/day metformin monotherapy for the subject who can not titrate up to 1500 mg/day due to safety concern of metformin
  • BMI of 20.0 to 45.0 kg/m2
  • A HbA1c value between 7.0 and 10.0% at screening AND does not meet any of discontinuation criteria on fasting plasma glucose

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Proliferative diabetic retinopathy
  • Receiving insulin within 12 weeks prior to the study
  • History of clinically significant renal disease(s)
  • Significant dysuria caused by a neurogenic bladder or a benign prostate hypertrophy etc.
  • Urinary tract infection or genital infection
  • Continuous use of systemic corticosteroids, immunosuppressants, or loop diuretics
  • History of cerebrovascular attack, unstable angina, myocardial infarction, angioplasty, serious cardiac diseases within 12 weeks prior to the study
  • Severe infection, serious trauma, or perioperative subject
  • Known or suspected hypersensitivity to ASP1941
  • History of treatment with ASP1941
  • Participated in another clinical study, postmarketing study or medical device study within 12 weeks before the study
  • Serum creatinine value exceeding the upper limit of normal range
  • Urinary microalbumin/urinary creatinine ratio >300 mg/g
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan,   Korea, Republic of
 
NCT01505426
1941-CL-2004
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
January 2013

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