A Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus

This study has been terminated.
(Discontinued due to company's strategic reason)
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01514838
First received: January 18, 2012
Last updated: October 28, 2014
Last verified: October 2014

January 18, 2012
October 28, 2014
January 2012
October 2012   (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 NCT01514838 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 body 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 Asian Subjects With Type 2 Diabetes Mellitus
A Phase III, Double-Blind, Randomized, Active Controlled, Monotherapy Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to assess the efficacy of ASP1941 based on the changes in HbA1C as well as its safety in Asian subjects with type 2 diabetes mellitus.

This is a multi-center, active-controlled, double-blind, double-dummy, parallel-group comparative study. After a screening period followed by a placebo run-in period under the single-blind condition, subjects will be randomized to either the ASP1941 or the acarbose group. Subjects will take the study drug under the double-blind condition in the treatment period. After completion of the study drug administration, a follow-up period will be 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: acarbose
    oral
  • Drug: Placebo
    oral, used only during placebo run-in period
  • Experimental: 1941 group
    Interventions:
    • Drug: ASP1941
    • Drug: Placebo
  • Active Comparator: acarbose group
    Interventions:
    • Drug: acarbose
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
46
October 2012
October 2012   (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 6 weeks before the study
  • for the hypoglycemic agent non-naïve subject, subject has been receiving a single hypoglycemic agent or low-dose of a dual combination therapy
  • BMI of 20.0 to 45.0 kg/m2
  • for the hypoglycemic agent non-naïve subject, subject has a HbA1c value between 6.8 and 10.0% at screening AND has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period
  • for the hypoglycemic agent naïve subject, subject has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period

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, acarbose or other alpha-GI
  • 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
Korea, Republic of,   Taiwan
 
NCT01514838
1941-CL-2003
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
October 2014

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