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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
History of Changes
  Purpose

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


Condition Intervention Phase
Type II Diabetes Mellitus
 Drug: ASP1941
Drug: metformin
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 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change in HbA1c from baseline to end of treatment [ Time Frame: Baseline and up to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 171
Study Start Date: November 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP1941 group
ASP1941 + metformin
 Drug: ASP1941
oral
Other Name: ipragliflozin
Drug: metformin
oral, concomitant use
Placebo Comparator: placebo group
placebo + metformin
 Drug: metformin
oral, concomitant use
Drug: Placebo
oral

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505426

Locations
Korea, Republic of
Busan, Korea, Republic of
Daegu, Korea, Republic of
Daejeon, Korea, Republic of
Gwangju, Korea, Republic of
Incheon, Korea, Republic of
Jeonju, Korea, Republic of
Seoul, Korea, Republic of
Wonju, Korea, Republic of
Taiwan
Kaohsiung, Taiwan
Taichung, Taiwan
Tainan, Taiwan
Taipei, Taiwan
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: NCT01505426     History of Changes
Other Study ID Numbers: 1941-CL-2004
Study First Received: January 4, 2012
Last Updated: January 16, 2013
Health Authority: China: Food and Drug Administration
Korea: Food and Drug Administration
Taiwan: Department of Health

Keywords provided by Astellas Pharma Inc:
ASP1941
ipragliflozin
metformin
plasma glucose
urine glucose

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013