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

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.
ClinicalTrials.gov Identifier: NCT01505426
Recruitment Status : Completed
First Posted : January 6, 2012
Last Update Posted : January 20, 2016
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Type II Diabetes Mellitus Drug: ASP1941 Drug: metformin Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2011
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ASP1941 group
ASP1941 + metformin
Drug: ASP1941
Other Name: ipragliflozin
Drug: metformin
oral, concomitant use
Placebo Comparator: placebo group
placebo + metformin
Drug: metformin
oral, concomitant use
Drug: Placebo

Outcome Measures

Primary Outcome Measures :
  1. Change in HbA1c from baseline to end of treatment [ Time Frame: Baseline and up to 24 weeks ]

Secondary Outcome Measures :
  1. Change in fasting plasma glucose level [ Time Frame: Baseline and up to 24 weeks ]
  2. Change in fasting serum insulin level [ Time Frame: Baseline and up to 24 weeks ]
  3. Change in body weight [ Time Frame: Baseline and up to 24 weeks ]
  4. Change in waist circumference [ Time Frame: Baseline and up to 24 weeks ]
  5. Safety assessed by the incidence of adverse events, vital signs safety labo-tests and 12-lead ECG [ Time Frame: For 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505426

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
Kaohsiung, Taiwan
Taichung, Taiwan
Tainan, Taiwan
Taipei, Taiwan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc
More Information

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01505426     History of Changes
Other Study ID Numbers: 1941-CL-2004
First Posted: January 6, 2012    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:
plasma glucose
urine glucose

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