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 24, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Type II Diabetes Mellitus
Drug: ASP1941
Drug: acarbose
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, Active Controlled, Monotherapy Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


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 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 ]

Enrollment: 46
Study Start Date: January 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1941 group Drug: ASP1941
oral
Other Name: ipragliflozin
Drug: Placebo
oral, used only during placebo run-in period
Active Comparator: acarbose group Drug: acarbose
oral
Drug: Placebo
oral, used only during placebo run-in period

Detailed Description:

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.

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514838

Locations
Korea, Republic of
Busan, Korea, Republic of
Daegu, Korea, Republic of
Daejeon, Korea, Republic of
Gwangju, Korea, Republic of
Incheon, Korea, Republic of
Seongnam, Korea, Republic of
Seoul, Korea, Republic of
Wonju, Korea, Republic of
Taiwan
Changha, Taiwan
Chiayi, Taiwan
Kaohsiung, Taiwan
Taichung, Taiwan
Tainan, Taiwan
Taipei, Taiwan
Taoyuan, 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: NCT01514838     History of Changes
Other Study ID Numbers: 1941-CL-2003
Study First Received: January 18, 2012
Last Updated: October 24, 2012
Health Authority: China: Food and Drug Administration
Korea: Food and Drug Administration
Taiwan: Department of Health

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Acarbose
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014