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

NCT ID: NCT01514838

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-23
• Study Completion Date: 2012-10-19

Brief Summary

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.

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.

Conditions

Type II Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1941 group

Once daily over a 24-week treatment period

Group Type: EXPERIMENTAL

ASP1941

Intervention Type: DRUG

oral

Placebo

Intervention Type: DRUG

oral, used only during placebo run-in period

acarbose group

Once daily over a 24-week treatment period

Group Type: ACTIVE_COMPARATOR

acarbose

Intervention Type: DRUG

oral

Placebo

Intervention Type: DRUG

oral, used only during placebo run-in period

Interventions

ASP1941

oral

Intervention Type: DRUG

acarbose

oral

Intervention Type: DRUG

Placebo

oral, used only during placebo run-in period

Intervention Type: DRUG

Other Intervention Names

ipragliflozin

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Use Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

Busan, , South Korea

Daegu, , South Korea

Daejeon, , South Korea

Gwangju, , South Korea

Incheon, , South Korea

Seongnam, , South Korea

Seoul, , South Korea

Wŏnju, , South Korea

Changha, , Taiwan

Chiayi City, , Taiwan

Kaohsiung City, , Taiwan

Taichung, , Taiwan

Tainan City, , Taiwan

Taipei, , Taiwan

Taoyuan District, , Taiwan

Countries

South Korea; Taiwan

Related Links

https://astellasclinicalstudyresults.com/study.aspx?ID=108

Link to results on Astellas Clinical Study Results website

Other Identifiers

1941-CL-2003

Identifier Type: -

Identifier Source: org_study_id