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

Phase 3

Terminated

• Conditions: Type II Diabetes Mellitus
• Interventions: Drug: ASP1941; Drug: acarbose; Drug: Placebo

• Registration Number: NCT01514838
• Lead Sponsor: Astellas Pharma Inc

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.

Study Timeline

• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-23
• Study Start: 2012-04-23
• Primary Completion: 2012-10-19
• Study Completion: 2012-10-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1941 group	ASP1941	Once daily over a 24-week treatment period
1941 group	Placebo	Once daily over a 24-week treatment period
acarbose group	acarbose	Once daily over a 24-week treatment period
acarbose group	Placebo	Once daily over a 24-week treatment period

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline to end of treatment	Baseline and up to 24 weeks

Secondary Outcome Measures

Name	Time	Method
Change in fasting serum insulin level	Baseline and up to 24 weeks
Change in body waist circumference	Baseline and up to 24 weeks
Change in fasting plasma glucose level	Baseline and up to 24 weeks
Change in body weight	Baseline and up to 24 weeks
Safety assessed by the incidence of adverse events, vital signs safety labo-tests and 12-lead ECG	For 24 weeks