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

Astellas

Status and phase: Terminated; Phase 3

Conditions: Type II Diabetes Mellitus

Treatments: Drug: acarbose; Drug: ASP1941; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01514838

1941-CL-2003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups

1941 group

Experimental group

Description:

Once daily over a 24-week treatment period

Treatment:

Drug: Placebo

Drug: ASP1941

acarbose group

Active Comparator group

Description:

Once daily over a 24-week treatment period

Treatment:

Drug: Placebo

Drug: acarbose