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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Terminated

CT.gov ID

NCT01514838

Collaborator

(none)

Enrollment

Locations

Arms

5.9

Actual Duration (Months)

3.1

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type II Diabetes Mellitus	Drug: ASP1941 Drug: acarbose Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

46 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, Active Controlled, Monotherapy Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus

Actual Study Start Date :

Apr 23, 2012

Actual Primary Completion Date :

Oct 19, 2012

Actual Study Completion Date :

Oct 19, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1941 group Once daily over a 24-week treatment period	Drug: ASP1941 oral Other Names: ipragliflozin Drug: Placebo oral, used only during placebo run-in period
Active Comparator: acarbose group Once daily over a 24-week treatment period	Drug: acarbose oral Drug: Placebo oral, used only during placebo run-in period

Arm

Intervention/Treatment

Experimental: 1941 group

Once daily over a 24-week treatment period

Drug: ASP1941

oral

Other Names:

ipragliflozin

Drug: Placebo

oral, used only during placebo run-in period

Active Comparator: acarbose group

Once daily over a 24-week treatment period

Drug: acarbose

oral

Drug: Placebo

oral, used only during placebo run-in period

Outcome Measures

Primary Outcome Measures

Change in HbA1c from baseline to end of treatment [Baseline and up to 24 weeks]

Secondary Outcome Measures

Change in fasting plasma glucose level [Baseline and up to 24 weeks]
Change in fasting serum insulin level [Baseline and up to 24 weeks]
Change in body weight [Baseline and up to 24 weeks]
Change in body waist circumference [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	City	Country
1	Busan	Korea, Republic of
2	Daegu	Korea, Republic of
3	Daejeon	Korea, Republic of
4	Gwangju	Korea, Republic of
5	Incheon	Korea, Republic of
6	Seongnam	Korea, Republic of
7	Seoul	Korea, Republic of
8	Wonju	Korea, Republic of
9	Changha	Taiwan
10	Chiayi	Taiwan
11	Kaohsiung	Taiwan
12	Taichung	Taiwan
13	Tainan	Taiwan
14	Taipei	Taiwan
15	Taoyuan	Taiwan