A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01505426

Collaborator

(none)

171

Enrollment

Locations

Arms

13.6

Actual Duration (Months)

14.3

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian subjects with type 2 diabetes mellitus.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

171 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, Placebo-Controlled Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

Actual Study Start Date :

Nov 28, 2011

Actual Primary Completion Date :

Jan 14, 2013

Actual Study Completion Date :

Jan 14, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASP1941 group ASP1941 + metformin	Drug: ASP1941 oral Other Names: ipragliflozin Drug: metformin oral, concomitant use
Placebo Comparator: placebo group placebo + metformin	Drug: metformin oral, concomitant use Drug: Placebo oral

Arm

Intervention/Treatment

Experimental: ASP1941 group

ASP1941 + metformin

Drug: ASP1941

oral

Other Names:

ipragliflozin

Drug: metformin

oral, concomitant use

Placebo Comparator: placebo group

placebo + metformin

Drug: metformin

oral, concomitant use

Drug: Placebo

oral

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 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 8 weeks before the study
On a stable dose of at least 1500 mg/day metformin monotherapy or at least 1000 mg/day metformin monotherapy for the subject who can not titrate up to 1500 mg/day due to safety concern of metformin
BMI of 20.0 to 45.0 kg/m2
A HbA1c value between 7.0 and 10.0% at screening AND does not meet any of discontinuation criteria on fasting plasma glucose

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
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	Jeonju	Korea, Republic of
7	Seoul	Korea, Republic of
8	Wonju	Korea, Republic of
9	Kaohsiung	Taiwan
10	Taichung	Taiwan
11	Tainan	Taiwan
12	Taipei	Taiwan