A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Sulfonylurea in Type 2 Diabetic Patients

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01242215

Collaborator

(none)

243

Enrollment

Locations

Arms

19.3

Actual Duration (Months)

34.7

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and sulfonylurea in patients with diabetes mellitus.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Device: ipragliflozin Drug: Placebo Drug: Sulfonylurea	Phase 3

Detailed Description

This study is to evaluate the efficacy and safety of ASP1941 in combination with sulfonylurea in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with sulfonylurea alone. The effects of ASP1941 are compared with those of placebo. Double blind period continues for 24 weeks followed by open period in each patient.

Study Design

Study Type:

Interventional

Actual Enrollment :

243 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase III Study to Assess the Efficacy, Safety and Tolerability of ASP1941 in Combination With Sulfonylurea in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Alone

Actual Study Start Date :

Sep 17, 2010

Actual Primary Completion Date :

Apr 25, 2012

Actual Study Completion Date :

Apr 25, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASP group ASP1941 and sulfonylurea	Device: ipragliflozin oral Other Names: ASP1941 Drug: Sulfonylurea oral Other Names: Glibenclamide Gliclazide Glimepiride
Placebo Comparator: Placebo group placebo and sulfonylurea	Drug: Placebo oral Drug: Sulfonylurea oral Other Names: Glibenclamide Gliclazide Glimepiride

Arm

Intervention/Treatment

Experimental: ASP group

ASP1941 and sulfonylurea

Device: ipragliflozin

oral

Other Names:

ASP1941

Drug: Sulfonylurea

oral

Other Names:

Glibenclamide

Gliclazide

Glimepiride

Placebo Comparator: Placebo group

placebo and sulfonylurea

Drug: Placebo

oral

Drug: Sulfonylurea

oral

Other Names:

Glibenclamide

Gliclazide

Glimepiride

Outcome Measures

Primary Outcome Measures

Change from baseline in HbA1c [Baseline and for 24 weeks]

Secondary Outcome Measures

Change from baseline in fasting plasma glucose [Baseline and for 24 weeks]
Change from baseline in fasting serum insulin [Baseline and for 24 weeks]
Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs) [for 52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Type 2 diabetic patients receiving with sulfonylurea mono-therapy for at least 4 weeks
HbA1c value between 7.0 and 9.5%
Body Mass Index (BMI) 20.0 - 45.0 kg/m2