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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01242215
• Other study ID #: 1941-CL-0109
• Status: Completed
• Phase: Phase 3
• Start date: September 17, 2010
• Est. completion date: April 25, 2012

Study information

• Verified date: April 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: April 25, 2012
• Est. primary completion date: April 25, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Exclusion Criteria:

• Type 1 diabetes mellitus patients

• Serum creatinine > upper limit of normal

• Proteinuria (albumin/creatinine ratio > 300mg/g)

• Dysuria and/or urinary tract infection, genital infection

• Significant renal, hepatic or cardiovascular diseases

• Severe gastrointestinal diseases

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Device:
• ipragliflozin
oral

Drug:
• Placebo
oral
• Sulfonylurea
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c		Baseline and for 24 weeks
Secondary	Change from baseline in fasting plasma glucose		Baseline and for 24 weeks
Secondary	Change from baseline in fasting serum insulin		Baseline and for 24 weeks
Secondary	Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)		for 52 weeks

External Links

•   Link to results on Astellas Clinical Study Results website