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

Type II Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01505426
• Other study ID #: 1941-CL-2004
• Status: Completed
• Phase: Phase 3
• Start date: November 28, 2011
• Est. completion date: January 14, 2013

Study information

• Verified date: October 2018
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: January 14, 2013
• Est. primary completion date: January 14, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• ASP1941
oral
• metformin
oral, concomitant use
• Placebo
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from baseline to end of treatment		Baseline and up to 24 weeks
Secondary	Change in fasting plasma glucose level		Baseline and up to 24 weeks
Secondary	Change in fasting serum insulin level		Baseline and up to 24 weeks
Secondary	Change in body weight		Baseline and up to 24 weeks
Secondary	Change in waist circumference		Baseline and up to 24 weeks
Secondary	Safety assessed by the incidence of adverse events, vital signs safety labo-tests and 12-lead ECG		For 24 weeks

External Links

•   Link to results on Astellas Clinical Study Results Web site