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

Type II Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01514838
• Other study ID #: 1941-CL-2003
• Status: Terminated
• Phase: Phase 3
• Start date: April 23, 2012
• Est. completion date: October 19, 2012

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: October 19, 2012
• Est. primary completion date: October 19, 2012
• 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 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• ASP1941
oral
• acarbose
oral
• Placebo
oral, used only during placebo run-in period

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 body 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 website