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

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

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.

Study Overview

• Status: Terminated
• Conditions: Type II Diabetes Mellitus
• Intervention / Treatment: Drug: ASP1941; Drug: Placebo; Drug: acarbose

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
  • Daegu, Korea, Republic of
  • Daejeon, Korea, Republic of
  • Gwangju, Korea, Republic of
  • Incheon, Korea, Republic of
  • Seongnam, Korea, Republic of
  • Seoul, Korea, Republic of
  • Wonju, Korea, Republic of
• Taiwan
  • Changha, Taiwan
  • Chiayi, Taiwan
  • Kaohsiung, Taiwan
  • Taichung, Taiwan
  • Tainan, Taiwan
  • Taipei, Taiwan
  • Taoyuan, Taiwan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1941 group; Once daily over a 24-week treatment period	Drug: ASP1941; oral; Other Names: ipragliflozin; Drug: Placebo; oral, used only during placebo run-in period
Active Comparator: acarbose group; Once daily over a 24-week treatment period	Drug: Placebo; oral, used only during placebo run-in period; Drug: acarbose; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c from baseline to end of treatment	Baseline and up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Safety assessed by the incidence of adverse events, vital signs safety labo-tests and 12-lead ECG	For 24 weeks
Change in body waist circumference	Baseline and up to 24 weeks

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Publications and helpful links

Helpful Links

• Link to results on Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2012
• Primary Completion (Actual): October 19, 2012
• Study Completion (Actual): October 19, 2012

Study Registration Dates

• First Submitted: January 18, 2012
• First Submitted That Met QC Criteria: January 20, 2012
• First Posted (Estimate): January 23, 2012

Study Record Updates

• Last Update Posted (Actual): December 17, 2018
• Last Update Submitted That Met QC Criteria: December 13, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: ASP1941; plasma glucose; ipragliflozin; urine glucose
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Sodium-Glucose Transporter 2 Inhibitors; Glycoside Hydrolase Inhibitors; Acarbose; Ipragliflozin
• Other Study ID Numbers: 1941-CL-2003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."