A Study to Evaluate Long-term Safety and Efficacy of ASP1941 in Diabetes Patients

Phase III Study of ASP1941 -A Phase III, Open-Label, Uncontrolled, Monotherapy Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

This study is to evaluate safety and efficacy of ASP1941 after 24 week administration to diabetic patients.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: ipragliflozin

Detailed Description

Subjects will undergo the 6-week screening period before entering the 24-week treatment period and will receive ASP1941 before breakfast during the treatment period. All subjects will be followed for 4 weeks after study treatment is discontinued.

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Chubu, Japan
  • Hokkaido, Japan
  • Kansai, Japan
  • Kantou, Japan
  • Kyushu, Japan
  • Shikoku, Japan
  • Touhoku, Japan

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Type 2 diabetes mellitus patients
• Subject is only on a diet and exercise program or has received a single antihyperglycemic agent or two antihyperglycemic agents (excluding insulin) with low dose (≤50% of the maximum dose of each recommended dosage)
• Subject has a HbA1c value (JDS value) between 6.5% and 9.5% and the difference of HbA1c values (JDS value) within ± 1.0%
• BMI 20.0 - 45.0 kg/m2

Exclusion Criteria:

• Type 1 Diabetes Mellitus
• Subject has received insulin within 12 weeks (84 days) before the study
• Subject has proliferative diabetic retinopathy
• Subject has a history of clinically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant
• Subject with obvious dysuria caused by a neurogenic bladder or a benign prostatic hypertrophy
• Subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, and heart disease (NYHA Class III-IV) within 12 weeks (84 days). Subject has heart disease, cerebral vascular disease which, in the opinion of the principal investigator or the sub-investigator, may interfere with treatment or evaluation of safety of this study.
• Female subject who is currently pregnant or lactating, or who is possibly pregnant
• Male and pre-menopausal Female subject who cannot use an appropriate contraception during the study
• Subject has a history of treatment with ASP1941
• Subject has participated in another clinical study, post marketing study, or medical equipment study within 12 weeks (84 days) before providing written informed consent, or who is currently participating in any of those studies
• Subject has a serum creatinine value higher than upper limit of normal range
• Subject has a urinary microalbumin/ urinary creatinine ratio > 300 mg/g in urinalysis
• Subject has uncontrolled severe hypertension (subject whose systolic blood pressure is > 170 mmHg or diastolic blood pressure of > 95 mmHg measured in a sitting position after 5 minutes of rest
• Subject who is judged inappropriate for enrollment into the study by the principal investigator or the sub-investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASP1941 group; oral	Drug: ipragliflozin; oral; Other Names: ASP1941

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c	Before and at 4-, 8-, 12-, 16-, 20- and 24-week

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in fasting plasma glucose	Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Change in fasting serum insulin	Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Change in waist circumference	Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Change in body weight	Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Change in urine glucose	Before and at 4-, 8-, 12-, 16-, 20- and 24-week
Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECGs	24 weeks

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Investigators: Study Director: Medical Director, 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): May 25, 2012
• Primary Completion (Actual): April 13, 2013
• Study Completion (Actual): April 13, 2013

Study Registration Dates

• First Submitted: August 22, 2012
• First Submitted That Met QC Criteria: August 24, 2012
• First Posted (Estimated): August 27, 2012

Study Record Updates

• Last Update Posted (Actual): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: blood glucose; diabetes mellitus; ipragliflozin; hypoglycemic agents; glucose excretion; serum Insulin
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Ipragliflozin
• Other Study ID Numbers: 1941-CL-0122

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. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.