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

NCT01672762 | Completed Phase 3

• 1 other identifier: 1941-CL-0122
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus

Keywords

glucose excretion; ipragliflozin; hypoglycemic agents; serum Insulin; diabetes mellitus; blood glucose

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Before and at 4-, 8-, 12-, 16-, 20- and 24-week

Secondary Outcomes (6)

• 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

Study Arms (1)

ASP1941 group

EXPERIMENTAL

oral

Drug: ipragliflozin

Interventions

ipragliflozin DRUG

oral

Also known as: ASP1941

ASP1941 group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (7)

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Unknown Facility

Shikoku, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

Related Links

• Link to results on Astellas Clinical Study Results website

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

ipragliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: August 27, 2012
• Study Start: May 25, 2012
• Primary Completion: April 13, 2013
• Study Completion: April 13, 2013
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (7)