Completed

Long-term Safety, Tolerability and Efficacy of ASP1941 in Japanese Patients with Type 2 Diabetes Mellitus

Study Aim

This study aims to evaluate the long-term safety, tolerability, and effectiveness of ASP1941 in managing blood sugar levels, measured by HbA1c changes, in Japanese patients with Type 2 Diabetes Mellitus.

What is being tested

ipragliflozin

Drug

Who is being recruted

Endocrine System Diseases+3

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

Over 20 Years

+18 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: May 2012

See protocol details

Summary

Principal SponsorAstellas Pharma Inc

Last updated: November 8, 2024

Sourced from a government-validated database.Claim as a partner

Study start date: May 25, 2012

Actual date on which the first participant was enrolled.

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.

NCT01672762

Principal SponsorAstellas Pharma Inc

Last updated: November 8, 2024

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

174 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes MellitusDiabetes Mellitus, Type 2

Criteria

4 inclusion criteria required to participate

BMI 20.0 - 45.0 kg/m2

Subject has a HbA1c value (JDS value) between 6.5% and 9.5% and the difference of HbA1c values (JDS value) within +/- 1.0%

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)

Type 2 diabetes mellitus patients

14 exclusion criteria prevent from participating

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 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

Subject has a history of clinically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

oral

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Chūbu, JapanOpen in Google Maps

Hokkaido, Japan

Kansai, Japan

Kantou, Japan

Completed7 Study Centers