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A Study to Assess the Efficacy and Safety of ASP1941 in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study to Assess the Efficacy and Safety of ASP1941 in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin

A Phase 3, Multicenter, Double-Blind, Randomized, Parallel-group, Placebo-Controlled Study to Assess the Efficacy and Safety of ASP1941 in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin

NCT02452632•Astellas Pharma Korea, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the efficacy and safety of ASP1941 50mg once daily in combination with metformin and sitagliptin against placebo in combination with metformin and sitagliptin over a 24 week treatment period in subjects with type 2 diabetes mellitus with inadequate glycemic control on metformin and sitagliptin.

Eligibility

Age

19 - 74 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject has been diagnosed with type 2 diabetes mellitus.
•Subject has an HbA1c value between 7.0% and 10.5 % at visit 1.
•Subject shows FPG (Fasting Plasma Glucose) value is less than 270mg/dL.
•Subject shows a BMI of 20.0 to 45.0 kg/m2.
•Subject is on stable diet and exercise program at least 8 weeks prior to study participation.
•Postmenopausal female or surgically sterile female or agree not to become pregnant.

Exclusion Criteria

•Subject has type 1 diabetes mellitus.
•Subject has proliferative diabetic retinopathy.
•Subject has a history of clinically significant renal disease(s) such as renovascular occlusive disease, nephrectomy, or renal transplant.
•Subject has significant dysuria caused by a neurogenic bladder or a benign prostatic hypertrophy etc.
•Subject has a symptomatic urinary tract infection or genital infection.
•Subject has chronic disease(s) that require the continuous use of systemic corticosteroids or immunosuppressants.
•Subject has cardiovascular disease or cerebrovascular disease that may affect the administration of ASP1941 or its safety assessment in the opinion of the investigator or sub-investigator.
•Subject has uncontrollable psychiatric disorder(s) with medication.
•Male subject is not willing to use appropriate contraception during the study.
•Subject has severe infection, serious trauma, or perioperative subject.
+16 more criteria

Locations (22)

Site KR00019

Dong Gu Gwangju, Dong Gu Gwangju, South Korea

Site KR00008

Gangwon-do, Gangwon-do, South Korea

Site KR00020

Jeollabuk-do, Jeollabuk-do, South Korea

Site KR00021

Kyungsangnam-do, Kyungsangnam-do, South Korea

Site KR00002

Busan, South Korea

Site KR00003

Busan, South Korea

Site KR00007

Daegu, South Korea

Site KR00011

Daegu, South Korea

Site KR00018

Gyeonggi-do, South Korea

Site KR00022

Gyeonggi-do, South Korea

Key Dates

Start Date

June 22, 2015

Primary Completion Date

January 5, 2017

Completion Date

January 5, 2017

Last Updated

November 12, 2024

Enrollment

143

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Interventions

ASP1941

DRUG

Placebo

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGNA

Achieving Routine Intervention and Screening for Emotional Health

NCT06887049

Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Assess the Efficacy and Safety of ASP1941 in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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