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
1 other identifier
interventional
143
1 country
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 type-2-diabetes-mellitus
Started Jun 2015
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2015
CompletedFirst Posted
Study publicly available on registry
May 22, 2015
CompletedStudy Start
First participant enrolled
June 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2017
CompletedNovember 12, 2024
November 1, 2024
1.5 years
May 14, 2015
November 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in HbA1c at the end of treatment
at 24 weeks
Secondary Outcomes (7)
Change from baseline in Fasting plasma glucose at the end of treatment
at 24 weeks
Change from baseline in Fasting serum insulin at the end of treatment
at 24 weeks
Change from baseline in Body weight at the end of treatment
at 24 weeks
Change from baseline in Waist circumference at the end of treatment
at 24 weeks
Safety assessed by development of adverse events, vital signs, laboratory tests, and 12-lead ECG
up to 24 weeks
- +2 more secondary outcomes
Study Arms (2)
ASP1941 group
EXPERIMENTALonce daily over a 24 week treatment
Placebo group
PLACEBO COMPARATORonce daily over a 24 week treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Subject has a malignant tumor or has a history of malignant tumor.
- Subject has severe gastrointestinal disease, or history of operation for serious gastrointestinal disease.
- Subject has diabetic ketoacidosis.
- Subject has lactic acidosis or has history of lactic acidosis.
- Subject has hepatitis or is a carrier of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or is positive for HIV-1 and/or HIV-2.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Site KR00014
Incheon, South Korea
Site KR00001
Seoul, South Korea
Site KR00004
Seoul, South Korea
Site KR00005
Seoul, South Korea
Site KR00006
Seoul, South Korea
Site KR00009
Seoul, South Korea
Site KR00010
Seoul, South Korea
Site KR00012
Seoul, South Korea
Site KR00013
Seoul, South Korea
Site KR00016
Seoul, South Korea
Site KR00017
Seoul, South Korea
Site KR00015
Suwon, South Korea
Related Publications (1)
Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12.
PMID: 31606880DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Korea, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2015
First Posted
May 22, 2015
Study Start
June 22, 2015
Primary Completion
January 5, 2017
Study Completion
January 5, 2017
Last Updated
November 12, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.