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
9. november 2018 opdateret af: Astellas Pharma Korea, Inc.
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
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
143
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Busan, Korea, Republikken
- Site KR00002
-
Busan, Korea, Republikken
- Site KR00003
-
Daegu, Korea, Republikken
- Site KR00007
-
Daegu, Korea, Republikken
- Site KR00011
-
Dong Gu Gwangju, Korea, Republikken
- Site KR00019
-
Gangwon-do, Korea, Republikken
- Site KR00008
-
Gyeonggi-do, Korea, Republikken
- Site KR00018
-
Gyeonggi-do, Korea, Republikken
- Site KR00022
-
Incheon, Korea, Republikken
- Site KR00014
-
Jeollabuk-do, Korea, Republikken
- Site KR00020
-
Kyungsangnam-do, Korea, Republikken
- Site KR00021
-
Seoul, Korea, Republikken
- Site KR00006
-
Seoul, Korea, Republikken
- Site KR00001
-
Seoul, Korea, Republikken
- Site KR00004
-
Seoul, Korea, Republikken
- Site KR00005
-
Seoul, Korea, Republikken
- Site KR00009
-
Seoul, Korea, Republikken
- Site KR00010
-
Seoul, Korea, Republikken
- Site KR00012
-
Seoul, Korea, Republikken
- Site KR00013
-
Seoul, Korea, Republikken
- Site KR00016
-
Seoul, Korea, Republikken
- Site KR00017
-
Suwon, Korea, Republikken
- Site KR00015
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
19 år til 74 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
- 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.
- Subject has a history of thyroid dysfunction and acute pancreatitis.
- Subject is on weight-loss program or weight-loss medication (e.g. orlistat, phentermine/topiramate, lorcaserin) within 12 weeks of study participation.
- Subject has a history of serious cardiac diseases (NYHA Class III to IV), congestive heart failure, arrhythmia in need of medical treatment.
- Subject has a history of cerebrovascular attack, unstable angina, myocardial infarction, angioplasty, within 52 weeks (364 days) of study participation.
- Subject has uncontrollable severe hypertension, i.e., systolic blood pressure of higher than 180 mmHg or diastolic blood pressure of higher than 110mmHg measured in a sitting position after a 5-minute rest.
Subject has following AST or ALT value:
- AST: Male > 100 U/L, Female > 80 U/L
- ALT: Male > 102.5 U/L, Female > 82.5 U/L
Subject has following serum creatinine value:
- Creatinine: Male > 1.3 mg/dL, Female > 1.2 mg/dL
- Subject has estimated GFR values, of < 60 mL/min/1.73m2.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: ASP1941 group
once daily over a 24 week treatment
|
mundtlig
Andre navne:
|
|
Placebo komparator: Placebo group
once daily over a 24 week treatment
|
mundtlig
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change from baseline in HbA1c at the end of treatment
Tidsramme: at 24 weeks
|
at 24 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in Fasting plasma glucose at the end of treatment
Tidsramme: at 24 weeks
|
at 24 weeks
|
|
|
Change from baseline in Fasting serum insulin at the end of treatment
Tidsramme: at 24 weeks
|
at 24 weeks
|
|
|
Change from baseline in Body weight at the end of treatment
Tidsramme: at 24 weeks
|
at 24 weeks
|
|
|
Change from baseline in Waist circumference at the end of treatment
Tidsramme: at 24 weeks
|
at 24 weeks
|
|
|
Safety assessed by development of adverse events, vital signs, laboratory tests, and 12-lead ECG
Tidsramme: up to 24 weeks
|
ECG: Electrocardiogram
|
up to 24 weeks
|
|
Number of subjects achieving the target HbA1c(<6.5% and <7.0%) at each visit
Tidsramme: at 4, 8, 12, 16 and 24 weeks
|
at 4, 8, 12, 16 and 24 weeks
|
|
|
Percentage of subjects achieving the target HbA1c(<6.5% and <7.0%) at each visit
Tidsramme: at 4, 8, 12, 16 and 24 weeks
|
at 4, 8, 12, 16 and 24 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
22. juni 2015
Primær færdiggørelse (Faktiske)
5. januar 2017
Studieafslutning (Faktiske)
5. januar 2017
Datoer for studieregistrering
Først indsendt
14. maj 2015
Først indsendt, der opfyldte QC-kriterier
20. maj 2015
Først opslået (Skøn)
22. maj 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. november 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. november 2018
Sidst verificeret
1. november 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1941-CL-2009
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development.
Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD-delingstidsramme
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.
IPD-delingsadgangskriterier
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.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .