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 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
143
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
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
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
19 år til 74 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: ASP1941 group
once daily over a 24 week treatment
|
muntlig
Andre navn:
|
|
Placebo komparator: Placebo group
once daily over a 24 week treatment
|
muntlig
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change from baseline in HbA1c at the end of treatment
Tidsramme: at 24 weeks
|
at 24 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
22. juni 2015
Primær fullføring (Faktiske)
5. januar 2017
Studiet fullført (Faktiske)
5. januar 2017
Datoer for studieregistrering
Først innsendt
14. mai 2015
Først innsendt som oppfylte QC-kriteriene
20. mai 2015
Først lagt ut (Anslag)
22. mai 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. november 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. november 2018
Sist bekreftet
1. november 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1941-CL-2009
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Tilgangskriterier for IPD-deling
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 Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .