Phase 2 Study of DS-8500a in Patients With Type 2 Diabetes
8. februar 2019 opdateret af: Daiichi Sankyo Co., Ltd.
A Phase 2, Placebo-controlled, Double-blind Study of DS-8500a in Patients With Type 2 Diabetes
The objective of this study is to evaluate the efficacy and safety of DS-8500a compared with placebo in Japanese patients with Type 2 Diabetes Mellitus.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The objective of this study is to evaluate the efficacy and safety of DS-8500a 10 mg and 75 mg administered orally, once daily, for 28 days, compared with placebo, in Japanese patients with Type 2 Diabetes Mellitus in a double-blind, placebo-controlled parallel-group design.
The primary endpoint is the change in 24-hour weighted mean glucose at day 28 from baseline.
The safety, pharmacokinetics, and pharmacodynamics of DS-8500a will be evaluated as well.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
100
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Osaka
-
Kasuga, Osaka, Japan, 565-0853
- Heishinkai Medical Group Incorporated OCROM Clinic
-
-
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
20 år til 69 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients aged ≥ 20 years at the time of informed consent
- Japanese patients with type 2 diabetes
- Patients who have HbA1c ≥ 7.0% and < 10.0% if untreated with antidiabetic agent.
- Patients who have HbA1c ≥ 6.5% and < 9.5% if treated with antidiabetic agent.
Exclusion Criteria:
- Patients aged ≥ 70 years at the time of informed consent
- Patients with a history of type 1 diabetes or diabetic ketoacidosis
- Patients receiving or requiring treatment with insulin
- Patients with a body mass index (BMI) of < 18.5 kg/m2 or ≥ 35.0 kg/m2
- Patients with an estimated glomerular filtration rate (eGFR), < 45 mL/min per 1.73 m2
- Patients with fasting plasma glucose ≥ 240 mg/dL
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: DS-8500a 10mg once daily
10mg DS-8500a tablet given orally once daily
|
|
|
Eksperimentel: DS8500a 75 mg once daily
75mg DS-8500a tablet given orally once daily
|
|
|
Placebo komparator: placebo to match DS-8500a tablet
placebo matching DS-8500a tablet
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
change in 24-hour weighted mean blood glucose
Tidsramme: Day -1 (baseline) to Day 28
|
Day -1 (baseline) to Day 28
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
change in 24 hour weighted mean blood glucose
Tidsramme: Day -1 (baseline) to Day 14
|
Day -1 (baseline) to Day 14
|
|
|
change in blood fasting plasma glucose level
Tidsramme: Day -1 (baseline) to Days 7, 14, 21, 28
|
Day -1 (baseline) to Days 7, 14, 21, 28
|
|
|
change in blood plasma glucose level
Tidsramme: Day -1 (baseline) to Days 14 and 28
|
Change in the parameter at Day 14 or 28 from Day -1
|
Day -1 (baseline) to Days 14 and 28
|
|
change in blood insulin level
Tidsramme: Day -1 (baseline) to Days 14 and 28
|
Change in the parameter at Day 14 or 28 from Day -1
|
Day -1 (baseline) to Days 14 and 28
|
|
change in blood C-peptide level
Tidsramme: Day -1 (baseline) to Days 14 and 28
|
Change in the parameter at Day 14 or 28 from Day -1
|
Day -1 (baseline) to Days 14 and 28
|
|
change in blood active GLP-1 level
Tidsramme: Day -1 (baseline) to Days 14 and 28
|
Change in the parameter at Day 14 or 28 from Day -1
|
Day -1 (baseline) to Days 14 and 28
|
|
change in blood PYY level
Tidsramme: Day -1 (baseline) to Days 14 and 28
|
Change in the parameter at Day 14 or 28 from Day -1
|
Day -1 (baseline) to Days 14 and 28
|
|
change in blood HbA1c level
Tidsramme: Day -1 (baseline) to Days 14 and 28
|
Change in the parameter at Day 14 or 28 from Day -1
|
Day -1 (baseline) to Days 14 and 28
|
|
change in blood glycoalbumin level
Tidsramme: Day -1 (baseline) to Days 14 and 28
|
Change in the parameter at Day 14 or 28 from Day -1
|
Day -1 (baseline) to Days 14 and 28
|
|
Number of subjects experiencing adverse events as a measure of safety
Tidsramme: Day -1 (baseline) to Day 28
|
Number of subjects experiencing adverse events
|
Day -1 (baseline) to Day 28
|
|
pharmacokinetic profile of DS-8500a
Tidsramme: Day -1 (baseline) to Day 28
|
Pharmacokinetic profile of DS-8500a in Japanese subjects with type 2 diabetes mellitus.
i.e.
Tmax, Cmax, AUC, t1/2
|
Day -1 (baseline) to Day 28
|
|
change in postprandial plasma glucose level
Tidsramme: Day -1 (baseline) to Days 14 and 28
|
Change in postprandial plasma glucose level (2 hours after a meal) at Day 14 or 28 from Day -1
|
Day -1 (baseline) to Days 14 and 28
|
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.
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
1. juli 2014
Primær færdiggørelse (Faktiske)
1. november 2014
Studieafslutning (Faktiske)
1. januar 2015
Datoer for studieregistrering
Først indsendt
18. august 2014
Først indsendt, der opfyldte QC-kriterier
19. august 2014
Først opslået (Skøn)
21. august 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. februar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. februar 2019
Sidst verificeret
1. april 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DS8500-A-J201
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/.
In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants.
Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD-delingstidsramme
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD-delingsadgangskriterier
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research.
This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
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