- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01590797
A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Insulin With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-254)
20. juli 2018 opdateret af: Merck Sharp & Dohme LLC
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial in China to Study the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Insulin Therapy, Alone or in Combination With Metformin
A study to compare safety and efficacy of sitagliptin and placebo therapy when added to stable insulin alone or in combination with metformin in participants with type 2 diabetes mellitus (T2DM).
The primary hypothesis of this study is that after 24 weeks, the addition of sitagliptin compared with placebo provides greater reduction in hemoglobin A1C (HbA1C) in T2DM participants on insulin alone or in combination with metformin.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
467
Fase
- Fase 3
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
18 år til 79 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- has T2DM
- is currently on a stable regimen of pre-mixed, intermediate-acting, or long-acting insulin at a dose of at least 12 U/day, either alone or in combination with metformin >=1500 mg/day for ≥ 10 weeks
- has a Visit 1/Screening HbA1C between 7.5% and 11.0%
- is a male, or a female who is highly unlikely to conceive during the study and for 14 days after the last dose of study medication
Exclusion Criteria:
- has been treated with any antihyperglycemic therapies other than a protocol-required insulin (alone or with metformin) within the prior 12 weeks or has ever
been treated with a dipeptidyl peptidase-4 inhibitor or a glucagon-like peptide-1 mimetic or analogue
- is currently on treatment with daily use (one or more injections per day) of
pre-prandial short-acting or rapid-acting insulin
- has a history of 2 or more episodes of hypoglycemia resulting in seizure,
coma, or loss of consciousness, or has had recurrent episodes of hypoglycemia over the past 8 weeks
- has a history of intolerance or hypersensitivity, or has any contraindication to sitagliptin, insulin, or metformin
- is on a weight loss program and not in the maintenance phase, or has started a weight loss medication or has undergone bariatric surgery within 12 months
- has undergone a surgical procedure within 4 weeks or has planned major surgery during the study
- has a medical history of active liver disease
- has had new or worsening signs or symptoms of coronary heart disease within the past 3 months, or has acute coronary syndrome, coronary artery intervention, or stroke or transient ischemic neurological disorder
- has a diagnosis of congestive heart failure with New York Heart Association Class III - IV cardiac status
- has a systolic blood pressure ≥ 160 mmHg or a diastolic blood pressure ≥ 90 mmHg
- has human immunodeficiency virus (HIV)
- has severe peripheral vascular disease
- is currently being treated for hyperthyroidism or is on thyroid hormone therapy and has not been on a stable dose for at least 6 weeks
- has a history of malignancy ≤ 5 years before the study, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
- has a clinically important hematological disorder (such as aplastic anemia,
myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
- is pregnant or breast feeding, or is expecting to conceive or donate eggs during the study, including 14 days after the last dose of study medication
- is a user of recreational or illicit drugs or has had a recent history of drug abuse
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: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Sitagliptin
Participants treated with sitagliptin 100 mg, once daily, for 24 weeks.
All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study.
All participants will receive placebo during the Placebo Run-in period.
|
Sitagliptin 100 mg once daily for 24 weeks
Andre navne:
Participants can be on on pre-mixed (mixture of rapid- and long-acting insulin) or intermediate- or long-acting insulin at a dose of at least 12 U/day.
At randomization, participants will be stratified according to their use of metformin (on or not on).
All participants receiving metformin will be required to be on a daily dose of metformin at least 1500 mg per day.
|
Placebo komparator: Placebo
Participants treated with placebo matching sitagliptin, once daily, for 24 weeks.
All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study.
All participants will receive placebo during the Placebo Run-in period.
|
Participants can be on on pre-mixed (mixture of rapid- and long-acting insulin) or intermediate- or long-acting insulin at a dose of at least 12 U/day.
At randomization, participants will be stratified according to their use of metformin (on or not on).
All participants receiving metformin will be required to be on a daily dose of metformin at least 1500 mg per day.
Matching placebo once daily for 24 weeks
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change From Baseline in Hemoglobin A1C (HbA1C) Levels at Week 24 in Participants Receiving Insulin Alone or in Combination With Metformin
Tidsramme: Baseline and Week 24
|
Baseline and Week 24
|
|
Number of Participants With One or More Adverse Events
Tidsramme: Up to Week 26
|
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
Up to Week 26
|
Number of Participants Discontinuing Study Medication Due to an AE
Tidsramme: Up to Week 24
|
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
Up to Week 24
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change From Baseline in HbA1C Levels at Week 24 in Participants Receiving Insulin in Combination With Metformin
Tidsramme: Baseline and Week 24
|
Baseline and Week 24
|
Change From Baseline in 2-Hour Post Meal Glucose Levels at Week 24 in Participants Receiving Insulin Alone or in Combination With Metformin
Tidsramme: Baseline and Week 24
|
Baseline and Week 24
|
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 (Faktiske)
10. juli 2012
Primær færdiggørelse (Faktiske)
11. juni 2014
Studieafslutning (Faktiske)
25. juni 2014
Datoer for studieregistrering
Først indsendt
1. maj 2012
Først indsendt, der opfyldte QC-kriterier
2. maj 2012
Først opslået (Skøn)
3. maj 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. august 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. juli 2018
Sidst verificeret
1. juli 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Sygdomme i det endokrine system
- Diabetes mellitus
- Diabetes mellitus, type 2
- Hypoglykæmiske midler
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Proteasehæmmere
- Inkretiner
- Dipeptidyl-Peptidase IV-hæmmere
- Metformin
- Sitagliptin fosfat
Andre undersøgelses-id-numre
- 0431-254
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Studiedata/dokumenter
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 .
Kliniske forsøg med Type 2 diabetes mellitus
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Merck Sharp & Dohme LLCAfsluttetType 2 diabetes mellitus (T2DM)
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AstraZenecaBristol-Myers SquibbAfsluttet
Kliniske forsøg med Sitagliptin
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Shahid Beheshti University of Medical SciencesIsfahan University of Medical SciencesAfsluttet
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Afsluttet
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University of Colorado, DenverMerck Sharp & Dohme LLCAfsluttetKardiovaskulær sygdom | Type 2 diabetesForenede Stater
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National Institute on Aging (NIA)Afsluttet
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Eurofarma Laboratorios S.A.AfsluttetDiabetes mellitus, type 2Brasilien
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University of VermontMerck Sharp & Dohme LLCUkendt
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University Hospital Inselspital, BerneFresenius KabiAfsluttetUnderernæring | Gastrointestinale tumorerSchweiz