- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03006159
A Phase 1, Randomized, Placebo-controlled, Multiple Dose Escalation Study to Investigate Safety, Pharmacokinetics, and Pharmacodynamics of SHR0534 in Chinese Type 2 Diabetic Patients
28. december 2016 opdateret af: Jiangsu HengRui Medicine Co., Ltd.
This is a randomized, placebo-controlled, multiple dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534.
The study will be conducted with dose of 5 mg, 10mg and 25 mg.
Chinese Type 2 Diabetic patients will be randomized in each cohort to receive the study drug or placebo.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
36
Fase
- Fase 1
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 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Type 2 diabetes diagnosed for more than 3 months;
- HbA1c between ≥7.0 and ≤10.5% for naive patients, or ≥6.5 and ≤9.5% for patients treated with single oral drug, with FPG ≤13.9 mmol/L at randomization;
- Body Mass Index (BMI) between 18 and 40 kg/m^2 (inclusive) with a total body weight of at least 50 kg;
- Agree to stop any other drugs for diabetes during washout and study period;
- Serum C peptide concentration ≥0.8ng/mL at randomization.
Exclusion Criteria:
- Participated any drug clinical trials within 3 months or ≥3 times during the last year, or had blood donation/loss≥400mL or as Blood recipient within 3 months before randomization;
- History use of Insulin within 6 months;
- Drug or alcohol abuse within 6 months;
- Use any other hypoglycemic drugs or weight reducing drugs within 3 months, or use any grug or dietary supplements within 1 weeks prior to screening ;
- Underwent surgical procedures within 1 month prior to screening, or planned major surgical procedures during the study period;
- Subject who cannot refrain from smoking, eating and/or drinking containing xanthine/caffeine, or strenuous exercise, or others that affect drug absorption, distribution, metabolism and excretion within 2 days before the study drug administration;
- With active hepatitis;
- Uncontrolled endocrine system diseases (such as hyperthyroidism, hypothyroidism, Cushing syndrome, multiple endocrine neoplasia);
- Uncontrolled hypertension with systolic blood pressure (SBP) > 160mmHg and / or diastolic pressure (DBP) > 100 mmHg after drug treatment;
- History of recurrent severe hypoglycemia;
- With severe chronic gastrointestinal disease (e.g., an active ulcer within 6 months) or treatment that may affect drug absorption (e.g., gastrointestinal surgery);
- With any cancer (other than skin basal cell carcinoma) that has been treated or untreated within the last 5 years;
- History of decompensated heart failure (NYHA grade III and IV), unstable angina, stroke or transient ischemic attack, persistent myocardial infarction, and the clinical significance of arrhythmia (such as frequent contractions), or had coronary artery bypass grafting or percutaneous coronary intervention within 6 months;
- History of acute metabolic complications, or proliferative retinopathy or maculopathy which required acute treatment within 6 months;
- Severe trauma or severe infection that may affect glycemic control within 1 months before screening;
- AST, ALT or TBIL>1.5×UNL, or Cre>1.5 mg/dL(male)/1.4 mg/dL(female), or ACR>300mg/g at screening;
- Positive of hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody;
- With clinical significance abnormal of ECGs, such as II or III degree atrioventricular block (except right bundle branch block), long QT syndrome or QTc>500 MS;
- Subject was not suitable for the study as determined by the Investigator.
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: Cohort 1
Twelve Type 2 Diabetic Patients were randomized in 5:1 ratio to receive multiple (30 days) oral dose of 5 mg SHR0534 or matching placebo.
|
|
Eksperimentel: Cohort 2
Twelve Type 2 Diabetic Patients were randomized in 5:1 ratio to receive multiple (30 days) oral dose of 10 mg SHR0534 or matching placebo.
|
|
Eksperimentel: Cohort 3
Twelve Type 2 Diabetic Patients were randomized in 5:1 ratio to receive multiple (30 days) oral dose of 25 mg SHR0534 or matching placebo.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of treatment emergent adverse events
Tidsramme: From baseline up to 8 days after last treatment (Day 38)
|
From baseline up to 8 days after last treatment (Day 38)
|
Area under the plasma concentration curve after the first and last multiple oral dose (AUC)
Tidsramme: From time 0 to 24 hours for the first dose, and from time 0 to 192 hours after the last dose
|
From time 0 to 24 hours for the first dose, and from time 0 to 192 hours after the last dose
|
Peak plasma concentration (Cmax) after the first and last multiple oral dose
Tidsramme: From time 0 to 24 hours for the first dose, and from time 0 to 192 hours after the last dose
|
From time 0 to 24 hours for the first dose, and from time 0 to 192 hours after the last dose
|
Terminal elimination halflife (t½) for SHR0534 after the last multiple oral dose
Tidsramme: From time 0 to 192 hours after the last dose
|
From time 0 to 192 hours after the last dose
|
Changes in the concentrations of blood glucose and insulin after multiple oral dose
Tidsramme: From baseline up to 24 hours after last treatment (Day 31)]
|
From baseline up to 24 hours after last treatment (Day 31)]
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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. marts 2015
Primær færdiggørelse (Faktiske)
1. december 2015
Studieafslutning (Faktiske)
1. marts 2016
Datoer for studieregistrering
Først indsendt
28. december 2016
Først indsendt, der opfyldte QC-kriterier
28. december 2016
Først opslået (Skøn)
30. december 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. december 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. december 2016
Sidst verificeret
1. december 2016
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- SHR0534-Ib
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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 .
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