- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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. desember 2016 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
36
Fase
- Fase 1
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
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
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: 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.
|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
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)]
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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
1. mars 2015
Primær fullføring (Faktiske)
1. desember 2015
Studiet fullført (Faktiske)
1. mars 2016
Datoer for studieregistrering
Først innsendt
28. desember 2016
Først innsendt som oppfylte QC-kriteriene
28. desember 2016
Først lagt ut (Anslag)
30. desember 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
30. desember 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. desember 2016
Sist bekreftet
1. desember 2016
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- SHR0534-Ib
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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. .
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