A Phase 1, Randomized, Placebo-controlled, Multiple Dose Escalation Study to Investigate Safety, Pharmacokinetics, and Pharmacodynamics of SHR0534 in Chinese Type 2 Diabetic Patients
Overview
- Phase
- Phase 1
- Intervention
- SHR0534
- Conditions
- Type 2 Diabetic Patients
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrollment
- 36
- Primary Endpoint
- Number of treatment emergent adverse events
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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;
Arms & Interventions
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.
Intervention: SHR0534
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.
Intervention: Placebo
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.
Intervention: SHR0534
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.
Intervention: Placebo
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.
Intervention: SHR0534
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.
Intervention: Placebo
Outcomes
Primary Outcomes
Number of treatment emergent adverse events
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: From time 0 to 192 hours after the last dose
Changes in the concentrations of blood glucose and insulin after multiple oral dose
Time Frame: From baseline up to 24 hours after last treatment (Day 31)]