A Phase 1, Randomized, Placebo-controlled, Multiple Dose Escalation Study to Investigate Safety, Pharmacokinetics, and Pharmacodynamics of SHR0534 in Chinese Type 2 Diabetic Patients

Type 2 Diabetic Patients Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03006159
• Other study ID #: SHR0534-Ib
• Status: Completed
• Phase: Phase 1
• First received: December 28, 2016
• Last updated: December 28, 2016
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: December 2016
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetic Patients

Intervention

Drug:
• SHR0534

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent adverse events		From baseline up to 8 days after last treatment (Day 38)	Yes
Primary	Area under the plasma concentration curve after the first and last multiple oral dose (AUC)		From time 0 to 24 hours for the first dose, and from time 0 to 192 hours after the last dose	No
Primary	Peak plasma concentration (Cmax) after the first and last multiple oral dose		From time 0 to 24 hours for the first dose, and from time 0 to 192 hours after the last dose	No
Primary	Terminal elimination halflife (t½) for SHR0534 after the last multiple oral dose		From time 0 to 192 hours after the last dose	No
Primary	Changes in the concentrations of blood glucose and insulin after multiple oral dose		From baseline up to 24 hours after last treatment (Day 31)]	No