NCT02077452

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HMS5552 in Patients With Type 2 Diabetes

A Randomized, Double-blinded, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of HMS5552 in Adult Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Hua Medicine Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of HMS5552 following multiple ascending doses in patients with type 2 diabetes mellitus.

Detailed description

This will be a randomized, double-blind and placebo-controlled study with multiple oral doses of HMS5552 given to patients with type 2 diabetes mellitus who never accepted anti-diabetic drug for treatment before. The primary objective is to characterize the safety and tolerability of HMS5552 following multiple ascending doses in patients with type 2 diabetes mellitus after BID dosing for 8 days. The secondary objectives include: 1. To determine the single dose and steady state pharmacokinetics of HMS5552 in patients with type 2 diabetes 2. To evaluate the single dose and steady state pharmacodynamics of HMS5552 in patients with type 2 diabetes 3. To further explore food-effect on HMS5552 pharmacokinetics and pharmacodynamics A maximum total of 80 patients (10 in each dose group and assuming a maximum of 5\~8 dose levels). There will be 8 active and 2 placebo patients in each dose group. The safety, tolerability, pharmacokinetics and pharmacodynamics data after each dose cohort will be reviewed in blinded fashion before escalation to the next dose cohort.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	HMS5552
DRUG	Placebo

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-09-01
• Completion: 2014-10-01
• First posted: 2014-03-04
• Last updated: 2017-11-20