Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5730
Source ID: NCT02077452
Associated Drug: Hms5552
Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HMS5552 in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: HMS5552|DRUG: Placebo
Outcome Measures: Primary: Safety and tolerability of HMS5552 will be assessed by adverse event monitoring, physical examinations, 12 lead ECGs, vital sign, and safety laboratory measurements., up to 15 days after study drug administration | Secondary: The single dose and steady state pharmacokinetics (with food and fasting) of HMS5552 will be described by estimating parameters of AUCinf, AUC0-t, Cmax, Tmax, Ae, T1/2, CL/f, CLr/f, accumulation index and fluctuation index., 1. Single dose (Day 1) plasma and urine pharmacokinetic parameters (postprandial) 2. Single dose (Day 3) plasma and urine pharmacokinetic parameters (fasting) 3. Steady state (Day 7) plasma and urine pharmacokinetic parameters (postprandial) 4. Steady state (Day 8) plasma and urine pharmacokinetic parameters (fasting), up to day 8 post-dose|The single dose and steady state (fasting and postprandial) pharmacodynamic variables will include maximum absolute and percent change in plasma glucose level, AUC0-4, AUC0-16, AUC16-24, AUC0-24 hr of plasma glucose., up to 4 hour post-dose and up to 24 hour post-dose|Insulin, C-peptide, glucagon and glucagon-like peptide 1 up to 6hr post-dose following single dose and steady state (fasting and postprandial), up to 6 hour post-dose
Sponsor/Collaborators: Sponsor: Hua Medicine Limited
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 53
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-03
Completion Date: 2014-10
Results First Posted:
Last Update Posted: 2017-11-20
Locations:
URL: https://clinicaltrials.gov/show/NCT02077452