A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator on Gastric Emptying and Beta-Cell Response in Subjects with Type 2 Diabetes Mellitus
Primary Objective \- effect of multiple different weekly and monthly doses of HM11260C and liraglutide (Victoza) as active control on gastric emptying Secondary Objectives * evaluate the pharmacodynamic (PD) effects of multiple weekly and monthly doses of HM11260C and liraglutide after a Mixed Meal Tolerance Test * evaluate the islet β-cell function after a graded glucose infusion (GGI) of different doses of HM11260C and liraglutide * evaluate safety and tolerability of different doses of HM11260C and liraglutide * evaluate the pharmacokinetic (PK) effect of multiple weekly and monthly doses of HM11260C
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
Hanmi
California City, California, United States
RECRUITINGPK profile of acetaminophen
Cmax, AUC at 13 weeks
Time frame: 13 weeks
Glucose metabolism
Fasting plasma glucose (FPG), Postprandial glucose (PPG), Insulin, C-peptide, HbA1c at 13 weeks
Time frame: 13 weeks
Safety and tolerability
Incidence and severity of adverse events, findings on physical examination, clinical laboratory abnormalities at 18 weeks
Time frame: 18 weeks
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