A Phase 1b Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus

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

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

Inclusion Criteria:

• Adults ≥18 to ≤ 70 years of age at the time of the Screening Visit
• History of type 2 diabetes
• Body mass index (BMI) ≥18 to ≤45 kg/m2 at the Screening Visit
• Use of approved methods of contraception
• Ability to provide written informed consent

Exclusion Criteria:

• Type 1 diabetes
• Significant acute diabetic proliferative retinopathy or severe neuropathy
• Systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg at screening
• Pregnant or lactating women
• Participation in an investigational study within 30 days prior to randomization
• History of any major surgery within 6 months prior to Screening
• History of any serious adverse reaction or hypersensitivity to any of the product components.
• History of renal disease or significantly abnormal kidney function tests at Screening
• History of hepatic disease or significantly abnormal liver function tests
• History of any active infection within 30 days prior to Randomization
• Presence of clinically significant physical, laboratory, or ECG findings at Screening that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results
• Concurrent conditions that could interfere with safety and/or tolerability measurements per the investigator
• Donation or loss of >500 mL of blood or blood product within 56 days of Randomization