A Phase 1b Study of LAPS-Exendin in Subjects of 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