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

Launched by HANMI PHARMACEUTICAL COMPANY LIMITED · Feb 7, 2014

Keywords

ClinConnect Summary

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 do...

Gender

ALL

Eligibility criteria

• 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