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

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited
• Treatments: Exenatide; Liraglutide

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