NCT02059564

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed description

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

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	HM11260C	doses of 6 mg, 16 mg
DRUG	Placebo	Normal saline solution
DRUG	Victoza	doses of 1.8 mg

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2014-02-11
• Last updated: 2014-02-11

Locations

1 site across 1 country: United States