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

Status Recruiting

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02059564
Study type	Interventional
Source	Hanmi Pharmaceutical Company Limited
Contact	Hanmi Clinical
Email	clinical4@hanmi.co.kr
Status	Recruiting
Phase	Phase 1
Start date	December 2013
Completion date	December 2014

View Details

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