Safety, Tolerability, Pharmacokinetics,Pharmacodynamics Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus

NCT01452451 · Completed

Last updated 2026-05-28

This clinical trial is testing the safety and tolerability of LAPS-Exendin in adults with type 2 diabetes.

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, triple-blind treatment study

Participants 72 people

Who can join Ages 18–65 · all sexes

Timeline Started 2011-12

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT01452451 ↗

Description as written by the study sponsor.

The purpose of this study is to investigate the safety and tolerability of repeated doses of HM11260C when given different regimens in subjects with type 2 diabetes mellitus (T2DM) on stable metformin monotherapy.

Treatments tested

HM11260C also known as LAPS-Exendin4 Drug

1, 2, and 4 mg for 8 weekly subcutaneous injections for cohorts W1, W2 and W3. 8, 12 and 16 mg for 3 monthly subcutaneous injections for cohorts M1, M2 and M3
Placebo Drug

Placebo for 8 weekly subcutaneous injections for cohorts W1, W2 and W3. Placebo for 3 monthly subcutaneous injections for for cohorts M1, M2 and M3

Main thing measured	Number of subjects with adverse events as a measure of safety and tolerability
Sponsor	Hanmi Pharmaceutical Company Limited
Conditions studied	Diabetes Mellitus
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01452451 ↗