The Effectivity and Safety Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus

NCT03239119 · Unknown status

Last updated 2026-05-28

This clinical trial is testing the safety and effects of a new medication called rExenatide-4 in adults with type 2 diabetes in China.

Status Unknown status The sponsor has not confirmed the status recently.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 456 people Planned (estimated).

Who can join Ages 18–75 · all sexes

Timeline Started 2017-11 · est. completion 2019-01

What this study is testing ClinicalTrials.gov NCT03239119 ↗

Description as written by the study sponsor.

This research is a randomized, double-blind,controlled trial. 456 Chinese subjects with Type 2 Diabetes Mellitus will be enrolled in the trial.

rE-4 5 mcg also known as rExenatide-4 Biologic

Placebo Lead In (5 mcg) for 4 weeks / rE-4 5 mcg for 4 weeks / rE-4 5 mcg for 26 weeks - All are subcutaneously injected twice daily
rE-4 10 mcg also known as rExenatide-4 Biologic

Placebo Lead In (5 mcg) for 4 weeks / rE-4 5 mcg for 4 weeks / rE-4 10 mcg for 26 weeks - All are subcutaneously injected twice daily
Placebo 5 mcg Biologic

Placebo Lead In (5 mcg) for 4 weeks / Placebo 5 mcg for 4 weeks / Placebo 5 mcg for 26 weeks - All are subcutaneously injected twice daily
Placebo 10 mcg Biologic

Placebo Lead In (5 mcg) for 4 weeks / Placebo 5 mcg for 4 weeks / Placebo 10 mcg for 26 weeks - All are subcutaneously injected twice daily

Main thing measured	Change in HbA1c from Baseline to Week 30
Sponsor	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions studied	Type2 Diabetes Mellitus
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03239119 ↗