NCT02477865

Efficacy and Safety Study of PEX168 in Monotherapy Diabetes Mellitus Type 2 Patients

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IIIa Clinical Study Evaluating PEGylated Loxenatide Injection（PEX168）in Monotherapy of Type 2 Diabetes Mellitus

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 406 (actual)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III, multicenter, randomized, double-blind, placebo-controlled study planning to include approximately 387 T2DM patients who have received at least 8 weeks of treatment with diet control and exercise； have not received any glucose-lowering agents within the 8 weeks prior to screening; and have inadequately controlled blood glucose.The subjects would receive PEX168 or placebo monotherapy for 52weeks in total.

Detailed description

This study consists of 4 periods： Period 1：Up to 3 weeks of screening period. Period 2：A 4-week PEX168 dummy run-in period. Period 3：A 52-week treatment period (including a 24-week core treatment period and a 28-week extended treatment period). Period 4: A 4-week safety follow-up period. This study will last for approximately 63 weeks, including up to approximately 60 clinic visits.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	PEX168(100µg)	100µg,Subcutaneous injection,once a week. continued for 52 weeks
DRUG	PEX168(200µg)	200µg,Subcutaneous injection,once a week. continued for 52 weeks
DRUG	Placebo	0.5ml,Subcutaneous injection,once a week.continued for 24 weeks,then use PEX168 100µg or 200µg qw sc.for 28 weeks.

Timeline

• Start date: 2014-03-23
• Primary completion: 2016-05-15
• Completion: 2017-02-01
• First posted: 2015-06-23
• Last updated: 2017-01-24