NCT02477969

Efficacy and Safety Study of PEX168 in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Study Evaluating PEGylated Loxenatide Injection（PEX168）Combined With Metformin in the Treatment of Type 2 Diabetes Mellitus

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 587 (actual)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study that will enroll approximately 564 T2DM patients who before screening have inadequately controlled blood glucose （7.0%≤HbA1c≤10.5% at randomization）despite at least 8 weeks of metformin monotherapy at stable doses（≥1500 mg/day).

Detailed description

Subjects will be randomized to receive either PEX168 100μg, 200μg or PEX 168 Dummy Injection as add-on to metformin hydrochloride. The baseline HbA1c level （HbA1c≤8.5% or HbA1c\>8.5）is designed as the stratification factor based on which a dynamic randomization will be performed. This study consists of 4 periods： Period 1：Up to 3 weeks of screening period. Period 2：A 4-week PEX168 dummy injection 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 30-day safety follow-up period.

Conditions

• Type 2 Diabetes Mellitus

Interventions

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

Timeline

• Start date: 2014-02-27
• Primary completion: 2016-06-22
• Completion: 2017-06-01
• First posted: 2015-06-23
• Last updated: 2017-01-24

Locations

1 site across 1 country: China