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

Phase 3

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: PEX168(100µg); Drug: PEX168(200µg); Drug: Metformin

• Registration Number: NCT02477969
• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Brief 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.

Study Timeline

• Study Start: 2014-02-27
• Study First Submitted: 2015-05-30
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-23
• Status Verified: 2016-01
• Primary Completion: 2016-06-22
• Last Update Submitted: 2017-01-21
• Last Update Posted: 2017-01-24
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 587

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo,0.5ml,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.
PEX168(100µg)	PEX168(100µg)	PEX168,100µg,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.
PEX168(200µg)	PEX168(200µg)	PEX168,200µg,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.
PEX168(200µg)	Metformin	PEX168,200µg,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.
PEX168(100µg)	Metformin	PEX168,100µg,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.
Placebo	Metformin	Placebo,0.5ml,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.

Primary Outcome Measures

Name	Time	Method
HbA1c	Baseline to Week24	HbA1c change from baseline to treatment Week 24 when receiving PEX 168 combined with metformin hydrochloride as compared to the placebo combined with metformin hydrochloride；PEX 168 as compared to the placebo, given on the basis of diet control and exercise.

Secondary Outcome Measures

Name	Time	Method
The proportion of HbA1c <6.5% and <7% at the end of the analysis.	Baseline to Week24	The proportion of HbA1c \<6.5% and \<7% at the end of the analysis, and the proportion receiving salvage therapy.
Fasting plasma glucose	Baseline to Week52
6 points glucose of fingertip	Baseline to Week52	Each test point of time was before breakfast, 2 hours after breakfast, before lunch,2 hours after lunch , dinner, 2 hours after dinner.This test was performed four times including baseline,V19,V31 and V59.
Postprandial blood glucose two hours	Baseline to Week52
Postprandial blood glucose two hours AUC	Baseline to Week52
Lipid	Baseline to Week52
Weight measured by standardized procedure.	Baseline to Week52	Collect weight data in the morning of screening period, baseline,4,8,12,18,24,38,52 weeks by standardized procedure.
Blood pressure	Baseline to Week52	Collect blood pressure data in the morning of screening period, baseline,4,8,12,18,24,38,52 weeks by standardized procedure.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Baseline to Week 56

Trial Locations

Locations (1)

Shanghai sixth People's Hospital; 🇨🇳 Shanghai, Shanghai, China