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
Overview
- Phase
- Phase 3
- Intervention
- PEX168(100µg)
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Enrollment
- 587
- Locations
- 1
- Primary Endpoint
- HbA1c
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
PEX168(100µg)
PEX168,100µg,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.
Intervention: PEX168(100µg)
PEX168(100µg)
PEX168,100µg,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.
Intervention: Metformin
PEX168(200µg)
PEX168,200µg,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.
Intervention: PEX168(200µg)
PEX168(200µg)
PEX168,200µg,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.
Intervention: Metformin
Placebo
Placebo,0.5ml,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.
Intervention: Placebo
Placebo
Placebo,0.5ml,Subcutaneous injection,once a week. Metformin,0.5mg, tid,oral.
Intervention: Metformin
Outcomes
Primary Outcomes
HbA1c
Time Frame: 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 Outcomes
- The proportion of HbA1c <6.5% and <7% at the end of the analysis.(Baseline to Week24)
- Fasting plasma glucose(Baseline to Week52)
- 6 points glucose of fingertip(Baseline to Week52)
- 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)
- Blood pressure(Baseline to Week52)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Baseline to Week 56)