Efficacy and Safety Study of PEX168 in Monotherapy Diabetes Mellitus Type 2 Patients
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: PlaceboDrug: PEX168(100µg)Drug: PEX168(200µg)
- Registration Number
- NCT02477865
- Lead Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 406
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo,0.5ml,Subcutaneous injection,once a week for 24 weeks,followed by PEX168(100µg or 200µg) qw sc for 28 weeks. PEX168(100µg) PEX168(100µg) PEX168(100µg),100µg,Subcutaneous injection,once a week,for 52 weeks. PEX168(200µg) PEX168(200µg) PEX168(200µg),200µg,Subcutaneous injection,once a week,for 52 weeks.
- Primary Outcome Measures
Name Time Method HbA1c Baseling to 24 weeks To evaluate the HbA1c change from baseline to treatment Week 24 when receiving 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. Baseling to 24 weeks The proportion of HbA1c \<6.5% and \<7% at the end of the analysis, and the proportion receiving salvage therapy.
Fasting plasma glucose Baseling to 52 weeks 6 points glucose of fingertip Baseling to 24 and 52 weeks 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 Baseling to 24 weeks Postprandial blood glucose two hours AUC Baseling to 24 weeks Lipid Baseling to 52 weeks Weight measured by standardized procedure. Baseling to 52 weeks Collect weight data in the morning of screening period, baseline,4,8,12,18,24,38,52 weeks by standardized procedure.
Blood pressure Baseling to 52 weeks 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 Baseling to 56 weeks