A Multicenter Randomized, Double-blind, Placebo Controlled ,Parallel Group ,Phase II Study to Access the Efficacy and Safety of SHR117887 in Combination Therapy With Metformin in Patients With Type 2 Diabetes Patients
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Type 2 Diabetes
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrollment
- 120
- Primary Endpoint
- Change From Baseline in HbA1c (Hemoglobin A1C) at Week 12
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
SHR117887 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the efficacy and safety of SHR117887 in combination therapy with Metformin in patients with Type 2 Diabetes in Metformin monotherapy Who have Inadequate Glycemic Control
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients diagnosed with type 2 diabetes mellitus
- •Patients have been treated with metformin for at least 8 weeks and be on a stable dose of at least 1500mg daily prior to the screening visit
- •HbA1C：≥7.5% and ≤11.0% at screeing visit and at the end of run-in period
- •Age:≥20 and ≤70 years
- •BMI(body mass index):≥20 and ≤35 kg/m2
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo/Metformin
patients are administered oral tablets of placebo once daily and 500mg TID for 4 weeks at the run-in period. After randomized ,patients administer the drugs too.
Intervention: Placebo
SHR117887 (50mg q.d)/Metformin
patients are administered oral placebo once daily and metformin 500mg TID for 4 weeks at the run-in period.After randomised,patients adminitered SHR117887 50mg QD and metformin 500mg TID for 12 weeks.
Intervention: SHR117887
SHR117887 (100mg q.d)/Metformin
patients are administered oral placebo once daily and metformin 500mg TID for 4 weeks at the run-in period.After randomised,patients adminitered SHR117887 100mg QD and metformin 500mg TID for 12 weeks.
Intervention: SHR117887
Outcomes
Primary Outcomes
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 12
Time Frame: 12 weeks
Secondary Outcomes
- Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels(12 weeks)
- Change From Baseline in Fasting Plasma Glucose,insulin and C-peptide at Week 12(12 weeks)
- Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 12(12 weeks)
- Change From Baseline in Body Weight at Week 12(12 weeks)