Efficacy and Safety Study of SHR117887 in Combination With Metformin in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Placebo
* Drug: SHR117887


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo/Metformin<br>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. | Drug: Placebo<br> <br> |
| Experimental: SHR117887 (50mg q.d)/Metformin<br>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. | Drug: SHR117887<br> <br> |
| Experimental: SHR117887 (100mg q.d)/Metformin<br>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. | Drug: SHR117887<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c (Hemoglobin A1C) at Week 12 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SHR117887, Metformin,combination,PhaseII