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

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Placebo; Drug: SHR117887

• Registration Number: NCT01984489
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2013-05
• Study Completion: 2013-08
• Status Verified: 2013-11
• Study First Submitted: 2013-11-08
• Study First Submitted QC: 2013-11-08
• Study First Posted: 2013-11-14
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo/Metformin	Placebo	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.
SHR117887 (50mg q.d)/Metformin	SHR117887	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.
SHR117887 (100mg q.d)/Metformin	SHR117887	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 12	12 weeks

Secondary Outcome Measures

Name	Time	Method
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