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

Phase 2CompletedNCT01984489

Jiangsu HengRui Medicine Co., Ltd.120 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Type 2 Diabetes

Interventions

PlaceboDRUG

SHR117887DRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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: \-

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

Time frame: 12 weeks

Change From Baseline in Fasting Plasma Glucose,insulin and C-peptide at Week 12

Time frame: 12 weeks

Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 12

Time frame: 12 weeks

Change From Baseline in Body Weight at Week 12

Time frame: 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.