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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01984489

Enrollment

120

Registered

2013-11-14

Start date

2012-06-30

Completion date

2013-08-31

Last updated

2013-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

SHR117887, Metformin,combination,PhaseII

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

Interventions

DRUGPlacebo

DRUGSHR117887

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 12	12 weeks

Secondary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026