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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01984489
• Other study ID #: SHR117887-201
• Status: Completed
• Phase: Phase 2
• First received: November 8, 2013
• Last updated: November 18, 2013
• Start date: June 2012
• Est. completion date: August 2013

Study information

• Verified date: November 2013
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Placebo

• SHR117887

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HbA1c (Hemoglobin A1C) at Week 12		12 weeks	No
Secondary	Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels		12 weeks	No
Secondary	Change From Baseline in Fasting Plasma Glucose,insulin and C-peptide at Week 12		12 weeks	No
Secondary	Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 12		12 weeks	No
Secondary	Change From Baseline in Body Weight at Week 12		12 weeks	No