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
1 other identifier
interventional
120
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 type-2-diabetes
Started Jun 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 8, 2013
CompletedFirst Posted
Study publicly available on registry
November 14, 2013
CompletedNovember 19, 2013
November 1, 2013
11 months
November 8, 2013
November 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 12
12 weeks
Secondary Outcomes (4)
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
Study Arms (3)
Placebo/Metformin
PLACEBO COMPARATORpatients 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
EXPERIMENTALpatients 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
EXPERIMENTALpatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2013
First Posted
November 14, 2013
Study Start
June 1, 2012
Primary Completion
May 1, 2013
Study Completion
August 1, 2013
Last Updated
November 19, 2013
Record last verified: 2013-11