Efficacy and Safety Study of SHR117887 in Combination With Metformin in Patients With Type 2 Diabetes
NCT ID: NCT01984489
Last Updated: 2013-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2012-06-30
2013-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo/Metformin
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.
Placebo
SHR117887 (50mg q.d)/Metformin
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
SHR117887 (100mg q.d)/Metformin
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.
SHR117887
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
SHR117887
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
20 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SHR117887-201
Identifier Type: -
Identifier Source: org_study_id