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
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2012-06-30
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
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Placebo
SHR117887
Eligibility Criteria
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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
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Other Identifiers
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SHR117887-201
Identifier Type: -
Identifier Source: org_study_id
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