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Clinical Trial Details

Trial ID: L7170
Source ID: NCT01970033
Associated Drug: Placebo
Title: Efficacy and Safety of SP2086 as Monotherapy in Patients With Type 2 Diabetes
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Placebo|DRUG: SP2086 50 mg b.i.d.|DRUG: SP2086 100 mg q.d.
Outcome Measures: Primary: Change From Baseline in HbA1c (Hemoglobin A1C) at Week24, A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent, baseline, week 24 | Secondary: Change From Baseline in fasting plasma glucose (FPG) at Week 24, Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG, Weeks 0-24|Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24, Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG, Weeks 0-24|Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels, week24|Change From Baseline in A1C at Week 52, A1C is measured as a percent. Thus, this change from baseline reflects the Week 52 A1C percent minus the Week 0 A1C percent, week 52|Change From Baseline in FPG at Week 52, Change from baseline at Week 52 is defined as Week 104 FPG minus Week 0 FPG, week 52|Change From Baseline in lipid at Week 4、8、12、24、38、52, Week 4、8、12、24、38、52|Change From Baseline in Body Weight at Week 4,8,12、24、38、52, Week 4、8、12、24、38、52
Sponsor/Collaborators: Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 450
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2012-12
Completion Date: 2015-01
Results First Posted:
Last Update Posted: 2013-10-25
Locations: Chinese PLA General Hospital, Beijing, China
URL: https://clinicaltrials.gov/show/NCT01970033