Clinical Trial Details
| Trial ID: | L3058 |
| Source ID: | NCT01969357 |
| Associated Drug: | Placebo |
| Title: | A Study of the Effectiveness and Safety of SP2086 to Treat Type 2 Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: Placebo|DRUG: 50 mg SP2086|DRUG: 100 mg SP2086|DRUG: 200 mg SP2086|DRUG: 100 mg Sitagliptin |
| Outcome Measures: | Primary: the change from baseline in HbA1c at 12 week, baseline, week 12 | Secondary: Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels, week 12|Change From Baseline in Fasting Plasma Glucose at Week 4, 8 and 12, Baseline, Week 4, 8, 12|Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 4 ,12, baseline, week 4 ,12|Change from baseline in Homeostasis model assessment-beta(HOMA-β) at week 4,week12, baseline, week 4,12week|Change From Baseline in lipid at Week 4, 8 and 12, baseline, week 4, 8, 12|Change From Baseline in Body Weight at Week 4,8,12, baseline, Week 4, 8,12 |
| Sponsor/Collaborators: | Sponsor: Jiangsu HengRui Medicine Co., Ltd. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 200 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2011-06 |
| Completion Date: | 2012-06 |
| Results First Posted: | |
| Last Update Posted: | 2013-10-25 |
| Locations: | Chinese PLA General Hospital, Beijing, China |
| URL: | https://clinicaltrials.gov/show/NCT01969357 |
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