Clinical Trial Details
| Trial ID: | L4607 |
| Source ID: | NCT01969318 |
| Associated Drug: | Placebo /Metformin |
| Title: | Efficacy and Safety Study of SP2086 in Combination With Metformin in Patients With Type 2 Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: Placebo /Metformin|DRUG: SP2086(50 mg q.d.)/Metformin|DRUG: SP2086 (100 mg q.d.)/Metformin |
| Outcome Measures: | Primary: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 12, 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 12, baseline, week 12|Change from baseline in Homeostasis model assessment-beta(HOMA-β) at week12, baseline, week 12|Change From Baseline in lipid at Week 12, baseline, week12|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: | 120 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION |
| Start Date: | 2012-03 |
| Completion Date: | 2012-11 |
| Results First Posted: | |
| Last Update Posted: | 2013-10-25 |
| Locations: | Chinese PLA General Hospital, Beijing, China |
| URL: | https://clinicaltrials.gov/show/NCT01969318 |
