Clinical Trial Details
| Trial ID: | L3527 |
| Source ID: | NCT01630369 |
| Associated Drug: | Insulin Human (Hr1799) |
| Title: | Efficacy and Safety of Insuman Basal/Comb/Rapid in Patients With Type 2 Diabetes |
| Acronym: | SPIRIT |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: insulin human (HR1799) |
| Outcome Measures: | Primary: Decrease of Hb A1c ≥ 1%, Baseline, 6 months | Secondary: Percentage of patients with Hb A1c < 7.5%, 6 months|Rate of hypoglycaemias (symptomatic, severe), 6 months|Middle dose of insulin per product (Insuman Basal, Insuman Comb, Insuman Rapid), 6 months|Change in FPG, Baseline 6 months|Number of patients with adverse events, 6 months|Assessment of efficacy of education courses in Diabetes Schools, Percentage of correct answers after second test compare to the testing of the initial level, Baseline, 6 months |
| Sponsor/Collaborators: | Sponsor: Sanofi |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 552 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2012-02 |
| Completion Date: | 2013-05 |
| Results First Posted: | |
| Last Update Posted: | 2014-05-19 |
| Locations: | Sanofi-Aventis Administrative Office, Kyiv, Ukraine |
| URL: | https://clinicaltrials.gov/show/NCT01630369 |
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