Clinical Trial Details
| Trial ID: | L7168 |
| Source ID: | NCT01676233 |
| Associated Drug: | Insulin Glargine (Hoe901) |
| Title: | Repeated Dose Study With a New Insulin Glargine Formulation and Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 1 Diabetes Mellitus |
| Interventions: | DRUG: insulin glargine (HOE901)|DRUG: insulin glargine- new formulation (HOE901) |
| Outcome Measures: | Primary: Change in 24-hour blood glucose profile measured by continuous glucose monitoring, Baseline, Day 28, Day 56 | Secondary: Hypoglycemia categorized by the definition of American Diabetes Association, Up to Day 56|Change in fasting plasma glucose from baseline to each treatment end by treatment, Baseline, Day 28, Day 56|Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment, Baseline, Day 28, Day 56|Change in HbA1c from baseline to each treatment end by treatment, Baseline, Day 28, Day 56 |
| Sponsor/Collaborators: | Sponsor: Sanofi |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 20 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2012-09 |
| Completion Date: | 2013-08 |
| Results First Posted: | |
| Last Update Posted: | 2013-08-19 |
| Locations: | Investigational Site Number 392001, Kumamoto-Shi, Japan |
| URL: | https://clinicaltrials.gov/show/NCT01676233 |
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