Clinical Trial Details
| Trial ID: | L7133 |
| Source ID: | NCT01461577 |
| Associated Drug: | Insulin Glargine Hoe 901 |
| Title: | Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) Failure |
| Acronym: | GAUDI |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: INSULIN GLARGINE HOE 901 |
| Outcome Measures: | Primary: Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline, 24 weeks | Secondary: Responder rate (HbA1c levels <7%) without severe hypoglycemia, 24 weeks|Responder rate (HbA1c levels <6.5% and <7%), 24 weeks|Changes of fasting plasma glucose (FPG) levels from baseline, 24 weeks|Changes of beta cell marker: C-peptide from baseline, 24 weeks|Changes of Lipid profile: Lipid profile from baseline, 24 weeks|Weight change from baseline, 24 weeks|Total insulin dose (per kg body weight), 24 weeks|Evaluation of patient's treatment satisfaction, 24 weeks|Number of patients with hypoglycemia, up to 24 weeks|Number of patients with treatment-emergent adverse events, up to 24 weeks |
| Sponsor/Collaborators: | Sponsor: Sanofi |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 89 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2011-11 |
| Completion Date: | 2012-12 |
| Results First Posted: | |
| Last Update Posted: | 2013-01-30 |
| Locations: | Administrative office, Tokyo, Japan |
| URL: | https://clinicaltrials.gov/show/NCT01461577 |
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