Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01053728 | Study of How Single Rising Doses of SAR161271 Are Absorbed and Act in Patients With Type 1 Diabetes Mellitus (T1DM) | PHASE1 | COMPLETED | 46 | — | — | Feb 1, 2010 | Nov 1, 2010 | Jul 26, 2011 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 : SAR161271 0.3 U/kg | EXPERIMENTAL | Cross-over design of four formulation of SAR161271 0.3U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp |
| Cohort 2 : SAR161271 0.6 U/kg | EXPERIMENTAL | Cross-over design of four formulation of SAR161271 0.6U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp |
| Cohort 3 : SAR161271 1.2 U/kg | EXPERIMENTAL | Cross-over design of four formulation of SAR161271 1.2 U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp |
| Name | Type | Description |
|---|---|---|
| SAR161271 | DRUG | Pharmaceutical form:Solution for injection Route of administration: subcutaneous |
| Insulin glargine HOE901 | DRUG | Pharmaceutical form:Solution for injection Route of administration: subcutaneous |
Inclusion criteria: * Patients who have type 1 diabetes mellitus (T1DM) as defined by American Diabetes Association average total insulin dose of \<1.2 U/kg/day * Fasting negative serum C-peptide (\<0.3 nmol/L) * Glycated hemoglobin (HbA1c) \< or = 9% * Stable insulin regimen for at least 2 months ...