Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
insulin glargine U200 HOE901 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| insulin glargine U100 | ACTIVE_COMPARATOR | 1 single dose |
| insulin glargine U200 | EXPERIMENTAL | 1 single dose |
| insulin glargine U500 | EXPERIMENTAL | 1 single dose |
| Name | Type | Description |
|---|---|---|
| insulin glargine U200 HOE901 | DRUG | Pharmaceutical form:solution for injection Route of administration: subcutaneous |
| insulin glargine U500 HOE901 | DRUG | Pharmaceutical form:solution for injection Route of administration: subcutaneous |
| insulin glargine U100 HOE901 | DRUG | Pharmaceutical form:solution for injection Route of administration: subcutaneous |
Inclusion criteria: * Male or female subjects, between 18 and 65 years of age, inclusive, with type 1 diabetes mellitus for more than one year, as defined by the American Diabetes Association. * Total insulin dose \<1.2 U/kg/day. * Minimum usual basal insulin dose ≥0.2 U/kg/day. * Body weight betwe...
Insulin glargine U200 HOE901 is being studied for the treatment of Type 1 Diabetes Mellitus. It is a concentrated formulation of insulin glargine developed by Sanofi. The investigational product is designed to provide basal insulin coverage in people with Type 1 Diabetes Mellitus.
Insulin glargine U200 HOE901 targets the insulin receptor, INSR. It acts as an agonist at this receptor. By binding to and activating INSR, the drug is designed to mimic the metabolic actions of endogenous insulin in patients with Type 1 Diabetes Mellitus.
Insulin glargine U200 HOE901 is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating this concentrated insulin glargine formulation for Type 1 Diabetes Mellitus.
Insulin glargine U200 HOE901 is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 1 program has completed one trial, and no active trials are currently listed.
Insulin glargine U200 HOE901 has been evaluated in one completed Phase 1 trial, NCT02201199. This single dose clamp study compared the concentration/time profile and metabolic activity profile of two new insulin glargine formulations with Lantus in 36 participants with Type 1 Diabetes Mellitus in Germany.
Insulin glargine U200 HOE901 is a distinct concentrated formulation of insulin glargine, not the same as Lantus. The Phase 1 trial NCT02201199 compared two new insulin glargine formulations against Lantus, which served as the active control in that study.