Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Actrapid HM · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | 56 subjects will receive metabolically active insulin by subcutaneous injections for 36 months (twice daily) |
| 2 | NO_INTERVENTION | - |
| Name | Type | Description |
|---|---|---|
| Actrapid HM | DRUG | 56 subjects will receive metabolically active insulin by subcutaneous injections for 36 months (twice daily) |
Inclusion Criteria: * Sibling/offspring of a Type 1 diabetic patient * in good general condition * age 5-39 years * fasting plasma glucose \<126 mg/dL AND an OGTT that is non-diabetic by 1997 ADA criteria (33): 1. Normal glycemia: * fasting plasma glucose \< 110 mg/dL and * 2 hour pla...
Actrapid HM is an investigational small molecule developed by Novo Nordisk A/S for the prevention of type 1 diabetes. It was studied in a Phase 2 trial in high risk first degree relatives of people with type 1 diabetes. It is not described as approved and remains in clinical development.
Actrapid HM was studied for the prevention of clinical onset of type 1 diabetes in high risk first degree relatives. The Phase 2 trial enrolled 112 participants aged 5 years and older in Belgium, including healthy volunteers. The study is completed and no active trials are ongoing.
Actrapid HM is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor associated with the Phase 2 study of Actrapid HM in type 1 diabetes prevention.
Actrapid HM is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The program studied prevention of clinical onset of type 1 diabetes in high risk first degree relatives.
Actrapid HM has been studied in one completed Phase 2 trial, NCT00654121, titled Prevention of Clinical Onset of Type 1 Diabetes in High Risk First Degree Relatives. The trial enrolled 112 participants in Belgium, included healthy volunteers, and used an active-controlled design without randomization or double blinding.