Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NPH insulin · 3 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Insulin glargine | EXPERIMENTAL | injection once daily at bedtime |
| NPH insulin | ACTIVE_COMPARATOR | injection once daily at bedtime or twice daily in the morning and at bedtime |
| Insulin Glulisine | EXPERIMENTAL | Insulin Glulisine (100UI/ml), at least twice daily, in association with basal insulin therapy (NPH insulin or insulin glargine for a maximum of 26 weeks |
| Insulin Lispro | ACTIVE_COMPARATOR | Insulin Lispro (100UI/ml) Subcutaneous (SC) injection , at least twice daily, in association with basal insulin therapy (NPH insulin or insulin glargine ) for a maximum of 30 weeks |
| Insulin glulisine (U300) - Test formulation | EXPERIMENTAL | Insulin glulisine (U300) will be given as a single subcutaneous (SC) dose on Day 1 of each period under fasting conditions according to the random list and assigned sequence. Glucose, insulin aspart (IV) and heparin will be used for clamp procedure. NPH insulin (if necessary) and insulin aspart (SC) will be handed out at screening to change insulin regimen and glucagon at Day 1 to treat cases of severe hypoglycemia. |
| Insulin glulisine - Reference formulation | ACTIVE_COMPARATOR | Insulin glulisine (U100) will be given as a single SC dose on Day 1 of each period under fasting conditions according to the random list and assigned sequence. Glucose, insulin aspart (IV) and heparin will be used for clamp procedure. NPH insulin (if necessary) and insulin aspart (SC) will be handed out at screening to change insulin regimen and glucagon at Day 1 to treat cases of severe hypoglycemia. |
| Name | Type | Description |
|---|---|---|
| Insulin glargine (HOE901) | DRUG | Pharmaceutical form:aqueous solution for injection Route of administration: Subcutaneous |
| NPH insulin | DRUG | Pharmaceutical form:aqueous solution for injection Route of administration: Subcutaneous |
| Insulin glulisine | DRUG | Subcutaneous injection |
| insulin lispro | DRUG | Subcutaneous injection |
| insulin glargine | DRUG | Subcutaneous injection once daily |
| Insulin glulisine (U300) | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Insulin aspart | DRUG | Pharmaceutical form: solution Route of administration: intravenous/subcutaneous |
| Glucagon | DRUG | Pharmaceutical form: Powder and solvent for solution for injection Route of administration: subcutaneous |
| Glucose | DRUG | Pharmaceutical form: solution Route of administration: intravenous |
| Heparin | DRUG | Pharmaceutical form: solution Route of administration: intravenous |
Inclusion criteria: \- Paediatric patients diagnosed with T1DM aged at least 6 years to less than 18 years at screening. Exclusion criteria: * Treatment with oral or parenteral glucose-lowering medications other than insulin. * HbA1c \< 7% or \> 12 % at screening. The above information is not in...
NPH insulin is an intermediate-acting insulin used to control blood sugar in people with diabetes mellitus, including insulin-dependent diabetes and type 1 diabetes mellitus. It is typically given by injection to help manage glucose levels in both children and adults.
NPH insulin is developed by Sanofi, a global biopharmaceutical company traded on the stock exchange under the ticker symbol SNY. Sanofi is responsible for the clinical development and manufacturing of this insulin product.
NPH insulin is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trials are completed, and the drug is being studied for use in type 1 diabetes mellitus.
NPH insulin has been studied in several clinical trials, including NCT00115570, which compared glulisine with lispro in children and adolescents with type 1 diabetes, and NCT01223131, which evaluated insulin glargine versus NPH insulin in children with type 1 diabetes. Both trials were Phase 3 and completed.
No, NPH insulin is not the same as insulin glargine. They are different types of insulin. NPH insulin is an intermediate-acting insulin, while insulin glargine is a long-acting insulin. They were compared in a clinical trial (NCT01223131) to assess their efficacy and safety in children with type 1 diabetes.
NPH insulin is a type of insulin that helps regulate blood sugar levels by replacing the insulin that the body normally produces. It is an intermediate-acting insulin, meaning it works over a longer period compared to rapid-acting insulins, helping to control blood glucose between meals and overnight.