Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
insulin NPH · 3 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Rep + NPH | EXPERIMENTAL | - |
| NPH | ACTIVE_COMPARATOR | - |
| A | ACTIVE_COMPARATOR | - |
| B | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| repaglinide | DRUG | 2 mg at each main meal |
| insulin NPH | DRUG | Administrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner. |
| human insulin | DRUG | - |
| insulin aspart | DRUG | - |
| EX1000 | DRUG | "Soft-treat-to-target" dose titration scheme, injection s.c. |
Inclusion Criteria: * Type 2 diabetes * HbA1c (glycosylated haemoglobin): 7-13% (both inclusive) * BMI (body mass index) maximum 35 kg/m\^2
Insulin NPH is used to treat diabetes, including type 2 diabetes and gestational diabetes. It is an intermediate-acting insulin formulation studied both as a standalone therapy and in combination with other glucose-lowering agents such as repaglinide. Clinical trials have enrolled adults aged 18 years and older.
Insulin NPH targets INSR, the insulin receptor, acting as an agonist. By binding and activating this receptor, it supports glucose uptake and helps lower blood glucose levels in people with diabetes. This receptor-mediated mechanism underlies its use as a basal insulin therapy.
Insulin NPH is developed by Novo Nordisk A/S, which trades under the ticker NVO. The company has sponsored the clinical trials evaluating the drug in diabetes populations, including studies in type 2 diabetes and gestational diabetes.
Insulin NPH has been studied in Phase 3 clinical development for diabetes, with additional Phase 2 evaluation. It is an investigational therapy in the trials described here rather than a newly approved product, and all three listed trials have been completed.
Three completed trials have evaluated insulin NPH: NCT01562561 tested repaglinide combined with insulin NPH in type 2 diabetes, NCT00660374 compared insulin NPH with a new insulin formulation in type 2 diabetes, and NCT00065130 compared insulin aspart with regular human insulin in gestational diabetes.
The three completed insulin NPH trials enrolled a total of 642 participants. NCT00660374 was the largest with 402 participants, followed by NCT01562561 with 213 and NCT00065130 with 27. The studies were randomized and used active-controlled designs.