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isophane human insulin · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Formulation A | EXPERIMENTAL | - |
| Formulation B | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| isophane human insulin | DRUG | Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits |
Inclusion Criteria: * Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator * Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2, inclusive * Non-smoker, defined as no nicotine consumption for at least one year * Fasting plasma gluco...
Isophane human insulin is an insulin product developed for the treatment of diabetes. It is an intermediate-acting insulin formulation. Novo Nordisk A/S is developing it, and clinical testing has focused on diabetes and healthy volunteer studies. It is intended to help manage blood glucose levels in people with diabetes.
Isophane human insulin targets the insulin receptor, INSR, where it acts as an agonist. By binding to and activating INSR, it mimics the action of endogenous insulin to promote glucose uptake and lower blood glucose. This receptor-mediated mechanism underlies its use in diabetes management.
Isophane human insulin is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the company responsible for the development of this insulin formulation. The drug is part of its metabolic and diabetes portfolio.
Isophane human insulin is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 program has completed one trial, and no active trials are currently listed. Further clinical development would be required before any regulatory approval.
Isophane human insulin has been studied in one completed Phase 1 trial, NCT01486901, titled Bioequivalence of Two Insulatard Formulations in Healthy Subjects. The trial enrolled 44 participants in Germany, was randomized, double-blind, and active-controlled, and included subjects with diabetes and healthy volunteers.