Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
isophane human insulin · 2 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| Formulation A | EXPERIMENTAL | - |
| Formulation B | ACTIVE_COMPARATOR | - |
| Trial part 1 | EXPERIMENTAL | - |
| Trial part 2 | 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 |
| insulin degludec | DRUG | Ascending single doses - 5 dose levels. Escalation to next dose level will be performed following evaluation of safety data. |
| placebo | DRUG | Ascending single doses - 5 dose levels |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| FibroBiologics, Inc. | FBLG | 1 | PHASE1 | Undisclosed |
| MiMedx Group, Inc. | MDXG | 2 | N/A | Undisclosed |
| Integra LifeSciences Holdings Corporation | IART | 1 | N/A | Undisclosed |
| Organogenesis Holdings, Inc. Class A | ORGO | 1 | N/A | Undisclosed |
| Healthcare Services Group, Inc. | HCSG | 1 | N/A | Undisclosed |
Isophane human insulin is an investigational drug being developed for diabetes. It is a small molecule being studied in clinical trials for the treatment of diabetes, including type 1 and type 2 diabetes. The drug is currently in Phase 1 clinical development.
Isophane human insulin is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with diabetes.
Isophane human insulin is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied in early-stage clinical trials to assess its safety, tolerability, and pharmacokinetics.
Isophane human insulin has been studied in two completed Phase 1 clinical trials. One trial (NCT01486901) evaluated the bioequivalence of two Insulatard formulations in healthy subjects, while another trial (NCT01865279) assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of an explorative formulation of insulin degludec.
Isophane human insulin is associated with the Insulatard brand name, as one clinical trial (NCT01486901) compared two Insulatard formulations. However, the drug is also being studied in combination with insulin degludec, suggesting it may be part of a broader development program.