Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Humulin R, RHI, Humulin
Regular Human Insulin · 2 trials · 2 indications
A 2-hour postprandial glucose excursion was measured for 3 meals over 3 days during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle). For each of the 3 days, the mealtime (breakfast, lunch, and dinner) excursions were calculated as the post-meal glucose value minus the pre-meal value as determined by 8-point glucose monitoring. The average of all excursions over the 3 days for the corresponding treatment cycle is presented.
Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); and every 5 mins (from 15 to 30 mins) after each injection. The percent coefficient of variation (CV%) was calculated as 100\*(standard deviation/mean). The intra-participant CV% was calculated directly from the 2 replications of each treatment. The CV% for percentage of total AUC is reported from 0 to 30 minutes.
| Arm | Type | Description |
|---|---|---|
| INSULIN-PH20 NP / Insulin Lispro | EXPERIMENTAL | All enrolled participants underwent a 1-month dose titration period and received 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC) pre-meals, with doses titrated to each participant individually. Next participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle. INSULIN-PH20 NP (Treatment A): 100 U/mL non-preserved (NP) formulation of regular human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, doses titrated to each participant individually. Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, doses titrated to each participant individually. Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine or maintained their usual regimen through an insulin pump. |
| Insulin Lispro, Regular Human Insulin, rHuPH20 | EXPERIMENTAL | All participants were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C). Intervention A: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20) Intervention B: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20 Intervention C: a single, SC injection of 0.15 U/kg insulin lispro alone There was a washout period of 3 to 14 days between interventions. The treatment sequence (ABC, ACB, BAC, BCA, CAB, or CBA) was repeated once so that each participant received up to 6 injections. |
| Name | Type | Description |
|---|---|---|
| Insulin Lispro | DRUG | - |
| regular human insulin | DRUG | - |
| recombinant human hyaluronidase PH20 | DRUG | - |
| Insulin glargine | DRUG | - |
| rHuPH20 | DRUG | - |
Inclusion Criteria: * Male or female of age 18 to 65 years, inclusive. Females of child-bearing potential must use a standard and effective means of birth control for the duration of the study. * Participants with Type 1 diabetes mellitus (T1DM) (per World Health Organization \[WHO\] criteria) trea...
Regular Human Insulin is used for Diabetes Mellitus, including Type 1 Diabetes Mellitus. It is being studied in combination with recombinant human hyaluronidase (rHuPH20) for subcutaneous administration. The drug is in clinical development for metabolic conditions.
Regular Human Insulin is being developed by Halozyme Therapeutics, Inc., a company traded on the NASDAQ under the ticker symbol HALO. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics.
Regular Human Insulin is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to assess its safety and efficacy in patients with diabetes.
Regular Human Insulin has been studied in clinical trials including NCT00862849, a Phase 1 pharmacokinetic and glucodynamic crossover study, and NCT00883558, a Phase 2 safety study in Type 1 diabetes. Both trials have been completed.
No, Regular Human Insulin is not the same as Insulin Lispro. They are different insulin formulations. However, clinical trials have compared Regular Human Insulin combined with rHuPH20 against Insulin Lispro alone to evaluate their pharmacokinetic and glucodynamic profiles.