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Also known as Human Insulin Inhalation Powder, human insulin inhalation powder (HIIP)
Human Insulin · 9 trials · 5 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 4 week pretreatment phase consists of continuation of usual OAM therapy 24 week treatment period with insulin glargine and OAM continuation followed by 24 week treatment period with HIIP and OAM continuation 8 week follow up period |
| 2 | EXPERIMENTAL | 4 week pretreatment phase consists of continuation of usual OAM therapy 24 week treatment period with HIIP and OAM continuation followed by 24 week treatment period with insulin glargine and OAM continuation 8 week follow up period |
| 3 | EXPERIMENTAL | Intensified Glargine plus HIIP |
| A | EXPERIMENTAL | - |
| B | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Human Insulin Inhalation Powder | DRUG | patient specific dose, inhaled, before meals, 24 weeks |
| Insulin Glargine | DRUG | patient specific dose, injectable, before meals, 24 weeks |
| Injectable insulin | DRUG | patient specific dose, injected, before meals, 6 months |
| Insulin | DRUG | patient specific dose, oral or injectable, before meals and/or as needed, 9 months. ( patients and investigator determine standard option therapy) |
| injected insulin | DRUG | patient specific dose, injected, before meals, 12 months. |
| Neutral protamine hagedorn insulin | DRUG | patient specific dose, injected, daily, 76 weeks |
| human insulin inhalation powder (HIIP) | DRUG | * Administer HIIP within 15 minutes before meals. * Administer doses in one-capsule increments equivalent to approximately 2 IU or 6 IU of subcutaneous insulin. * Target treatment goals during the treatment sequence are the same as for patients using preprandial injectable insulin |
Inclusion Criteria: * Type 2 Diabetes Mellitus * Insulin naive * One or more oral antihyperglycemic medications * HbA1c greater than or equal to 8.0% and less than or equal to 10.5% * Non-smoker Exclusion Criteria: * Taking a TZD dose greater than what is indicated * Have not taken insulin within...
Human Insulin is an investigational small molecule developed by Eli Lilly and Company for the treatment of diabetes mellitus, including both type 1 and type 2 diabetes. It is being studied as an inhaled formulation of insulin, also known as human insulin inhalation powder (HIIP), across a clinical program that has enrolled more than 2,200 patients.
Human Insulin is being developed to treat Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2. Clinical trials have evaluated it in adults with type 1 and type 2 diabetes, with the goal of providing glycemic control through an inhaled route of administration rather than injection.
Human Insulin targets INSR, the insulin receptor, and acts as an agonist at that receptor. By activating the insulin receptor, it is designed to reproduce the metabolic effects of endogenous insulin in patients with diabetes mellitus who require insulin therapy.
Human Insulin is being developed by Eli Lilly and Company, which trades under the ticker LLY. Lilly has sponsored the clinical trial program evaluating the inhaled human insulin formulation, also referred to as human insulin inhalation powder (HIIP), in patients with type 1 and type 2 diabetes.
Human Insulin is in Phase 3 clinical development and is investigational. Five trials have been completed, including Phase 2 and Phase 3 studies, and no trials are currently active. The program has enrolled approximately 2,260 participants across randomized, active-controlled studies.
Completed Human Insulin trials include NCT00490854, a Phase 2 study in type 2 diabetes in Japan; NCT00437112, a Phase 3 comparison with glargine in type 2 diabetes; NCT00356109, a Phase 3 study in type 1 diabetes; and NCT00355849, a Phase 3 study in type 2 diabetes conducted across multiple countries.
Yes. Human Insulin is also known as Human Insulin Inhalation Powder, or human insulin inhalation powder (HIIP). These names refer to the same Eli Lilly and Company product candidate, an inhaled formulation of insulin being studied in diabetes mellitus.