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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...