Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Exubera (inhaled insulin)
Exubera · 2 trials · 2 indications
Change from Baseline in glycosylated hemoglobin A1c (HbA1c %) at Week 24. Change = mean value at Week 24 minus mean value at Baseline.
| Arm | Type | Description |
|---|---|---|
| Insulin Lispro | ACTIVE_COMPARATOR | Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents. |
| Exubera | EXPERIMENTAL | Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents. |
| Name | Type | Description |
|---|---|---|
| Insulin Lispro | DRUG | Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents. |
| Exubera | DRUG | Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents. |
| Exubera (inhaled insulin) | DRUG | - |
| 8-point glucose diary (to assess pre- and post prandial glucoses) | PROCEDURE | - |
| Meal Tolerance Test | PROCEDURE | - |
| 24-hour continuous glucose monitoring (at select sites) | PROCEDURE | - |
| Pulmonary Function Testing | PROCEDURE | - |
| Hypoglycemic Event Monitoring | PROCEDURE | - |
| Laboratory Assessments | PROCEDURE | - |
| Nutritional Counseling and Diabetes Education | BEHAVIORAL | - |
Inclusion Criteria: * Adults with type 2 diabetes using Lantus® (insulin glargine) as their basal insulin, not at glycemic goal. Exclusion Criteria: * lung disease * current smoking or discontinued smoking within past 6 months
Exubera is an inhaled insulin product developed by Pfizer, Inc. (ticker PFE) for the treatment of diabetes mellitus, including type 2 diabetes. It is a small molecule therapy in the metabolic therapeutic area. It was studied as an alternative route of insulin delivery compared with injected insulin in patients with diabetes.
Exubera is used for the treatment of diabetes mellitus, including type 2 diabetes. Clinical development focused on glycemic control in adults with type 2 diabetes, including a Phase 3 study comparing Exubera with lispro insulin in a Lantus-based regimen. It is an inhaled insulin formulation rather than an injected one.
Exubera is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the clinical trial program for the inhaled insulin product, including the Phase 3 studies conducted in the United States and Puerto Rico.
Exubera was studied in Phase 3 clinical development. The Phase 3 trials in the program have been completed, and the studies enrolled adults 18 years and older with diabetes mellitus, including type 2 diabetes. The program includes completed randomized, active-controlled trials.
Exubera was evaluated in Phase 3 trials including NCT00348374, which compared Exubera with lispro in a Lantus-based regimen for glycemic control in type 2 diabetes, and NCT00246623, a US inhaled insulin dose titration study in type 2 diabetes. Both trials are completed.
Exubera is also known as Exubera (inhaled insulin). It is an inhaled formulation of insulin developed by Pfizer for diabetes mellitus, including type 2 diabetes, and was studied in Phase 3 trials as an alternative to injected insulin for glycemic control.