Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 investigational inhaled insulin product being developed for the treatment of diabetes mellitus, including type 2 diabetes. It is intended to help control blood sugar levels in adult patients. The drug is administered via inhalation, offering an alternative to injectable insulin for managing the condition.
Exubera is being developed by Pfizer, Inc., a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the safety and efficacy of Exubera in patients with diabetes mellitus and type 2 diabetes.
Exubera is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trials are designed to assess its efficacy and safety in treating diabetes mellitus and type 2 diabetes, with completed studies involving adult participants.
Exubera has been studied in two completed Phase 3 clinical trials. NCT00246623, titled "US Inhaled Insulin Dose Titration Study," enrolled 120 participants with type 2 diabetes in the United States. NCT00348374, titled "Exubera vs Lispro in a Lantus-based Regimen for Improved Glycemic Control in Type 2 Diabetes," enrolled 191 participants with diabetes mellitus in the United States and Puerto Rico.
Exubera is a small molecule that delivers insulin through inhalation. It is designed to mimic the body's natural insulin response by providing rapid-acting insulin to control postprandial glucose levels. The inhaled formulation allows insulin to be absorbed through the lungs, offering a non-invasive method of administration for diabetes management.
Exubera is a specific inhaled insulin product developed by Pfizer. It is not the same as other inhaled insulins, as each product has its own formulation and delivery system. Exubera's clinical trials focus on its unique dose titration and efficacy compared to other insulin regimens in type 2 diabetes.