|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Open Label, Parallel Assignment |
| Condition: |
Diabetes Mellitus, Type 2 |
| Interventions: |
Drug: Insulin glargine Drug: Inhaled Insulin (Exubera) |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
| Description | |
|---|---|
| Inhaled Human Insulin | Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents. |
| Insulin Glargine | Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents. |
| Inhaled Human Insulin | Insulin Glargine | |
|---|---|---|
| STARTED | 219 | 194 |
| Received Treatment | 212 | 190 |
| COMPLETED | 136 | 152 |
| NOT COMPLETED | 83 | 42 |
| Adverse Event | 7 | 1 |
| Lack of Efficacy | 1 | 3 |
| Lost to Follow-up | 10 | 4 |
| Withdrawal by Subject | 31 | 7 |
| Unknown | 27 | 23 |
| Randomized but did not receive treatment | 7 | 4 |
Baseline Characteristics
| Description | |
|---|---|
| Inhaled Human Insulin | Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents. |
| Insulin Glargine | Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents. |
| Inhaled Human Insulin | Insulin Glargine | Total | |
|---|---|---|---|
|
Number of Participants [units: participants] |
212 | 190 | 402 |
|
Age, Customized [units: participants] |
|||
| 18 to 44 years | 27 | 26 | 53 |
| 45 to 65 years | 151 | 125 | 276 |
| >=65 years | 34 | 39 | 73 |
|
Gender [units: participants] |
|||
| Female | 92 | 84 | 176 |
| Male | 120 | 106 | 226 |
Outcome Measures
| 1. Primary: | Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population |
| 2. Secondary: | Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26 |
| 3. Secondary: | Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26 |
| 4. Secondary: | Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26 |
| 5. Secondary: | Change From Baseline in Fasting Plasma Glucose at Week 26 |
| 6. Secondary: | Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26 |
| 7. Secondary: | Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26 |
| 8. Secondary: | Change From Baseline in Lipids at Week 26 |
| 9. Secondary: | Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26 |
| 10. Secondary: | Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26 |
| 11. Secondary: | Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26 |
| 12. Secondary: | Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26 |
| 13. Secondary: | Number of Subjects With Hypoglycemic Events |
| 14. Secondary: | Number of Total Hypoglycemic Events |
| 15. Secondary: | Number of Total Subject Months of Treatment |
| 16. Secondary: | Crude Hypoglycemic Event Rate |
| 17. Secondary: | Number of Nocturnal Hypoglycemic Events |
| 18. Secondary: | Change From Baseline in Body Weight at Week 26 |
| 19. Secondary: | Change From Baseline in Body Mass Index (BMI) at Week 26 |
| 20. Other Pre-specified: | Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| Due to cancellation of the EXUBERA program, the collected Patient Reported Outcome (PRO) data were not summarized, and no statistical analyses were performed. |
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A2171095 |
| Study First Received: | January 3, 2007 |
| Results First Received: | July 30, 2009 |
| Last Updated: | September 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00418522 History of Changes |
| Health Authority: | United States: Food and Drug Administration |