Effect on Glycemic Control of Inhaled Insulin Alone or Added to Dual Oral Therapy After Failure of Dual Oral Therapy.
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|ClinicalTrials.gov Identifier: NCT00370565|
Recruitment Status : Completed
First Posted : August 31, 2006
Last Update Posted : February 13, 2007
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Inhaled Human Insulin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||345 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy And Safety Of Exubera (Inhaled Insulin) Therapy In Subjects With Type 2 Diabetes Mellitus Not Well Controlled With Combination Oral Agents: A Three-Month, Outpatient, Parallel Comparative Trial.|
|Study Start Date :||June 1999|
|Estimated Study Completion Date :||September 2000|
- The primary efficacy endpoint is the change from baseline HbA1c measured at 12 weeks after randomization.
- HbA1c is measured at Weeks -4, -1, 0, 6, and 12 of comparative treatment. The baseline value is the mean of the Week -1 and Week 0 values.
- Secondary: Efficacy: change in fasting plasma glucose and meal glucose response (2-h postprandial increment in plasma glucose)Fasting plasma glucose measured at Weeks -4, -1, 0, and 12 (the Weeks -1 and 12 measurements will be part of the meal studies)
- Meal glucose response measured at Week -1 and at Week 12;
- These results for efficacy are measured in the lab using plasma samples collected during clinic visits,
- not the subject’s home glucose monitoring results.
- Comparison of 24-hour home glucose profiles.
- Proportion of subjects with acceptable or good glycemic control (e.g., HbA1c < 8.0% or <7.0%) at the end of treatment, incidence and severity of hypoglycemic episodes, discontinuation rate, change in fasting lipid profile, and change in body weight.
- A patient satisfaction and preference questionnaire will be administered at screening, at baseline, during active therapy, and at the end of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370565
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|