Effect on Glycemic Control of Inhaled Insulin Alone or Added to Dual Oral Therapy After Failure of Dual Oral Therapy.
This study has been completed.
Information provided by:
First received: August 29, 2006
Last updated: February 9, 2007
Last verified: February 2007
To assess the impact on glucose control by inhaled insulin alone or added to two oral anti-diabetic agents in patients with type 2 diabetes who are not well controlled on 2 oral anti-diabetic agents.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 Outcome Measures:
- 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.
|Study Start Date:||June 1999|
|Estimated Study Completion Date:||September 2000|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00370565
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Sponsors and Collaborators
|Study Director:||Pfizer CT.gov Call Center||Pfizer|