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.

简要总结

主要结局

次要结局

• 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.