Effect on Glycemic Control of Inhaled Insulin Alone or Ad... | NCT00370565 | Trialant

Effect on Glycemic Control of Inhaled Insulin Alone or Ad... | NCT00370565 | Trialant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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;

Contacts/Locations Module