Post by StevieRay on Aug 25, 2013 18:54:16 GMT -5
Preliminary Results:
www.investors.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1847570&highlight=
Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period
www.clinicaltrials.gov/ct2/show/NCT01445951?term=Mannkind+171&rank=1
Primary Outcome Measures: •Effect of treatment as measured by change in glycated hemoglobin (HbA1c): Comparison of baseline HbA1c to end of treatment HbA1c after 24 weeks [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures: •FEV1 changes from Baseline to the final treatment visit compared between TI-Gen2C and TI-MedTone C treatment groups [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
•Comparison of mean change from randomization visit to Week 24 visit in fasting plasma glucose (FPG) levels (central laboratory results) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
•Comparison of mean 7-point glucose from the week before the randomization visit to those measured the week before the Week 24 visit [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
•Change in body weight from Randomization to the end of the treatment period [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
www.investors.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1847570&highlight=
Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period
www.clinicaltrials.gov/ct2/show/NCT01445951?term=Mannkind+171&rank=1
Primary Outcome Measures: •Effect of treatment as measured by change in glycated hemoglobin (HbA1c): Comparison of baseline HbA1c to end of treatment HbA1c after 24 weeks [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures: •FEV1 changes from Baseline to the final treatment visit compared between TI-Gen2C and TI-MedTone C treatment groups [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
•Comparison of mean change from randomization visit to Week 24 visit in fasting plasma glucose (FPG) levels (central laboratory results) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
•Comparison of mean 7-point glucose from the week before the randomization visit to those measured the week before the Week 24 visit [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
•Change in body weight from Randomization to the end of the treatment period [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]