Post by StevieRay on Aug 25, 2013 18:57:38 GMT -5
Preliminary Results:
www.investors.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1847440&highlight=
Comparison of Technosphere Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus
www.clinicaltrials.gov/ct2/show/NCT01451398?term=Mannkind+175&rank=1
Primary Outcome Measures: •Efficacy as measured by change in glycated hemoglobin (HbA1c) [ Time Frame: Measured from Week 0 (baseline) to Week 24 (end of treatment) ] [ Designated as safety issue: No ]
Secondary Outcome Measures: •Efficacy as measured in proportion of subjects achieving HbA1c < or = to 7.0% [ Time Frame: Measured from Week 0 (baseline) to Week 24 (end of treatment) ] [ Designated as safety issue: No ]
•Efficacy as measured in proportion of subjects achieving HbA1c < or = to 6.5% [ Time Frame: Measured from Week 0 (baseline) to Week 24 (end of treatment) ] [ Designated as safety issue: No ]
•Efficacy as measured by mean change in fasting plasma glucose (FPG) [ Time Frame: Measured from Week 0 (baseline) to Week 24 (end of treatment) ] [ Designated as safety issue: No ]
•Efficacy as measured in proportion of subjects requiring rescue therapy [ Time Frame: Measured from Week 0 (baseline) to time of rescue ] [ Designated as safety issue: No ]
•Measure the incident and rate of hypoglycemia, cough and other adverse events (AEs) [ Time Frame: Measured from Week 0 (baseline) to Week 24 (end of treatment) ] [ Designated as safety issue: Yes ]
•Measure the changes in anti-insulin immunoglobulin G titers [ Time Frame: Measured from Week 0 (baseline) to Week 24 (end of treatment) ] [ Designated as safety issue: Yes ]
•Changes in lung function [ Time Frame: Measured from Week 0 (baseline) to Week 28 (end of treatment - 24 weeks and 4 week follow up) ] [ Designated as safety issue: Yes ]
•Measure the changes in vital signs, ECGs, clinical laboratory tests, lung function parameters (FEV1, FVC and FEV1/FVC ratio) and physical examination findings [ Time Frame: Measured from Week 0 (baseline) to Week 24 (end of treatment) ] [ Designated as safety issue: Yes ]
•Time to rescue [ Time Frame: Time from Week 0 (baseline) to initiation of rescue therapy (up to a maximum of 24 weeks/end of treatment) for subjects not responding to treatment ] [ Designated as safety issue: No ]
www.investors.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1847440&highlight=
Comparison of Technosphere Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus
www.clinicaltrials.gov/ct2/show/NCT01451398?term=Mannkind+175&rank=1
Primary Outcome Measures: •Efficacy as measured by change in glycated hemoglobin (HbA1c) [ Time Frame: Measured from Week 0 (baseline) to Week 24 (end of treatment) ] [ Designated as safety issue: No ]
Secondary Outcome Measures: •Efficacy as measured in proportion of subjects achieving HbA1c < or = to 7.0% [ Time Frame: Measured from Week 0 (baseline) to Week 24 (end of treatment) ] [ Designated as safety issue: No ]
•Efficacy as measured in proportion of subjects achieving HbA1c < or = to 6.5% [ Time Frame: Measured from Week 0 (baseline) to Week 24 (end of treatment) ] [ Designated as safety issue: No ]
•Efficacy as measured by mean change in fasting plasma glucose (FPG) [ Time Frame: Measured from Week 0 (baseline) to Week 24 (end of treatment) ] [ Designated as safety issue: No ]
•Efficacy as measured in proportion of subjects requiring rescue therapy [ Time Frame: Measured from Week 0 (baseline) to time of rescue ] [ Designated as safety issue: No ]
•Measure the incident and rate of hypoglycemia, cough and other adverse events (AEs) [ Time Frame: Measured from Week 0 (baseline) to Week 24 (end of treatment) ] [ Designated as safety issue: Yes ]
•Measure the changes in anti-insulin immunoglobulin G titers [ Time Frame: Measured from Week 0 (baseline) to Week 24 (end of treatment) ] [ Designated as safety issue: Yes ]
•Changes in lung function [ Time Frame: Measured from Week 0 (baseline) to Week 28 (end of treatment - 24 weeks and 4 week follow up) ] [ Designated as safety issue: Yes ]
•Measure the changes in vital signs, ECGs, clinical laboratory tests, lung function parameters (FEV1, FVC and FEV1/FVC ratio) and physical examination findings [ Time Frame: Measured from Week 0 (baseline) to Week 24 (end of treatment) ] [ Designated as safety issue: Yes ]
•Time to rescue [ Time Frame: Time from Week 0 (baseline) to initiation of rescue therapy (up to a maximum of 24 weeks/end of treatment) for subjects not responding to treatment ] [ Designated as safety issue: No ]