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Afrezza in insulin-naive type 2 diabetes mellitus (Affinity 2)
NCT01451398Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2011
- Primary completion
- Jun 2013
- Countries
- 4
- Sponsor
- MannKind
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 3, randomised, double-blind trial of TI-Inhalation Powder B in type 2 diabetes mellitus (T2DM) (2 arms), sponsored by MannKind. Primary endpoint: Change From Baseline to Week 24 in HbA1c. Started Nov 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Technosphere Insulin
Inhaled Technosphere Insulin added to 2 or more stable OADs
Technosphere Powder
Inhaled Technosphere Powder (placebo) added to 2 or more stable OADs
03
Endpoints
Primary
Change From Baseline to Week 24 in HbA1c
Secondary
Proportion of Responders Achieving HbA1c <= 7.0%
Proportion of Responders Achieving HbA1c <= 6.5%
Fasting Plasma Glucose Change From Baseline to Week 24
Proportion of Subjects Requiring Rescue Therapy
Time to Rescue
Forced Expiratory Volume in 1 Second Change From Baseline to Week 24
Incidence of Total Hypoglycemia
Incidence of Severe Hypoglycemia
04
Results
Primary endpoints met
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