Clinical trial NCT03324776
Conditions: Type2 Diabetes
Keywords: inhaled insulin
Sponsor: Model Clinical Research LLC
Start date: 2017-10-16; Completion date: 2020-06-10
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To examine the effects of adding prandial Afrezza inhaled insulin to patients with type 2 diabetes who are not controlled after at least 6 months of other diabetes treatments including oral agents, basal insulin, or GLP-1 use.

Detailed description:
Clinical inertia in intensifying treatment of type 2 diabetes patients occurs in the range of 70% in numerous real world database assessments. The investigator proposes treating patients with Afrezza who have an index hemoglobin A1c (HbA1c) between 7.5% and 11.5% despite being treated with diabetes medications for at least 6 months. The response to Afrezza will be assessed with Continuous Glucose Monitoring Systems (CGMS) studies and initial and follow-up HbA1c's. The goal is to assess how the investigator can rapidly and safely initiate intensification in this patient population, where extensive delays in HbA1c improvement often occur.

Arms: arm 1: Patients will be instructed to follow a Weekly Treat-to-Target BG Testing Regimen and make Afrezza dose changes according to an Afrezza Titration Algorithm
Interventions: intervention 1: Afrezza Inhalant Product
Intervention descriptions: intervention 1: Mealtime Ultra-Rapid Acting Insulin

Protocol documents:
Prot_000.pdf: 
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