Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Model Clinical Research LLC
With
Mannkind Corporation
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult type 2 diabetes patients age 18 or older
HbA1c ≥ 7.5% and ≤ 11.5% after at least 6 months treatment with diabetes medication. Treatment may include oral agents, basal insulin or Glucagon-like peptide-1 (GLP-1) in any combination.
Patient and provider agree not to add additional diabetes medications during the 14 weeks of the study (unless rescue treatment is indicated).
You may not be if
History of asthma, chronic obstructive pulmonary disease (COPD) or smoking within 6 months
Forced Expiratory Volume in one second (FEV1) under 70% predicted
Pregnancy
Active malignancies and/or life expectancy of \< 12 months
Major surgery planned during study period
Currently using rapid acting insulins - Novolog, Humalog, Apidra
Prior use of Afrezza in the last 3 months
Unwilling to test blood glucose before or after each meal
Exposure to systemic glucocorticoids within 6 weeks of screening
Severe hypoglycemia in last 6 months or hypoglycemia unawareness
Any medical condition which, in the opinion of the investigator, would interfere with ability to understand or respond to the administration of inhaled insulin
