Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients

AFR-001

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.

2017-10-16

2020-06-10

2020-06-10

Completed

Early phase I

20

Inclusion Criteria: * 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). Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

2024-06-26