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

Phase 3

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Addition of mealtime Afrezza Inhalation Powder	Afrezza Inhalant Product	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

Primary Outcome Measures

Name	Time	Method
Change in Percentage of HbA1c From Baseline to 3 Months	Baseline to 3 months	Change in percentage of HbA1c from baseline to 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher and 11.5% or lower

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With HbA1c Under 7% at 3 Months	3 months	Percentage of patients with uncontrolled type 2 diabetes with HbA1c that is under 7% at 3 months
Percent of Time With Blood Glucose (BG) Under 70 mg/dL on CGMS	3 months	Percent of time with BG under 70 mg/dL on CGMS at 3 months in participants with uncontrolled type 2 diabetes.