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

Model Clinical Research

Status and phase: Completed; Phase 3

Conditions: Type2 Diabetes

Treatments: Drug: Afrezza Inhalant Product

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03324776

AFR-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Addition of mealtime Afrezza Inhalation Powder

Other group

Description:

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

Treatment:

Drug: Afrezza Inhalant Product