Trial | NCT03324776  Report issue

Official Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    28
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.
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 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 HbA1cs. 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.
Study Started
Oct 16
2017
Primary Completion
Jun 10
2020
Study Completion
Jun 10
2020
Last Update
Sep 16
2020

Drug Afrezza Inhalant Product

Mealtime Ultra-Rapid Acting Insulin

  • Other names: Afrezza Inhaled Insulin

Afrezza Inhalant Product Other

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

Criteria 

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 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, COPD or smoking within 6 months
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 PI, would interfere with ability to understand or respond to the administration of inhaled insulin
No Results Posted