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

M

Model Clinical Research LLC

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 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.

Enrollment

28 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 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

28 participants in 1 patient group

Afrezza Inhalant Product
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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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