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

Completed · Phase 3

Conditions studied: Type2 Diabetes

In brief

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.

Key facts

Study ID

NCT03324776

Run by

Model Clinical Research LLC

People needed

20

Starts

2017-10-16

Expected to finish

2020-06-10

Last updated by the study team

2024-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• MODEL Clinical Research — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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