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

• Status: Completed
• Trial end date: 2020-06-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Model Clinical Research LLC
• Collaborator: Mannkind Corporation
• Treatments: Insulin; Insulin, Globin Zinc; Insulin, Short-Acting

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