NCT03324776

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Model Clinical Research LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
DRUG	Afrezza Inhalant Product	Mealtime Ultra-Rapid Acting Insulin

Timeline

• Start date: 2017-10-16
• Primary completion: 2020-06-10
• Completion: 2020-06-10
• First posted: 2017-10-30
• Last updated: 2024-06-26
• Results posted: 2024-06-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study