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

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03324776
• Other study ID #: AFR-001
• Status: Completed
• Phase: Phase 3
• Start date: October 16, 2017
• Est. completion date: June 10, 2020

Study information

• Verified date: September 2020
• Source: Model Clinical Research LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 10, 2020
• Est. primary completion date: June 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Drug:
• Afrezza Inhalant Product
Mealtime Ultra-Rapid Acting Insulin

Locations

Country	Name	City	State
United States	MODEL Clinical Research	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Model Clinical Research LLC	Mannkind Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change from baseline HbA1c	Demonstrate that the addition of mealtime Afrezza can significantly lower HbA1c within 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher, despite at least 6 months of prior therapy with diabetes medications.	3 months
Secondary	Percentage of patients having HbA1c under 7%	Demonstrate that the addition of mealtime Afrezza can significantly lower HbA1c within 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher, despite at least 6 months of prior therapy with diabetes medications.	3 months
Secondary	Percent of time that Blood glucose (BG) is under 70 mg/dL on CGMS	Demonstrate that the addition of mealtime Afrezza can lower blood glucose in uncontrolled type 2 diabetes patients.	3 months