A Study to Evaluate Time in Range in Type 2 Diabetics Using Afrezza® Plus Basal Insulin Compared to Multiple Daily Injections

• Status: Active, not recruiting
• Trial end date: 2020-03-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to collect CGM, A1c and Quality of Life data in subjects with Type 2 diabetes before and after transitioning from Multiple Daily Injections to Basal plus Bolus with Afrezza® inhaled insulin. The primary objective is to evaluate the percentage of time spent in goal range without significant hypoglycemia. Additional objectives include evaluation of A1c and Quality of Life data. The expected outcomes are improvement of time in range, no change or improvement in A1c and favorable Quality of Life data

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Diabetes and Glandular Disease Clinic
• Collaborators: DexCom, Inc.; Mannkind Corporation
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

1. Age 18 years or older

2. Diagnosed with Type 2 diabetes mellitus treated with multiple daily injections

3. Screening A1c 7.5 % - 11.5% inclusive

4. Willing and able to wear CGM system during the study

5. Willing to use only inhaled insulin (Afrezza®) at meals and for correction

6. Able to understand, speak, read and write English

7. Female of child-bearing potential willing to use contraceptive measures to prevent pregnancy

Exclusion Criteria:

1. Diagnosed with COPD

2. Is an active smoker , or has smoked in the past 6 months

3. Diagnosed with asthma

4. Pregnancy, breast-feeding or planning to become pregnant during study period

5. Have a disease or condition that, in the opinion of the Investigator, could affect subject safety or interfere with their participation in the study

6. Use of oral or injected corticosteroid within 6 weeks of study enrollment

7. Enrollment in another investigational trial at the time of screening