Type 2 Diabetes Treated With Insulin
Conditions
Brief 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
Interventions
Participants will be titrated from usual pre-meal insulin plus basal to Afrezza® inhaled insulin plus basal, and will continue on treatment for 14 weeks.
Sponsors
Mannkind Corporation
DexCom, Inc.
Diabetes and Glandular Disease Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia | Week 2 to Week 16 | Incidence of significant hypoglycemic events |
| Time In Range | Week 2 to End of Study | Evaluation of percentage of time spent in goal range, above (hyperglycemic range) and below (hypoglycemic range) via CGM system from visit week 2 baseline to final study visit with inhaled insulin (Afrezza®). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | Week 2 to Week 16 | Evaluation of A1c from visit week 2 baseline to final study visit |
| Quality of Life Questionnaires | Screening to Week 16 | Evaluation of Diabetes Quality of Life Questionnaires from baseline to final study visit. |
Countries
United States
Outcome results
None listed