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

Diabetes & Glandular Disease Clinic (DGD)

Status and phase: Unknown; Phase 4

Conditions: Type 2 Diabetes Treated With Insulin

Treatments: Drug: Afrezza Inhalant Product

Study type: Interventional

Funder types: Industry

Identifiers

NCT04125082

MK-001

Details and patient eligibility

About

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

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Type 2 Diabetics

Other group

Description:

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. Participants will attend study visits at Day 0, Weeks 1, 2, 3, 4, 8, 12 and 16, where insulin titration may be performed based on CGM readings. Participants will receive instruction in carbohydrate counting and corrective insulin dose adjustments. Participants will wear CMG throughout the study. At final study visit, CGM system will be collected. A1c, FEV1 and Quality of Life Questionnaires will be collected. Pregnancy test will be collected for all females of child-bearing potential. Participants will be transitioned back to Multiple Daily Injections plus basal or may choose to continue on commercial Afrezza® inhaled insulin plus basal

Treatment:

Drug: Afrezza Inhalant Product