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

Type 2 Diabetes Treated With Insulin Clinical Trial

Official title:

A Single-Site, Investigator-Initiated Study to Evaluate Time in Range in Subjects With Type 2 Diabetes Mellitus Using Mealtime Inhaled Insulin (Afrezza®) Plus Basal Insulin Compared to Multiple Daily Injections

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04125082
• Other study ID #: MK-001
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: February 27, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: January 2020
• Source: Diabetes and Glandular Disease Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 29
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Treated With Insulin

Intervention

Drug:
• Afrezza Inhalant Product
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.

Locations

Country	Name	City	State
United States	Diabetes and Glandular Disease Clinic, P.A.	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Diabetes and Glandular Disease Clinic	DexCom, Inc., Mannkind Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time In Range	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®).	Week 2 to End of Study
Primary	Hypoglycemia	Incidence of significant hypoglycemic events	Week 2 to Week 16
Secondary	Hemoglobin A1c	Evaluation of A1c from visit week 2 baseline to final study visit	Week 2 to Week 16
Secondary	Quality of Life Questionnaires	Evaluation of Diabetes Quality of Life Questionnaires from baseline to final study visit.	Screening to Week 16