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

NCT ID: NCT04125082

Last Updated: 2020-01-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-27
• Study Completion Date: 2020-03-15

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

Conditions

Type 2 Diabetes Treated With Insulin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Type 2 Diabetics

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

Group Type: OTHER

Afrezza Inhalant Product

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mannkind Corporation

INDUSTRY

Sponsor Role: collaborator

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

Diabetes and Glandular Disease Clinic

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Kipnes, M.D.

Role: PRINCIPAL_INVESTIGATOR

Diabetes and Glandular Disease Clinic, P.A.

Locations

Diabetes and Glandular Disease Clinic, P.A.

San Antonio, Texas, United States

Countries

United States

Other Identifiers

MK-001

Identifier Type: -

Identifier Source: org_study_id