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

Primary Purpose

Type 2 Diabetes Treated With Insulin

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Afrezza Inhalant Product

About this trial

This is an interventional treatment trial for Type 2 Diabetes Treated With Insulin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 years or older
Diagnosed with Type 2 diabetes mellitus treated with multiple daily injections
Screening A1c 7.5 % - 11.5% inclusive
Willing and able to wear CGM system during the study
Willing to use only inhaled insulin (Afrezza®) at meals and for correction
Able to understand, speak, read and write English
Female of child-bearing potential willing to use contraceptive measures to prevent pregnancy

Exclusion Criteria:

Diagnosed with COPD
Is an active smoker , or has smoked in the past 6 months
Diagnosed with asthma
Pregnancy, breast-feeding or planning to become pregnant during study period
Have a disease or condition that, in the opinion of the Investigator, could affect subject safety or interfere with their participation in the study
Use of oral or injected corticosteroid within 6 weeks of study enrollment
Enrollment in another investigational trial at the time of screening

Sites / Locations

Diabetes and Glandular Disease Clinic, P.A.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Type 2 Diabetics

Arm 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

Outcomes

Primary Outcome Measures

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®).

Hypoglycemia

Incidence of significant hypoglycemic events

Secondary Outcome Measures

Hemoglobin A1c

Evaluation of A1c from visit week 2 baseline to final study visit

Quality of Life Questionnaires

Evaluation of Diabetes Quality of Life Questionnaires from baseline to final study visit.

Full Information

NCT ID

NCT04125082

First Posted

October 9, 2019

Last Updated

January 28, 2020

Sponsor

Diabetes and Glandular Disease Clinic

Collaborators

Mannkind Corporation, DexCom, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04125082

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

February 27, 2019 (Actual)

Primary Completion Date

March 15, 2020 (Anticipated)

Study Completion Date

March 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Diabetes and Glandular Disease Clinic

Collaborators

Mannkind Corporation, DexCom, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Treated With Insulin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Type 2 Diabetics

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

Afrezza Inhalant Product

Intervention 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.

Primary Outcome Measure Information:

Title

Time In Range

Description

Time Frame

Week 2 to End of Study

Title

Hypoglycemia

Description

Incidence of significant hypoglycemic events

Time Frame

Week 2 to Week 16

Secondary Outcome Measure Information:

Title

Hemoglobin A1c

Description

Evaluation of A1c from visit week 2 baseline to final study visit

Time Frame

Week 2 to Week 16

Title

Quality of Life Questionnaires

Description

Evaluation of Diabetes Quality of Life Questionnaires from baseline to final study visit.

Time Frame

Screening to Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 years or older Diagnosed with Type 2 diabetes mellitus treated with multiple daily injections Screening A1c 7.5 % - 11.5% inclusive Willing and able to wear CGM system during the study Willing to use only inhaled insulin (Afrezza®) at meals and for correction Able to understand, speak, read and write English Female of child-bearing potential willing to use contraceptive measures to prevent pregnancy Exclusion Criteria: Diagnosed with COPD Is an active smoker , or has smoked in the past 6 months Diagnosed with asthma Pregnancy, breast-feeding or planning to become pregnant during study period Have a disease or condition that, in the opinion of the Investigator, could affect subject safety or interfere with their participation in the study Use of oral or injected corticosteroid within 6 weeks of study enrollment Enrollment in another investigational trial at the time of screening

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Kipnes, M.D.

Organizational Affiliation

Diabetes and Glandular Disease Clinic, P.A.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Diabetes and Glandular Disease Clinic, P.A.

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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