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

January 28, 2020 updated by: Diabetes and Glandular Disease Clinic

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

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

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • San Antonio, Texas, United States, 78229
        • Diabetes and Glandular Disease Clinic, P.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time In Range
Time Frame: 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®).
Week 2 to End of Study
Hypoglycemia
Time Frame: Week 2 to Week 16
Incidence of significant hypoglycemic events
Week 2 to Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c
Time Frame: Week 2 to Week 16
Evaluation of A1c from visit week 2 baseline to final study visit
Week 2 to Week 16
Quality of Life Questionnaires
Time Frame: Screening to Week 16
Evaluation of Diabetes Quality of Life Questionnaires from baseline to final study visit.
Screening to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mark Kipnes, M.D., Diabetes and Glandular Disease Clinic, P.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2019

Primary Completion (Anticipated)

March 15, 2020

Study Completion (Anticipated)

March 15, 2020

Study Registration Dates

First Submitted

October 9, 2019

First Submitted That Met QC Criteria

October 10, 2019

First Posted (Actual)

October 14, 2019

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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