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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

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ClinicalTrials.gov Identifier: NCT04125082
Recruitment Status : Recruiting
First Posted : October 14, 2019
Last Update Posted : October 14, 2019
Sponsor:
Collaborators:
Mannkind Corporation
DexCom, Inc.
Information provided by (Responsible Party):
Diabetes and Glandular Disease Clinic

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Treated With Insulin Drug: Afrezza Inhalant Product Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 27, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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.




Primary Outcome Measures :
  1. 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®).

  2. Hypoglycemia [ Time Frame: Week 2 to Week 16 ]
    Incidence of significant hypoglycemic events


Secondary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: Week 2 to Week 16 ]
    Evaluation of A1c from visit week 2 baseline to final study visit

  2. Quality of Life Questionnaires [ Time Frame: Screening to Week 16 ]
    Evaluation of Diabetes Quality of Life Questionnaires from baseline to final study visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04125082


Contacts
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Contact: Terri Ryan 210-614-8612 ext 1630 Terri.Ryan@dgdclinic.com

Locations
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United States, Texas
Diabetes and Glandular Disease Clinic, P.A. Recruiting
San Antonio, Texas, United States, 78229
Contact: Terri Ryan    210-614-8612 ext 1630    Terri.Ryan@dgdclinic.com   
Principal Investigator: Mark Kipnes, M.D.         
Sponsors and Collaborators
Diabetes and Glandular Disease Clinic
Mannkind Corporation
DexCom, Inc.
Investigators
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Principal Investigator: Mark Kipnes, M.D. Diabetes and Glandular Disease Clinic, P.A.

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Responsible Party: Diabetes and Glandular Disease Clinic
ClinicalTrials.gov Identifier: NCT04125082     History of Changes
Other Study ID Numbers: MK-001
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs