- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04125082
A Study to Evaluate Time in Range in Type 2 Diabetics Using Afrezza® Plus Basal Insulin Compared to Multiple Daily Injections
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Texas
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San Antonio, Texas, United States, 78229
- Diabetes and Glandular Disease Clinic, P.A.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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.
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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
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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®).
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Week 2 to End of Study
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Hypoglycemia
Time Frame: Week 2 to Week 16
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Incidence of significant hypoglycemic events
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Week 2 to Week 16
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin A1c
Time Frame: Week 2 to Week 16
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Evaluation of A1c from visit week 2 baseline to final study visit
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Week 2 to Week 16
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Quality of Life Questionnaires
Time Frame: Screening to Week 16
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Evaluation of Diabetes Quality of Life Questionnaires from baseline to final study visit.
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Screening to Week 16
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Collaborators and Investigators
Investigators
- Principal Investigator: Mark Kipnes, M.D., Diabetes and Glandular Disease Clinic, P.A.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MK-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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