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
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Treated With Insulin||Drug: Afrezza Inhalant Product||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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®).
- Hypoglycemia [ Time Frame: Week 2 to Week 16 ]Incidence of significant hypoglycemic events
- Hemoglobin A1c [ Time Frame: Week 2 to Week 16 ]Evaluation of A1c from visit week 2 baseline to final study visit
- Quality of Life Questionnaires [ Time Frame: Screening to Week 16 ]Evaluation of Diabetes Quality of Life Questionnaires from baseline to final study visit.
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
|Contact: Terri Ryan||210-614-8612 ext 1630||Terri.Ryan@dgdclinic.com|
|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.|
|Principal Investigator:||Mark Kipnes, M.D.||Diabetes and Glandular Disease Clinic, P.A.|