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

• Sponsor: Diabetes and Glandular Disease Clinic (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT04125082
• Collaborator: Mannkind Corporation (Industry), DexCom, Inc. (Industry)
• Enrollment: 29
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12.6
• Patients Per Site Per Month: 2.3

Study Details

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

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: N/A
• 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: Feb 27, 2019
• Anticipated Primary Completion Date: Mar 15, 2020
• Anticipated Study Completion Date: Mar 15, 2020

Arms and Interventions

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

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.

Outcome Measures

Primary Outcome Measures

1. Time In Range [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 [Week 2 to Week 16]

   Incidence of significant hypoglycemic events

Secondary Outcome Measures

1. Hemoglobin A1c [Week 2 to Week 16]

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

2. Quality of Life Questionnaires [Screening to Week 16]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diabetes and Glandular Disease Clinic, P.A.	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• Diabetes and Glandular Disease Clinic
• Mannkind Corporation
• DexCom, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Diabetes and Glandular Disease Clinic
• ClinicalTrials.gov Identifier: NCT04125082
• Other Study ID Numbers: MK-001
• First Posted: Oct 14, 2019
• Last Update Posted: Jan 30, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Diabetes Mellitus, Type 2; Insulin; Insulin, Globin Zinc

Study Results

No Results Posted as of Jan 30, 2020