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

NCT04125082 | Unknown Phase 4 FDA Drug

• 1 other identifier: MK-001
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes Treated With Insulin

Outcome Measures

Primary Outcomes (2)

• Time In Range

  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

  Incidence of significant hypoglycemic events

  Week 2 to Week 16

Secondary Outcomes (2)

• Hemoglobin A1c

  Week 2 to Week 16

• Quality of Life Questionnaires

  Screening to Week 16

Study Arms (1)

Type 2 Diabetics

OTHER

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

Interventions

Afrezza Inhalant Product DRUG

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.

Type 2 Diabetics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Diabetes and Glandular Disease Clinic, P.A.

San Antonio, Texas, 78229, United States

Location

Study Officials

• Mark Kipnes, M.D.

  Diabetes and Glandular Disease Clinic, P.A.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 14, 2019
• Study Start: February 27, 2019
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)