Does anyone know what happened to the study below? It shows "active not recruiting" but expected end date was over a year ago with no results posted. This is not normal...right?
clinicaltrials.gov/ct2/show/study/NCT04125082ClinicalTrials.gov
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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
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04125082
Recruitment Status : Active, not recruiting
First Posted : October 14, 2019
Last Update Posted : January 30, 2020
Sponsor:
Diabetes and Glandular Disease Clinic
Collaborators:
Mannkind Corporation
DexCom, Inc.
Information provided by (Responsible Party):
Diabetes and Glandular Disease Clinic
Study DetailsTabular ViewNo Results PostedDisclaimerHow to Read a Study Record
Study Description
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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
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Study Type : Interventional (Clinical Trial)
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 : February 27, 2019
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : March 15, 2020
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics: Type 2 diabetes
Drug Information available for: Insulin Insulin human
U.S. FDA Resources
Arms and Interventions
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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.
Outcome Measures
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Primary Outcome Measures :
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
Secondary Outcome Measures :
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.
Eligibility Criteria
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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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
Contacts and Locations
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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
Locations
United States, Texas
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.
More Information
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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: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
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
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs
In fact I very rarely post on this board anymore, even though I have been here since the agorcom days. 
