Type 2 Diabetes Treated With InsulinPhase 4NCT04125082
A Study to Evaluate Time in Range in Type 2 Diabetics Using Afrezza® Plus Basal Insulin Compared to Multiple Daily Injections
A Phase 4 study testing Afrezza Inhalant Product in people with Type 2 Diabetes Treated With Insulin, run by Diabetes and Glandular Disease Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Treated With Insulin
- What is being tested?
- Afrezza Inhalant Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2019to 15 Mar 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Diabetes and Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229
About this study
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
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
- Being tested
- Afrezza Inhalant Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Afrezza Inhalant ProductDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Afrezza Inhalant Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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®).
Measured: Week 2 to End of Study
Hypoglycemia
Incidence of significant hypoglycemic events
Measured: Week 2 to Week 16
Secondary outcomes (2)
Hemoglobin A1c
Evaluation of A1c from visit week 2 baseline to final study visit
Measured: Week 2 to Week 16
Quality of Life Questionnaires
Evaluation of Diabetes Quality of Life Questionnaires from baseline to final study visit.
Measured: Screening to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start27 Feb 2019
- Primary completion15 Mar 2020 (estimated)
- Study completion15 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Treated With InsulinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabetes and Glandular Disease Clinic
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mannkind Corporation, DexCom, Inc.
- Responsible party
- Sponsor
- Investigators
- Mark Kipnes, M.D., Principal investigator, Diabetes and Glandular Disease Clinic, P.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125082
- Sponsor's protocol ID
- MK-001
- Status last verified
- Jan 2020
- First submitted
- 9 Oct 2019
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04125082
- Acronym / sponsor ID
- MK-001
- Conditions
- Type 2 Diabetes Treated With Insulin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Diabetes and Glandular Disease ClinicIndustry (pharma, biotech, devices)
- Collaborators
- Mannkind Corporation, DexCom, Inc.
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 15 Mar 2020 (estimated)
- Study completion
- 15 Mar 2020 (estimated)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetics | Other | Drug: Afrezza Inhalant ProductParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Afrezza Inhalant ProductParticipants will be titrated from usual pre-meal insulin plus basal to Afrezza® inhaled insulin plus basal, and will continue on treatment for 14 weeks. | Drug | Type 2 Diabetics |
Primary outcome
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
2 secondary outcomes
Hemoglobin A1c
Time frame: Week 2 to Week 16
Quality of Life Questionnaires
Time frame: Screening to Week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Kipnes, M.D. principal investigator
Diabetes and Glandular Disease Clinic, P.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Afrezza Inhalant Product in people with Type 2 Diabetes Treated With Insulin, run by Diabetes and Glandular Disease Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time In Range (time frame: Week 2 to End of Study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.