Type2 DiabetesPhase 3NCT03324776
Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients
A Phase 3 study testing Afrezza Inhalant Product in people with Type2 Diabetes, run by Model Clinical Research LLC at 1 site in United States.
Trial summary
To examine the effects of adding prandial Afrezza inhaled insulin to patients with type 2 diabetes who are not controlled after at least 6 months of other diabetes treatments including oral agents, basal insulin, or GLP-1 use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Afrezza Inhalant Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2017to 10 Jun 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult type 2 diabetes patients age 18 or older
- HbA1c ≥ 7.5% and ≤ 11.5% after at least 6 months treatment with diabetes medication. Treatment may include oral agents, basal insulin or Glucagon-like peptide-1 (GLP-1) in any combination.
- Patient and provider agree not to add additional diabetes medications during the 14 weeks of the study (unless rescue treatment is indicated).
Who cannot join
- History of asthma, chronic obstructive pulmonary disease (COPD) or smoking within 6 months
- Forced Expiratory Volume in one second (FEV1) under 70% predicted
- Pregnancy
- Active malignancies and/or life expectancy of < 12 months
- Major surgery planned during study period
- Currently using rapid acting insulins - Novolog, Humalog, Apidra
Show all 11Show fewer
- Prior use of Afrezza in the last 3 months
- Unwilling to test blood glucose before or after each meal
- Exposure to systemic glucocorticoids within 6 weeks of screening
- Severe hypoglycemia in last 6 months or hypoglycemia unawareness
- Any medical condition which, in the opinion of the investigator, would interfere with ability to understand or respond to the administration of inhaled insulin
Trial locations and contacts
1 site in 1 country.
About this study
To examine the effects of adding prandial Afrezza inhaled insulin to patients with type 2 diabetes who are not controlled after at least 6 months of other diabetes treatments including oral agents, basal insulin, or GLP-1 use.
Read the detailed description
Clinical inertia in intensifying treatment of type 2 diabetes patients occurs in the range of 70% in numerous real world database assessments. The investigator proposes treating patients with Afrezza who have an index hemoglobin A1c (HbA1c) between 7.5% and 11.5% despite being treated with diabetes medications for at least 6 months. The response to Afrezza will be assessed with Continuous Glucose Monitoring Systems (CGMS) studies and initial and follow-up HbA1c's. The goal is to assess how the investigator can rapidly and safely initiate intensification in this patient population, where extensive delays in HbA1c improvement often occur.
- Conditions
- Type2 Diabetes
- Being tested
- Afrezza Inhalant Product
- Keywords
- inhaled insulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Afrezza Inhalant ProductDrug
Also called Afrezza Inhaled Insulin
Mealtime Ultra-Rapid Acting Insulin
| Study group | Role | What they receive |
|---|---|---|
| Addition of mealtime Afrezza Inhalation Powder | Other | Patients will be instructed to follow a Weekly Treat-to-Target BG Testing Regimen and make Afrezza dose changes according to an Afrezza Titration Algorithm Receives: Drug: Afrezza Inhalant Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percentage of HbA1c From Baseline to 3 Months
Change in percentage of HbA1c from baseline to 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher and 11.5% or lower
Measured: Baseline to 3 months
Secondary outcomes (2)
Percentage of Patients With HbA1c Under 7% at 3 Months
Percentage of patients with uncontrolled type 2 diabetes with HbA1c that is under 7% at 3 months
Measured: 3 months
Percent of Time With Blood Glucose (BG) Under 70 mg/dL on CGMS
Percent of time with BG under 70 mg/dL on CGMS at 3 months in participants with uncontrolled type 2 diabetes.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start16 Oct 2017
- Primary completion10 Jun 2020
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type2 DiabetesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Model Clinical Research LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Mannkind Corporation
- Responsible party
- Principal investigator, Philip Levin, Model Clinical Research LLC
- Investigators
- Philip Levin, MD, Principal investigator, Senior Director of MODEL Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324776
- Sponsor's protocol ID
- AFR-001
- Status last verified
- Jun 2024
- First submitted
- 25 Oct 2017
- Last updated
- 26 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT03324776
- Acronym / sponsor ID
- AFR-001
- Conditions
- Type2 Diabetes
- Keywords
- inhaled insulin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Model Clinical Research LLCUniversity, hospital or other
- Collaborators
- Mannkind Corporation
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 30 Oct 2017 (actual)
- Results
- Posted 26 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the effects of adding prandial Afrezza inhaled insulin to patients with type 2 diabetes who are not controlled after at least 6 months of other diabetes treatments including oral agents, basal insulin, or GLP-1 use.
Detailed description
Clinical inertia in intensifying treatment of type 2 diabetes patients occurs in the range of 70% in numerous real world database assessments. The investigator proposes treating patients with Afrezza who have an index hemoglobin A1c (HbA1c) between 7.5% and 11.5% despite being treated with diabetes medications for at least 6 months. The response to Afrezza will be assessed with Continuous Glucose Monitoring Systems (CGMS) studies and initial and follow-up HbA1c's. The goal is to assess how the investigator can rapidly and safely initiate intensification in this patient population, where extensive delays in HbA1c improvement often occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Addition of mealtime Afrezza Inhalation Powder | Other | Drug: Afrezza Inhalant ProductPatients will be instructed to follow a Weekly Treat-to-Target BG Testing Regimen and make Afrezza dose changes according to an Afrezza Titration Algorithm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult type 2 diabetes patients age 18 or older
- HbA1c ≥ 7.5% and ≤ 11.5% after at least 6 months treatment with diabetes medication. Treatment may include oral agents, basal insulin or Glucagon-like peptide-1 (GLP-1) in any combination.
- Patient and provider agree not to add additional diabetes medications during the 14 weeks of the study (unless rescue treatment is indicated).
Key exclusion criteria (11 listed)
- History of asthma, chronic obstructive pulmonary disease (COPD) or smoking within 6 months
- Forced Expiratory Volume in one second (FEV1) under 70% predicted
- Pregnancy
- Active malignancies and/or life expectancy of < 12 months
- Major surgery planned during study period
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 ProductAlso: Afrezza Inhaled InsulinMealtime Ultra-Rapid Acting Insulin | Drug | Addition of mealtime Afrezza Inhalation Powder |
Primary outcome
Change in Percentage of HbA1c From Baseline to 3 Months
Time frame: Baseline to 3 months
Change in percentage of HbA1c from baseline to 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher and 11.5% or lower
2 secondary outcomes
Percentage of Patients With HbA1c Under 7% at 3 Months
Time frame: 3 months
Percent of Time With Blood Glucose (BG) Under 70 mg/dL on CGMS
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Philip Levin, MD principal investigator
Senior Director of MODEL Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Afrezza Inhalant Product in people with Type2 Diabetes, run by Model Clinical Research LLC 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 26 Jun 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Percentage of HbA1c From Baseline to 3 Months (time frame: Baseline to 3 months). 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 26 Jun 2024.