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Diabetes Mellitus, Type 1Phase 4STATNCT03143816

Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study

A Phase 4 study testing Technosphere insulin in people with Diabetes Mellitus, Type 1, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an investigator-initiated, prospective, randomized, multicenter, parallel, open-label, pilot clinical trial evaluating the efficacy of TI for PPBG, PPGE, and time-in-range on CGM download in patients with T1D. TI is an inhaled ultra-rapid-acting insulin, approved by the FDA for use in patients with diabetes. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Technosphere insulin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
30 Sep 2017to 31 Jan 2018
Phase
Phase 4
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 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Signed informed consent before any study-related activities,
  • Male or female aged 18-70 years,
  • Type 1 diabetes mellitus (T1D) duration more than six months
  • Treatment with multiple daily injections (MDI) for at least three months before screening visit; stable insulin dose for the last one month,
  • No use of any oral anti-diabetics, any other form of insulin other than mentioned in the protocol, or any other type of injections such as glucagon-like-peptide-1 (GLP-1) analogs, pramlintide or insulin/GLP-1 analog combinations,
  • A1c between 6.5 to 10%,
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  • Willingness to routinely collect at least two blood glucose measurements per day needed to calibrate the CGM. Beyond the calibrations, patients may use CGM for necessary action without having to confirm with fingersticks self-monitoring blood glucose (SMBG), as approved by the Food and Drug Administration (FDA),
  • BMI ≤35 kg/m2,
  • Ability and willingness to adhere to the protocol including clinical and phone visits and 4-week-long CGM wear,
  • Using insulin glargine or insulin degludec as basal insulin,
  • Able to use and understand CGM data,
  • Willing to complete phone and clinic visits,
  • Patients who eat three main meals in a day (breakfast, lunch, and dinner),
  • Patients who use insulin-carb ratio for bolus,
  • Ability to speak, read, and write English, and
  • Patients prandial insulin need must be <18 units per meal

Who cannot join

  • Use of any other diabetic medication other than allowed in the protocol,
  • Pregnant or intention to become pregnant during the study, or not using adequate birth control methods,
  • Severe unexplained hypoglycemia requiring emergency treatment in the previous three months,
  • Use of systemic or inhaled corticosteroids,
  • History of hemoglobinopathies,
  • Diagnosis of anemia,
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  • Post-renal transplantation, currently undergoing dialysis, creatinine >2.0 mg/dl or a calculated creatinine clearance of <50 mL/min,
  • Advanced or unstable retinopathy needing laser procedure or vitrectomy,
  • History of pancreatitis,
  • Extensive skin changes/diseases that inhibit wearing a sensor on normal skin,
  • Known allergy to adhesives,
  • Known allergy to study medication,
  • Participation in another investigational study protocol within 30 days before enrollment,
  • Known chronic obstructive pulmonary disease, pulmonary hypertension, asthma, pulmonary fibrosis, or any chronic pulmonary infection, or any systemic disease that primarily affects the lungs. History of any pulmonary nodule will be excluded to participate in the study,
  • Active smokers,
  • Marijuana users,
  • Insulin pump users,
  • Using insulin detemir or NPH as basal insulin, and
  • Any other condition, as determined by the investigator, which could make the subject unsuitable for the trial, impairs the subject's suitability for the trial, or impairs the validity of the informed consent -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Barbara Davis Center

    Aurora, Colorado, 80045

Other trials in United States

About this study

This is an investigator-initiated, prospective, randomized, multicenter, parallel, open-label, pilot clinical trial evaluating the efficacy of TI for PPBG, PPGE, and time-in-range on CGM download in patients with T1D. TI is an inhaled ultra-rapid-acting insulin, approved by the FDA for use in patients with diabetes. This is a pilot, real-life study where patients will continue their routine diabetes care and use post-meal correction dosages as deemed necessary for normalizing PPBG as per the protocol.

This multi-center study will enroll 60 patients with T1D, A1c values between 6.5 to 10%. The patients will be randomized in 1:1 fashion to either TI or NL. Patients who are randomized into the NL arm will continue using their usual prandial insulin dose before meals. Patients who are randomized into the TI arm will be instructed to dose before the meals and take necessary corrections at 1- and 2-hours after meals to optimize PPBG (Table 1B). There will be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone visits). There will be a 4-week treatment comparison between TI and NL and 1-week of post-study follow up. (Phone visit; Figure-1). Standard lab tests (A1c, complete metabolic panel {CMP}, complete blood count {CBC}) will be performed at the screening visit.

All patients will use real-time CGM (Dexcom G5®, San Diego, CA), which will be provided at the randomization visit for their day-to-day diabetes care. CGM data will be downloaded at every clinic visit on a secured computer. The data will be analyzed after the study for different primary and secondary end points. All patients will be allowed to keep the CGM after the study is over for their day-to-day diabetes care.

Being tested
Technosphere insulin
Keywords
diabetes, time in range, inhaled insulin, continuous glucose monitoring, type 1 diabetes, hypoglycemia, post prandial hypergylcemia
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Technosphere insulinDrug

    This multi-center study will enroll 60 patients with T1D, A1c values between 6.5 to 10%. The patients will be randomized in 1:1 fashion to either TI or NL. Patients who are randomized into the NL arm will continue using their usual prandial insulin dose before meals. Patients who are randomized into the TI arm will be instructed to dose before the meals and take necessary corrections at 1- and 2-hours after meals to optimize PPBG (Table 1B). There will be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone visits). There will be a 4-week treatment comparison between TI and NL and 1-week of post-study follow up. (Phone visit; Figure-1). Standard lab tests (A1c, complete metabolic panel {CMP}, complete blood count {CBC}) will be performed at the screening visit.

Study groups in NCT03143816
Study groupRoleWhat they receive
Technosphere insulin (TI, Afrezza) -Treatment armActive comparatorPatients who are randomized into the TI arm will be instructed to dose before the meals and take necessary corrections at 1- and 2-hours after meals to optimize PPBG ( post prandial blood glucose)
Receives: Drug: Technosphere insulin
Insulin Aspart ( Novolog) -Control armNo interventionPatients who are randomized into the NL arm will continue using their usual prandial insulin dose before meals.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Time in Range (%) (70-180 mg/dl) With TI on CGM

    Difference between Time in range for TI group (treatment) and for Aspart group (control)

    Measured: 4 weeks

Secondary outcomes (6)

  1. Change in Post-prandial Glucose Excursion (mg/dl) (1-4 Hours After Meals) With TI

    Difference in postprandial blood glucose between treatment and control group

    Measured: 4 weeks

  2. Change in Glucose Variability (GV) (mg/dl) (Standard Deviation and/or Coefficient Variation)

    Difference of glucose variability metrics between treatment and control groups

    Measured: 4 weeks

  3. The Area Under the Curve Calculation (AUC) (Min*mg/dl) in the PPBG and PPGE,

    Difference of area under curve between treatment and control groups. ( 0 to 4 hours duration)

    Measured: 0, 1, 2, 3, 4 hours post-dose at 4 weeks

  4. Change in HbA1c (%) in One-month Treatment

    Difference in HbA1c between treatment and control group

    Measured: 4 weeks

  5. Change in Above the Target Time (%) (>180 mg/dl) on CGM

    Difference of time above range between treatment and control group

    Measured: 4 weeks

  6. Hypoglycemia Frequency (%) (Below the Target <70mg/dl) on CGM

    Difference of hypoglycemia frequency between treatment and control groups.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2017
  2. Study start30 Sep 2017
  3. Primary completion15 Dec 2017
  4. Study completion31 Jan 2018

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03143816
Sponsor's protocol ID
17-0427
Acronym
STAT
Status last verified
Jan 2022
First submitted
2 May 2017
Last updated
22 Feb 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Publishing the data after the study, presenting at national scientific meetings

Publications

  • 1. Rathbone M, Hadgraft J, Roberts M, Lane M, Leone-Bay A, Grant M. Technosphere/insulin: mimicking endogenous insulin release. In Modified-Release Drug Delivery Technology. Vol. 2, 2nd ed. Rathbone M, Hadgraft J, Roberts M, Lane M, Eds. New York, Informa Healthcare USA, Inc., 2008, p. 673-679

  • Richardson PC, Boss AH. Technosphere insulin technology. Diabetes Technol Ther. 2007 Jun;9 Suppl 1:S65-72. doi: 10.1089/dia.2007.0212.

    PubMed 17563306

  • https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf, April 2017

  • Bode BW, McGill JB, Lorber DL, Gross JL, Chang PC, Bregman DB; Affinity 1 Study Group. Inhaled Technosphere Insulin Compared With Injected Prandial Insulin in Type 1 Diabetes: A Randomized 24-Week Trial. Diabetes Care. 2015 Dec;38(12):2266-73. doi: 10.2337/dc15-0075. Epub 2015 Jul 15.

    PubMed 26180109

  • Rosenstock J, Lorber DL, Gnudi L, Howard CP, Bilheimer DW, Chang PC, Petrucci RE, Boss AH, Richardson PC. Prandial inhaled insulin plus basal insulin glargine versus twice daily biaspart insulin for type 2 diabetes: a multicentre randomised trial. Lancet. 2010 Jun 26;375(9733):2244-53. doi: 10.1016/S0140-6736(10)60632-0.

    PubMed 20609970

  • Skyler JS, Weinstock RS, Raskin P, Yale JF, Barrett E, Gerich JE, Gerstein HC; Inhaled Insulin Phase III Type 1 Diabetes Study Group. Use of inhaled insulin in a basal/bolus insulin regimen in type 1 diabetic subjects: a 6-month, randomized, comparative trial. Diabetes Care. 2005 Jul;28(7):1630-5. doi: 10.2337/diacare.28.7.1630.

    PubMed 15983312

  • Garg SK, Kelly W, Freson B, Ritchie P. Treat-to-target technosphere insulin study in adult subjects with type 1 diabetes. Poster presented at American Diabetes Association 2011 annual meeting.

  • Akturk HK, Snell-Bergeon JK, Rewers A, Klaff LJ, Bode BW, Peters AL, Bailey TS, Garg SK. Improved Postprandial Glucose with Inhaled Technosphere Insulin Compared with Insulin Aspart in Patients with Type 1 Diabetes on Multiple Daily Injections: The STAT Study. Diabetes Technol Ther. 2018 Oct;20(10):639-647. doi: 10.1089/dia.2018.0200. Epub 2018 Sep 15.

    PubMed 30207748

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Technosphere insulin in people with Diabetes Mellitus, Type 1, run by University of Colorado, Denver 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 16 inclusion and 19 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 22 Feb 2022. 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?

Yes. Results are posted in the registry (first posted 22 Feb 2022). 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 Time in Range (%) (70-180 mg/dl) With TI on CGM (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03143816, which also lists 8 linked publications.

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 22 Feb 2022.

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STAT Clinical Trial NCT03143816 | AzTrials