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 (STAT)

January 28, 2022 updated by: University of Colorado, Denver

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Aurora, Colorado, United States, 80045
        • Barbara Davis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed informed consent before any study-related activities,
  2. Male or female aged 18-70 years,
  3. Type 1 diabetes mellitus (T1D) duration more than six months
  4. Treatment with multiple daily injections (MDI) for at least three months before screening visit; stable insulin dose for the last one month,
  5. 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,
  6. A1c between 6.5 to 10%,
  7. 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),
  8. BMI ≤35 kg/m2,
  9. Ability and willingness to adhere to the protocol including clinical and phone visits and 4-week-long CGM wear,
  10. Using insulin glargine or insulin degludec as basal insulin,
  11. Able to use and understand CGM data,
  12. Willing to complete phone and clinic visits,
  13. Patients who eat three main meals in a day (breakfast, lunch, and dinner),
  14. Patients who use insulin-carb ratio for bolus,
  15. Ability to speak, read, and write English, and
  16. Patients prandial insulin need must be <18 units per meal

Exclusion Criteria:

  1. Use of any other diabetic medication other than allowed in the protocol,
  2. Pregnant or intention to become pregnant during the study, or not using adequate birth control methods,
  3. Severe unexplained hypoglycemia requiring emergency treatment in the previous three months,
  4. Use of systemic or inhaled corticosteroids,
  5. History of hemoglobinopathies,
  6. Diagnosis of anemia,
  7. Post-renal transplantation, currently undergoing dialysis, creatinine >2.0 mg/dl or a calculated creatinine clearance of <50 mL/min,
  8. Advanced or unstable retinopathy needing laser procedure or vitrectomy,
  9. History of pancreatitis,
  10. Extensive skin changes/diseases that inhibit wearing a sensor on normal skin,
  11. Known allergy to adhesives,
  12. Known allergy to study medication,
  13. Participation in another investigational study protocol within 30 days before enrollment,
  14. 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,
  15. Active smokers,
  16. Marijuana users,
  17. Insulin pump users,
  18. Using insulin detemir or NPH as basal insulin, and
  19. 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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Technosphere insulin (TI, Afrezza) -Treatment arm
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 ( post prandial blood glucose)
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.
No Intervention: Insulin Aspart ( Novolog) -Control arm
Patients who are randomized into the NL arm will continue using their usual prandial insulin dose before meals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Time in Range (%) (70-180 mg/dl) With TI on CGM
Time Frame: 4 weeks
Difference between Time in range for TI group (treatment) and for Aspart group (control)
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Post-prandial Glucose Excursion (mg/dl) (1-4 Hours After Meals) With TI
Time Frame: 4 weeks
Difference in postprandial blood glucose between treatment and control group
4 weeks
Change in Glucose Variability (GV) (mg/dl) (Standard Deviation and/or Coefficient Variation)
Time Frame: 4 weeks
Difference of glucose variability metrics between treatment and control groups
4 weeks
The Area Under the Curve Calculation (AUC) (Min*mg/dl) in the PPBG and PPGE,
Time Frame: 0, 1, 2, 3, 4 hours post-dose at 4 weeks
Difference of area under curve between treatment and control groups. ( 0 to 4 hours duration)
0, 1, 2, 3, 4 hours post-dose at 4 weeks
Change in HbA1c (%) in One-month Treatment
Time Frame: 4 weeks
Difference in HbA1c between treatment and control group
4 weeks
Change in Above the Target Time (%) (>180 mg/dl) on CGM
Time Frame: 4 weeks
Difference of time above range between treatment and control group
4 weeks
Hypoglycemia Frequency (%) (Below the Target <70mg/dl) on CGM
Time Frame: 4 weeks
Difference of hypoglycemia frequency between treatment and control groups.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2017

Primary Completion (Actual)

December 15, 2017

Study Completion (Actual)

January 31, 2018

Study Registration Dates

First Submitted

May 2, 2017

First Submitted That Met QC Criteria

May 3, 2017

First Posted (Actual)

May 8, 2017

Study Record Updates

Last Update Posted (Actual)

February 22, 2022

Last Update Submitted That Met QC Criteria

January 28, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Publishing the data after the study, presenting at national scientific meetings

Drug and device information, study documents

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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