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Type 1 Diabetes MellitusPhase 3NCT03977727

FIasp® vs. Novolog® in Type 1 Diabetics Using 670G Medtronic Pump

A Phase 3 study testing Fiasp®, Novolog® and 670G hybrid closed loop continuous subcutaneous insulin infusion system in people with Type 1 Diabetes Mellitus, run by Texas Diabetes & Endocrinology, P.A. 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 exploratory, single-center, randomized, open label, active-controlled, complete cross-over trial comparing safety and efficacy of Fiasp® versus NovoLog® when used in the Medtronic MiniMed 670G system in subjects with T1DM. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Fiasp®, Novolog® and 670G hybrid closed loop continuous subcutaneous insulin infusion system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
11 Jun 2019to 20 Apr 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

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
  • Male or female, age ≥18 years at the time of signing informed consent
  • Documented diagnoses of T1DM ≥1 year prior to the day of screening
  • Using the Medtronic pump Minimed 670G for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least 30 days prior to screening and willing to continue using their personal Medtronic Minimed 670G and CSII for insulin treatment throughout the trial.
  • Ability and willingness to use the same insulin infusion sets throughout the trial
  • Using the same insulin for at least 30 days prior to screening
Show all 9Show fewer
  • HbA1c < 8.5% as assessed by local laboratory at screening
  • BMI ≤ 35.0 kg/m2 at screening
  • Ability and willingness to adhere to the protocol including performing SMPG profiles, attending visits, utilizing the auto mode feature of the pump for at least 80 % of the time during the study, and completing meal tests

Who cannot join

  • Known or suspected hypersensitivity to trial products or related products
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
  • Participation in another clinical trial within 28 days before the screening visit. Note: clinical trials do not include non-interventional studies
  • Anticipated significant change in lifestyle (e.g. eating, exercise or sleeping pattern) throughout the trial
  • Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischemic attack within the past 180 days prior to the day of screening
  • Subjects classified as being in New York Heart Association (NYHA) Class IV at screening
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  • Planned coronary, carotid or peripheral artery revascularization known on the day of screening.
  • Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic
  • ≥180 mmHg or diastolic ≥110 mmHg) at screening
  • Impaired liver function, defined as ALT ≥ 2.5 times upper normal limit at screening
  • Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 45 ml/min/1.73 m2
  • Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism in the opinion of the Investigator
  • Proliferative retinopathy or maculopathy requiring acute treatment at the time of screening
  • History of hospitalization for ketoacidosis ≤180 days prior to the day of screening
  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 30 days before screening
  • Presence of malignant neoplasms at the time of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.
  • Reoccurring Severe hypoglycemia while on the Medtronic Minimed 670G in the investigators opinion
  • Any condition which, in the opinion of the Investigator, might jeopardize Subject's safety or compliance with the protocol
  • -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Texas Diabetes & Endocrinology

    Austin, Texas, 78731

Other trials in United States

About this study

Official title: An Exploratory, Single-center, Randomized, Open Label, Active-control, Cross-over Trial Comparing the Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart (Fiasp®) Compared to NovoLog® Used in the Medtronic 670G Closed Loop System in Adults With Type 1 Diabetes

This is an exploratory, single-center, randomized, open label, active-controlled, complete cross-over trial comparing safety and efficacy of Fiasp® versus NovoLog® when used in the Medtronic MiniMed 670G system in subjects with T1DM.

Read the detailed description

This study is being performed to compare Fiasp® in terms of glycemic control with a focus on post-prandial 1-hour plasma glucose level and system-based outcomes to NovoLog® insulin when used in the Medtronic mini Med 670G HCL system (operating in auto-mode) in patients with type 1 diabetes. The investigator's hypothesis is that post prandial glucoses will be lower and time in range will be greater during the Fiasp® treatment period.

Subjects will have a 2 week screening period, 14 week treatment period and 30 Day follow up period. After at least 7 weeks on treatment period one they will crossover to treatment period two on the opposite treatment for 7 additional weeks.

Being tested
Fiasp®, Novolog®, 670G hybrid closed loop continuous subcutaneous insulin infusion system
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • Fiasp®Drug

    Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system

  • Novolog®Drug

    Also called Aspart

    Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system

  • 670G hybrid closed loop continuous subcutaneous insulin infusion systemDevice

    Also called Medtronic 670G pump

    CSII

Study groups in NCT03977727
Study groupRoleWhat they receive
Fiasp/NovologExperimental7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion
Receives: Drug: Fiasp®; Drug: Novolog®; Device: 670G hybrid closed loop continuous subcutaneous insulin infusion system
Novolog/FiaspExperimental7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion
Receives: Drug: Fiasp®; Drug: Novolog®; Device: 670G hybrid closed loop continuous subcutaneous insulin infusion system

What is being measured

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

  1. 1-Hour Change in Postprandial Plasma Glucose (PPG)

    Change was calculated as the PPG value at 1 hour minus the PPG value at baseline (time -2 minutes) during meal test

    Measured: 6th week of therapy

Secondary outcomes (19)

  1. 2-Hour Change in Postprandial Plasma Glucose (PPG)

    Change was calculated as the value at 2 hour minus the value at baseline during meal test

    Measured: 6th week of therapy

  2. Percentage of Time Spent Between Below 70 mg/dL

    Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)

    Measured: Weeks 1 through 6, Weeks 8 through 13

  3. Percentage of Time Spent Between 70 mg/dL and 180 mg/dL

    Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)

    Measured: Weeks 1 through 6, Weeks 8 through 13

  4. Percentage of Time Spent Above 200 mg/dL

    Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)

    Measured: Weeks 1 through 6, Weeks 8 through 13

  5. Percentage of Time Spent in Hypoglycemia (40 mg/dL - 54 mg/dL)

    Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)

    Measured: Weeks 1 through 6, Weeks 8 through 13

  6. Percentage of Time Spent in Severe Hypoglycemia (> 40 mg/dL)

    Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)

    Measured: Weeks 1 through 6, Weeks 8 through 13

  7. 1,5 Anhydroglucitol Levels

    1,5 anhydroglucitol levels were measured on the 6th week of each therapy

    Measured: Week 6, Week 13

  8. Fructosamine Levels

    Cumulative glycemic control expressed in fructosamine levels (micromol/Liter) were measured on the 6th week of each therapy

    Measured: Week 6, Week 13

  9. HbA1c

    Cumulative glycemic control expressed in HbA1c% measured on the 6th week of each therapy

    Measured: Week 6, Week 13

  10. Insulin Use - Change in Daily Dose

    Change was calculated as the value on the last day of therapy minus the value on the 1st day of therapy in each period

    Measured: Weeks 1 through 6, Weeks 8 through 13

  11. Insulin Use - Bolus

    Change in %bolus insulin (units) as the value on the last day of therapy minus the value on the 1st day of therapy in each period

    Measured: Weeks 1 through 6, Weeks 8 through 13

  12. Insulin Use - Basal

    Change in %basal insulin (units) as the value on the last day of therapy minus the value on the 1st day of therapy in each period

    Measured: Weeks 1 through 6, Weeks 8 through 13

  13. Insulin Use - Automatic Basal Insulin

    Average amount per day (units) calculated for each participant under each therapy

    Measured: Weeks 1 through 6, Weeks 8 through 13

  14. Insulin Pump - Active Insulin Time

    Average time per day (hours) calculated for each participant under each therapy

    Measured: Weeks 1 through 6, Weeks 8 through 13

  15. Insulin Pump - Auto Mode

    Percentage of time spent in auto-mode after calibration under each therapy

    Measured: Weeks 3 through 6, Weeks 10 through 13

  16. Insulin Pump - Manual Mode

    Percentage of time spent in manual-mode after calibration under each therapy

    Measured: Weeks 3 through 6, Weeks 10 through 13

  17. Change in Carbohydrate Ratio

    Change was calculated as the carbohydrate ratio on the last day of therapy minus the carbohydrate ratio on the 1st day of therapy in each period

    Measured: Weeks 1 through 6, Weeks 8 through 13

  18. Infusion Site Reactions

    Number of Infusion site reactions reported by patient

    Measured: 14 week treatment period

  19. Pump Occlusions

    Number of Occlusion events reported by patient

    Measured: 14 week treatment period

Timeline

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

  1. First posted6 Jun 2019
  2. Study start11 Jun 2019
  3. Primary completion9 Mar 2020
  4. Study completion20 Apr 2020

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03977727
Sponsor's protocol ID
U1111-1213-9104
Status last verified
Aug 2020
First submitted
17 Apr 2019
Last updated
29 Sep 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes

Publications

  • Ozer K, Cooper AM, Ahn LP, Waggonner CR, Blevins TC. Fast Acting Insulin Aspart Compared with Insulin Aspart in the Medtronic 670G Hybrid Closed Loop System in Type 1 Diabetes: An Open Label Crossover Study. Diabetes Technol Ther. 2021 Apr;23(4):286-292. doi: 10.1089/dia.2020.0500. Epub 2021 Mar 8.

    PubMed 33090016

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fiasp®, Novolog® and 670G hybrid closed loop continuous subcutaneous insulin infusion system in people with Type 1 Diabetes Mellitus, run by Texas Diabetes & Endocrinology, P.A. 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 9 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 29 Sep 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 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 9 Sep 2020). 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?

1-Hour Change in Postprandial Plasma Glucose (PPG) (time frame: 6th week of therapy). 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 NCT03977727, which also lists 1 linked publication.

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 29 Sep 2020.

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