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Diabetes Mellitus, Type 1NCT04243629

Co-administration of Pramlintide and Insulin Via an Automated Dual-hormone Artificial Pancreas System in Adults With Type 1 Diabetes

A study testing Rapid-Acting Insulin, Pramlintide Acetate and Artificial Pancreas in people with Diabetes Mellitus, Type 1 and Type 1 Diabetes, run by McGill University at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

One of the main challenges in maintaining tight glucose control in a closed-loop system occurs at meal times. Amylin is a gluco-regulatory beta-cell hormone that is co-secreted with insulin in response to nutrient stimuli, and is deficient in patients with type 1 diabetes. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rapid-Acting Insulin, Pramlintide Acetate and Artificial Pancreas
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
1 siteCanada
Study dates
12 Nov 2021to Apr 2024
Phase
Interventional
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

  • Signed and dated written informed consent
  • Males and females ≥ 18 years of age
  • HbA1c ≤ 11% (this is so we also include patient that are potentially missing some meal boluses)
  • Insulin pump use for at least 6 months and actively performing carbohydrate counting
  • Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of T1D is based on the investigator's clinical judgment; C peptide level and antibody determinations are not planned.
  • Women of child-bearing potential must be ready and able to use a highly effective method of birth control. Women of childbearing potential are females who have experienced [the first occurrence of menstruation] and do not meet the criteria for women not of childbearing potential. Women not of childbearing potential are females who are permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.

Who cannot join

  • Current total daily dose < 0.4 units/kg (we wish to exclude participants who would still be considered in honeymoon period).
  • Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 inhibitors, GLP-1 agonists, Metformin, Acarbose, etc.…).
  • Current use of glucocorticoid medication (except low stable dose and inhaled steroids).
  • Anticipated need to use acetaminophen during study participation
  • Use of medication that alters gastrointestinal motility.
  • Planned or ongoing pregnancy.
Show all 27Show fewer
  • Breastfeeding individuals.
  • Severe hypoglycemic episode within 3 months of admission.
  • Severe diabetes ketoacidosis episode within 3 months of admission.
  • Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
  • Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  • Known hypersensitivity to any of the study drugs or their excipients.
  • Individuals with confirmed gastroparesis.
  • Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
  • In the opinion of the investigator, a participant who is unable or unwilling to observe the contraindications of the study devices.
  • Unable to travel to research center within 3h if needed during study interventions
  • Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).
  • Discontinuation Criteria:
  • Failure to comply with the protocol.
  • Pregnancy.
  • After an event which the PI believes it is not in the best interest for the patient to continue the trial.
  • The subject wants to withdraw consent to participate
  • The subject needs to take any medications that are contraindicated in the study
  • The subject can no longer be treated with the study medication for other reasons
  • The subject experiences severe hypoglycaemia requiring hospitalization or repeated hypoglycaemia requiring assistance to treat.
  • The subject fails to follow instructions given about the trial
  • The Study Team has decided to discontinue or terminate the clinical trial prematurely

Trial locations and contacts

1 site in 1 country.

Elisa Cohen, BSs contact

6472372366

elisa.cohen@mail.mcgill.ca

Canada1 site, 1 recruiting

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

    Elisa Cohen, BSc, elisa.cohen@mail.mcgill.ca

    Michael Tsoukas, M.D.

    Recruiting

Other trials in Canada

About this study

Official title: Co-administration of Pramlintide and Insulin Via an Automated Dual-hormone Artificial Pancreas System to Regulate Glucose Levels in Adults Living With Type 1 Diabetes: a Randomized, Controlled, Crossover Trial.

One of the main challenges in maintaining tight glucose control in a closed-loop system occurs at meal times. Amylin is a gluco-regulatory beta-cell hormone that is co-secreted with insulin in response to nutrient stimuli, and is deficient in patients with type 1 diabetes. Amylin, in the postprandial period, contributes to regulating glucose levels by delaying gastric emptying, suppressing nutrient-stimulated glucagon secretion, and increasing satiety. Pramlintide is a synthetic analog of the hormone amylin. A closed-loop system that delivers both insulin and pramlintide, based on glucose sensor readings, has the potential to better normalize glucose levels, especially during the post-prandial period.

The aim of this project is to assess whether co-administration of pramlintide with rapid insulin in an artificial pancreas system will improve glycemic control in adults with Type 1 Diabetes.

Being tested
Rapid-Acting Insulin, Placebo, Pramlintide Acetate, Artificial Pancreas
Keywords
Artificial pancreas, Closed-loop system, Amylin, Pramlintide, Type 1 Diabetes, Glycemic control
Medical subject headings
Diabetes Mellitus, Type 1, Hyperglycemia

What participants receive

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

  • Rapid-Acting InsulinDrug

    Novorapid or Humalog insulin delivered in a basal-bolus manner.

  • PlaceboDrug

    Placebo (saline) delivered in a basal-bolus manner at a fixed ratio with insulin.

  • Pramlintide AcetateDrug

    Pramlintide acetate delivered in a basal-bolus manner at a fixed ratio with insulin.

  • Artificial PancreasDevice

    Tandem insulin pump, Dexcom G6 sensor, study smartphone running the iMAP algorithm.

Study groups in NCT04243629
Study groupRoleWhat they receive
Rapid Insulin-Plus-PramlintideExperimentalRapid insulin and pramlintide infusion in two insulin pumps
Receives: Drug: Rapid-Acting Insulin; Drug: Pramlintide Acetate; Device: Artificial Pancreas
Rapid Insulin-Plus-PlaceboPlacebo comparatorRapid insulin and placebo (saline) infusion in two insulin pumps
Receives: Drug: Rapid-Acting Insulin; Drug: Placebo; Device: Artificial Pancreas

What is being measured

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

  1. Time in target range

    Time each participant spent with glucose level in target range (3.9 - 10.0 mmol/L)

    Measured: 4 weeks

Secondary outcomes (8)

  1. Time between 3.9 - 7.8 mmol/L

    Percentage of time each participant spent with glucose levels between 3.9 - 7.8 mmol/L

    Measured: 4 weeks

  2. Time below 3,9, 3.3, and 2.8 mmol/L

    Percentage of time each participant spent with glucose levels below 3.9, 3.3, and 2.8 mmol/L

    Measured: 4 weeks

  3. Time above 7.8, 10.0, 13.9, 16.7 mmol/L

    Percentage of time each participant spent with glucose levels above 7.8, 10.0, 13.9, and 16.7 mmol/L

    Measured: 4 weeks

  4. Mean glucose level

    Each participant's mean glucose level

    Measured: 4 weeks

  5. Total insulin delivery

    Each participant's total insulin delivery

    Measured: 4 weeks

  6. Standard deviation and coefficient of variance

    Each participant's standard deviation and coefficient of variance of glucose levels as a measure of glucose variability

    Measured: 4 weeks

  7. Gastrointestinal symptoms

    Number of each participant's gastrointestinal symptoms

    Measured: 4 weeks

  8. Number of hypoglycemia events

    Each participant's number of hypoglycemia events defined as at least 15 min below 3.0 mmol/L with the end of the event being 15 minutes > 3.9 mmol/L.

    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 posted28 Jan 2020
  2. Study start12 Nov 2021
  3. Primary completionApr 2024 (estimated)
  4. Study completionApr 2024 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
This is a two-way, randomized, open-label, controlled, crossover trial to compare the following strategies: (i) Rapid insulin-plus-Pramlintide closed-loop delivery (ii) Rapid insulin-plus-Placebo closed-loop delivery
Masking
None (open label)
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04243629
Sponsor's protocol ID
2020-6258
Status last verified
Mar 2023
First submitted
24 Jan 2020
Last updated
15 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The raw data (i.e., insulin delivery, glucose levels, individual participant data) and informed consent form could be shared by the corresponding author, ahmad.haidar@mcgill.ca, upon reasonable request for academic purposes, subject to Material Transfer Agreement and approval of McGill University Health Center's Research Ethics Board. All data shared will be deidentified. Study protocol is available with publication.

Questions about this trial

What is this clinical trial studying?

A study testing Rapid-Acting Insulin, Pramlintide Acetate and Artificial Pancreas in people with Diabetes Mellitus, Type 1 and Type 1 Diabetes, run by McGill University at 1 site in Canada.

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 6 inclusion and 27 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 15 Mar 2023. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

Contact Elisa Cohen, BSs (6472372366, elisa.cohen@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time in target range (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 NCT04243629.

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 15 Mar 2023.

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