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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243629
Recruitment Status : Not yet recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McGill University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Type 1 Diabetes Postprandial Hyperglycemia Drug: Rapid-Acting Insulin Drug: Placebo Drug: Pramlintide Acetate Device: Artificial Pancreas Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Treatment
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.
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022


Arm Intervention/treatment
Experimental: Rapid Insulin-Plus-Pramlintide
Rapid insulin and pramlintide infusion in two insulin pumps
Drug: Rapid-Acting Insulin
Novorapid or Humalog insulin delivered in a basal-bolus manner.

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

Device: Artificial Pancreas
Tandem insulin pump, Dexcom G5 sensor, Nexus 5 cellphone running the iMAP algorithm.

Placebo Comparator: Rapid Insulin-Plus-Placebo
Rapid insulin and placebo (saline) infusion in two insulin pumps
Drug: Rapid-Acting Insulin
Novorapid or Humalog insulin delivered in a basal-bolus manner.

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

Device: Artificial Pancreas
Tandem insulin pump, Dexcom G5 sensor, Nexus 5 cellphone running the iMAP algorithm.




Primary Outcome Measures :
  1. Time in target range [ Time Frame: 4 weeks ]
    Time each participant spent with glucose level in target range (3.9 - 10.0 mmol/L)


Secondary Outcome Measures :
  1. Time between 3.9 - 7.8 mmol/L [ Time Frame: 4 weeks ]
    Percentage of time each participant spent with glucose levels between 3.9 - 7.8 mmol/L

  2. Time below 3,9, 3.3, and 2.8 mmol/L [ Time Frame: 4 weeks ]
    Percentage of time each participant spent with glucose levels below 3.9, 3.3, and 2.8 mmol/L

  3. Time above 7.8, 10.0, 13.9, 16.7 mmol/L [ Time Frame: 4 weeks ]
    Percentage of time each participant spent with glucose levels above 7.8, 10.0, 13.9, and 16.7 mmol/L

  4. Mean glucose level [ Time Frame: 4 weeks ]
    Each participant's mean glucose level

  5. Total insulin delivery [ Time Frame: 4 weeks ]
    Each participant's total insulin delivery

  6. Standard deviation and coefficient of variance [ Time Frame: 4 weeks ]
    Each participant's standard deviation and coefficient of variance of glucose levels as a measure of glucose variability

  7. Gastrointestinal symptoms [ Time Frame: 4 weeks ]
    Number of each participant's gastrointestinal symptoms

  8. Number of hypoglycemia events [ Time Frame: 4 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed and dated written informed consent
  2. Males and females ≥ 18 years of age
  3. HbA1c ≤ 11% (this is so we also include patient that are potentially missing some meal boluses)
  4. Insulin pump use for at least 6 months and actively performing carbohydrate counting
  5. 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.
  6. 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.

Exclusion Criteria:

  1. Current total daily dose < 0.4 units/kg (we wish to exclude participants who would still be considered in honeymoon period).
  2. Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 inhibitors, GLP-1 agonists, Metformin, Acarbose, etc.…).
  3. Current use of glucocorticoid medication (except low stable dose and inhaled steroids).
  4. Anticipated need to use acetaminophen during study participation
  5. Use of medication that alters gastrointestinal motility.
  6. Planned or ongoing pregnancy.
  7. Breastfeeding individuals.
  8. Severe hypoglycemic episode within 3 months of admission.
  9. Severe diabetes ketoacidosis episode within 3 months of admission.
  10. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
  11. Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  12. Known hypersensitivity to any of the study drugs or their excipients.
  13. Individuals with confirmed gastroparesis.
  14. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
  15. In the opinion of the investigator, a participant who is unable or unwilling to observe the contraindications of the study devices.
  16. Unable to travel to research center within 3h if needed during study interventions
  17. Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).

Discontinuation Criteria:

  1. Failure to comply with the protocol.
  2. Pregnancy.
  3. After an event which the PI believes it is not in the best interest for the patient to continue the trial.
  4. The subject wants to withdraw consent to participate
  5. The subject needs to take any medications that are contraindicated in the study
  6. The subject can no longer be treated with the study medication for other reasons
  7. The subject experiences severe hypoglycaemia requiring hospitalization or repeated hypoglycaemia requiring assistance to treat.
  8. The subject fails to follow instructions given about the trial
  9. The Study Team has decided to discontinue or terminate the clinical trial prematurely

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243629


Contacts
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Contact: Emilie Palisaitis, MEng, BSc 5146098961 emilie.palisaitis@mcgill.ca

Locations
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Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Contact: Emilie Palisaitis, MEng, BSc       emilie.palisaitis@mcgill.ca   
Principal Investigator: Michael Tsoukas, M.D.         
Sub-Investigator: Ahmad Haidar, Ph.D.         
Sub-Investigator: Laurent Legault, M.D.         
Sub-Investigator: Jean-François Yale, M.D.         
Sponsors and Collaborators
McGill University
Canadian Institutes of Health Research (CIHR)
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Responsible Party: McGill University
ClinicalTrials.gov Identifier: NCT04243629    
Other Study ID Numbers: 2020-6258
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by McGill University:
Artificial pancreas
Closed-loop system
Amylin
Pramlintide
Type 1 Diabetes
Glycemic control
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pramlintide
Insulin, Short-Acting
Pancrelipase
Hypoglycemic Agents
Physiological Effects of Drugs
Gastrointestinal Agents