Recruiting
Phase 2
Phase 3

Lyumjev & Pramlintide

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT06046417

Conditions

type1diabetes

Diabetes Mellitus, Type 1

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pramlintide

Lyumjev

Automated Insulin Delivery (AID) system

Study Details

Brief summary:

The aim of this clinical trial is to investigate whether a fully automated Lyumjev-and-pramlintide delivery system improves glycemic outcomes in adults with type 1 diabetes. The main question we aim to answer is whether a Lyumjev-pramlintide fully closed loop system improves time in range compared to a hybrid closed loop system with carbohydrate counting. We also aim to find the optimal insulin to pramlintide ratio for glycemic control in the fully automated system.

In this cross-over study, patients will undergo the following three interventions in a random order:

(i) fully automated Lyumjev insulin-and-pramlintide (8 μg/u) (ii) fully automated Lyumjev insulin-and-pramlintide (10 μg/u) (iii) rapid automated Lyumjev insulin-and-placebo with carbohydrate-matched boluses

For all interventions, participants will be required to wear two Ypsomed pumps programmed by our developed EuGlide system.

Conditions

type1diabetes

Diabetes Mellitus, Type 1

Study ID

NCT06046417

Start date

Nov 30, 2023

Status verified date

Apr, 2024

Completion date

Jun, 2025

Anticipated

Primary completion date

Apr, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Individuals ≥ 18 years of age.
  • A clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes relies on the investigator's judgment; C peptide level and antibody determinations are unnecessary.
  • Using insulin pump therapy for at least three months.
  • Individuals of childbearing potential using an effective birth-control method. An individual of childbearing potential must agree to use a highly effective method of birth control.

Exclusion Criteria:

  • Current or recent use of antihyperglycemic agents other than insulin (≤ 2-week use of sodium-glucose cotransporter-2 inhibitor (SGLT2I), Metformin, etc.; ≤ 1-month for glucagon-like peptide-1 receptor agonists (GLP1-RA)).
  • Current use of glucocorticoid medication (except low, stable doses and inhaled steroids).
  • Individuals with confirmed gastroparesis.
  • Use of medication that alters gastrointestinal motility (ex: domperidone).
  • Use of hydroxyurea.
  • Planned or ongoing pregnancy.
  • Breastfeeding individuals.
  • Severe hypoglycemia requiring hospitalization in the past month. Severe hypoglycemia is defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions.
  • Diabetic ketoacidosis episode in the past month.
  • Clinically significant nephropathy, neuropathy, or retinopathy as judged by the investigator.
  • Recent (< 6 months) acute macrovascular event, e.g., acute coronary syndrome.
  • Other serious medical illnesses which are likely to interfere with study participation or the ability to complete the trial by the investigator's judgment.
  • Known hypersensitivity to the study drugs or their excipients.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fully automated Lyumjev-and-pramlintide delivery system (8 μg/u)

Lyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 8 μg of pramlintide.

experimental: Fully automated Lyumjev-and-pramlintide delivery system (10 μg/u)

Lyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 10 μg of pramlintide.

active comparator: Hybrid automated Lyumjev-and-placebo delivery system with carbohydrate-matched boluses

Lyumjev and saline placebo hybrid automated delivery system with meal announcement. Participants must input the carbohydrate content of their meals to inform the insulin bolus doses based on their pre-programmed insulin-to-carbohydrate ratios.

Interventions

Pramlintide

Pramlintide delivered in a basal-bolus manner.

Lyumjev

Lyumjev delivered in a basal-bolus manner.

Automated Insulin Delivery (AID) system

The AID system consists of a set of devices that work inter-connectedly to automate insulin (and pramlintide) delivery in response to an individual's glucose levels. It consists of a (i) Dexcom G6 glucose sensor, (ii) a smartphone-based algorithm, (iii) an insulin YpsoPump, and (iv) a pramlintide/placebo YpsoPump in a dual hormone configuration.

Primary outcome measure

  • Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L). [ Time Frame: 18 days ]

Central Contacts and Locations

Central contacts

Joelle Doumat, BSc.

832-798-3648joelle.doumat@mail.mcgill.ca

Locations

Research Institute of the McGill University Health Center

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Joelle Doumat, BSc.

832-798-3648joelle.doumat@mail.mcgill.ca

Principal Investigator:

Michael Tsoukas, M.D

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Apr 18, 2024

Last verified

Apr, 2024

Keywords

  • Pramlintide
  • fully automated delivery system
  • artificial pancreas
  • Insulin
  • Lyumjev
  • fully closed loop
  • adjunctive

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2024-04-18.