Alleviating Carbohydrate Counting for Patients with Type-1 Diabetes Using a Closed Loop System with Weekly Subcutaneous Semaglutide

Last updated: December 13, 2024
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Overall Status: Active - Recruiting

Phase

2/3

Condition

Diabetes Mellitus, Type 1

Diabetes Mellitus Types I And Ii

Diabetes Prevention

Treatment

Semaglutide with 4 meal strategies

Placebo with 4 meal strategies

Clinical Study ID

NCT06387199
2024-10227
  • All Genders

Study Summary

A closed-loop insulin system, often labelled the "artificial pancreas" (AP), consists of an insulin pump, a continuous glucose monitor, and an interface coordinating between them to regulate insulin dosage based on glucose levels. Primarily designed for managing type 1 diabetes, this system has demonstrated significant benefits in previous studies. Yet, despite these advantages, certain challenges persist.

Semaglutide, utilized in treating type 2 diabetes and obesity, is a once-weekly injectable medication that elevates levels of a gastrointestinal hormone known as Glucagon-Like Peptide-1 (GLP-1). This hormone alters gastric emptying, inhibits glucagon release, and reduces appetite. While not officially sanctioned for type 1 diabetes treatment in North America, studies have explored its efficacy as an adjunctive therapy alongside insulin, yielding favorable outcomes in blood glucose regulation. Comparable drugs like liraglutide and exenatide have been employed in type 1 diabetes treatment as well, albeit with less pronounced glucose-regulating effects compared to semaglutide, even in type 2 diabetes.

The goal of this 50-week randomized placebo-controlled crossover 2x4 factorial designed trial is to assess whether commercial automated insulin delivery (AID) systems using rapid-acting insulin with adjunct weekly injections of semaglutide (at the maximally tolerated dose) can replace carbohydrate counting with simple meal announcements (SMA) without degrading glucose control.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. At least 18 years of age

  2. A clinical diagnosis of T1D for at least one year, as per their treating diabetesphysician in agreement with the primary investigator's clinical judgment (confirmatory C-peptide and antibodies will not be required)

  3. Minimum 3-month use of a commercial advanced automated insulin delivery system. 4.4.Agreement to use an effective method of birth control for individuals withchild-bearing potential. Child-bearing potential refers to participants of thefemale sex post-menarche who have not reached menopause and who do not have amedical condition causing sterility (e.g., hysterectomy). Post-menopausal staterefers to the absence of menses for 12 months without any alternative cause.

Exclusion

Exclusion Criteria:

  1. Use of GLP1-RAs within the last 4 weeks.

  2. Use of any anti-hyperglycemic agent other than insulin within the last 2 weeks.

  3. Planned or ongoing pregnancy

  4. Breastfeeding

  5. Severe hypoglycemic episode within the last 3 months, defined as an event whereglucose was < 4 mmol/L resulting in seizure, loss of consciousness, or need topresent to the emergency department

  6. Severe diabetic ketoacidosis (DKA) within the last 6 months ("severe" referring toneed to present to medical attention and requirement of intravenous insulin)

  7. Prior history of acute pancreatitis, chronic pancreatitis, or gallbladder disease

  8. Personal or family history of medullary thyroid cancer or multiple endocrineneoplasia type 2

  9. Severe impairment of renal function with eGFR <30 mL/min/1.73 m2 (using CKD-EPIformula), measured within the last 12 months

  10. Clinically significant diabetic retinopathy or gastroparesis, as per the clinicaljudgment of the investigator

  11. Bariatric surgery within the last 6 months.

  12. A serious medical or psychiatric illness that is likely to interfere with studyparticipation as per the judgment of the investigator (e.g. cirrhosis, activecancer, decompensated schizophrenia).

  13. Body mass index ≤ 21 kg/m2

  14. Inability or unwillingness to comply to safe diabetes management in the view of thestudy group (e.g. inappropriate treatment of hypoglycemia or lack thereof)

  15. Concern for safety of the participant, as per the clinical judgment of the primaryinvestigator

Study Design

Total Participants: 26
Treatment Group(s): 2
Primary Treatment: Semaglutide with 4 meal strategies
Phase: 2/3
Study Start date:
December 01, 2024
Estimated Completion Date:
January 31, 2027

Study Description

The main questions this study aims to answer are:

  • Can weekly injections of semaglutide at the maximum tolerated dose in individuals with T1D on closed-loop therapy with SMA and rapid-acting insulin result in a non-inferior time spent in target range (3.9-10 mmol/L) compared to weekly placebo injections on closed-loop system with full carbohydrate counting.

  • Can weekly injections of semaglutide at the maximum tolerated dose, in combination with ultra-rapid actin insulin (Lyumjev);

    1. Eliminate carbohydrate counting and any meal announcement (i.e fully closed-loop) in people with T1D on closed-loop therapy without degrading glucose control.

    2. Be more effective in substituting carbohydrate counting with SMA in people with T1D on closed-loop therapy compared with traditional rapid-acting insulin.

Participants will be asked to undergo two subsequent blinded drug interventions; one with semaglutide and the other with placebo. Both interventions include 4 meal strategies each with a 3-week duration; full carbohydrate counting with rapid-acting insulin, SMA with rapid-acting insulin, SMA with Lyumjev and fully closed-loop system with Lyumjev.

Connect with a study center

  • Research Institute of the McGill University Health Centre

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

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