Recruiting
Phase 3

Semaglutide & Empagliflozin

Sponsor:

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

Code:

NCT06894784

Conditions

Diabetes Type 1

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intervention Period 1: Semaglutide + Empagliflozin

Intervention Period 2: Semaglutide + Empagliflozin Placebo

Intervention Period 3: Semaglutide Placebo + Empagliflozin

Intervention Period 4: Semaglutide Placebo + Empagliflozin Placebo

Study Details

Brief summary:

The goal of this clinical trial is to learn if Empagliflozin and Semaglutide, individually and combined, added to Automated Insulin Delivery (AID) works to improve time-in-range in adults living with Type 1 Diabetes. It will also evaluate the safety of Empagliflozin and Semaglutide in this context.

The primary hypothesis of this study is :

- The combination therapy of semaglutide and empagliflozin will increase time-in-range compared to placebo when added to AID therapy.

The secondary hypotheses are :

  • The combination therapy of semaglutide and empagliflozin will increase time-in-range compared to semaglutide alone when added to AID therapy.
  • The combination of semaglutide and empagliflozin will increase time-in-range compared to empagliflozin alone when added to AID therapy.

In this study, the research team will compare Empagliflozin and Semaglutide to a placebo (a look-alike substance that contains no drug) to see if they improve time-in-range.

This study has four groups:

Group 1: semaglutide injection + empagliflozin tablet. Group 2: semaglutide injection + placebo tablet. Group 3: placebo injection + empagliflozin tablet. Group 4: placebo injection + placebo tablet.

This is a 2x2 factorial crossover study. This means that all participants will undergo both injection intervention (placebo and semaglutide) arms. Within each injection arm, participants will take both tablets (placebo and empagliflozin). By the end of the study, every participant will have taken part in each study group.

Conditions

Diabetes Type 1

Study ID

NCT06894784

Start date

Apr, 2025

Status verified date

Mar, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

The inclusion criteria at the time of enrollment are:

  • Males and females aged 18 or older.
  • Clinical diagnosis of T1D for at least one year.
  • Use of AID system for at least three months.
  • Body Mass Index (BMI) ≥ 23 kg/m2.

The exclusion criteria are:

  • Use of GLP1-RA within one month of admission.
  • Use of SGLT2i within two weeks of admission.
  • Planned or ongoing pregnancy.
  • Breastfeeding.
  • Severe hypoglycemic episode within three months of admission (defined as an event where blood glucose levels were < 4.0 mmol/L, resulting in seizure, loss of consciousness, or the need to present to the emergency department).
  • Diabetic ketoacidosis episode within six months of admission.
  • History of acute pancreatitis, chronic pancreatitis, or gallbladder disease.
  • Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.
  • Severe impairment of renal function with an eGFR < 30 mL/min/1.73 m2 within four months of admission. eGFR will be computed using the CKD-EPI method.
  • Clinically significant diabetic retinopathy or gastroparesis, as per the investigator's judgement.
  • Bariatric surgery within six months of admission.
  • A serious medical or psychiatric illness that would likely interfere with participation in this study, as per the investigator's judgement.
  • Inability or unwillingness to comply with safe diabetes management practices, as per the investigator's judgment.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Semaglutide, Ozempic® (at maximum tolerated dose) + Automated Insulin Delivery system

Semaglutide is a Glucagon-Like Peptide 1 Receptor Agonist. It stimulates GLP1 in the body, which allows for increased satiety, reduced glucagon levels, delayed gastric emptying, and in some, increased insulin secretion. It is a once per week subcutaneous injection.

Participants will self-administer the colourless solution subcutaneously in the abdomen, thighs, or upper arms once weekly per the dosing schedule below.

Weeks 1-4 : 0.25 mg (0.19 mL) Weeks 5-8 : 0.50 mg (0.38 mL) Weeks 9-12 : 1.0 mg (0.74 mL) Weeks 13-22 : 1.0 mg (0.74 mL)

To match the recommendation from the product monograph and to ensure a steady state is reached before initiating the evaluation period, study drugs will be titrated for 12 weeks.

active comparator: Placebo + Automated Insulin Delivery system

Participants will self-administer the colourless solution subcutaneously in the abdomen, thighs, or upper arms once weekly per the dosing schedule below.

Weeks 1-4 : 0.19 mL Weeks 5-8 : 0.38 mL Weeks 9-12 : 0.74 mL Weeks 13-22 : 0.74 mL

To match the recommendation from the product monograph and to ensure a steady state is reached before initiating the evaluation period, study drugs will be titrated for 12 weeks.

Interventions

Intervention Period 1: Semaglutide + Empagliflozin

Semaglutide Injection: Subcutaneous injection, titrated over 12 weeks to a stable dose (1 mg), administered weekly.

Empagliflozin Tablet: Oral tablet (2.5 mg), administered daily.

Automated Insulin Delivery (AID) System: Continuous use of the participant's personal commercial AID system.

Intervention Period 2: Semaglutide + Empagliflozin Placebo

Semaglutide Injection: Subcutaneous injection, titrated over 12 weeks to a stable dose (1 mg), administered weekly.

Empagliflozin Placebo Tablet: Oral placebo tablet, matched in appearance to empagliflozin (2.5 mg), administered daily.

Automated Insulin Delivery (AID) System: Continuous use of the participant's personal commercial AID system.

Intervention Period 3: Semaglutide Placebo + Empagliflozin

Semaglutide Placebo Injection: Subcutaneous placebo injection (titrated over 12 weeks to a stable 1 mg dose), matched in appearance to semaglutide, administered weekly.

Empagliflozin Tablet: Oral tablet (2.5 mg), administered daily.

Automated Insulin Delivery (AID) System: Continuous use of the participant's personal commercial AID system.

Intervention Period 4: Semaglutide Placebo + Empagliflozin Placebo

Semaglutide Placebo Injection: Subcutaneous placebo injection (titrated over 12 weeks to a stable 1 mg dose), matched in appearance to semaglutide, administered weekly.

Empagliflozin Placebo Tablet: Oral placebo tablet (2.5 mg), matched in appearance to empagliflozin, administered daily.

Automated Insulin Delivery (AID) System: Continuous use of the participant's personal commercial AID system.

Primary outcome measure

  • Time-in-Range [ Time Frame: At days 7, 35, 63 of the titration period and days 3 and 7 of each intervention. ]

Central Contacts and Locations

Central contacts

Keddy Moise, BScHS

438-531-6896keddy.moise@affiliate.mcgill.ca

Dr. Ahmad Haidar

514-398-4491ahmad.haidar@mcgill.ca

Locations

Research Institute of the McGill University Health Centre

Recruiting

Montréal, Quebec, Canada, H4A 3J1

Contacts

Keddy Moise, BScHS

438-531-6896keddy.moise@affiliate.mcgill.ca

Dr. Ahmad Haidar, PhD

514-398-4491ahmad.haidar@mcgill.ca

Principal Investigator:

Dr. Michael Tsoukas, MD, FRCPC

More Information

Sponsor

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

Last update posted

Mar 30, 2025

Last verified

Mar, 2025

Keywords

  • T1D
  • Combination Therapy
  • Automated Insulin Delivery
  • SGLT2-i
  • GLP1-RA
  • Insulin
  • Artificial Pancreas
  • GLP-1 receptor agonist
  • Diabetes Mellitus, Type 1

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 2025-03-30.