A Clinical Trial to Evaluate The Effects of Semaglutide and Empagliflozin Combined to Automated Insulin Delivery on Diabetes Control in Adults Living With Type 1 Diabetes

NCT06894784 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 2025-10723
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time-in-Range

  The percentage of time spent in target glucose range (3.9-10.0 mmol/L), between Semaglutide and Empagliflozin versus placebo, added to AID therapy.

  At days 7, 35, 63 of the titration period and days 3 and 7 of each intervention.

Secondary Outcomes (12)

• Overall Time In Range

  At days 7, 35, 63 of the titration period and days 3 and 7 of each intervention.

• Optimal Time In Range

  At days 7, 35, 63 of the titration period and days 3 and 7 of each intervention.

• Time In Hypoglycemia

  At days 7, 35, 63 of the titration period and days 3 and 7 of each intervention.

• Time In Mild Hyperglycemia

  At days 7, 35, 63 of the titration period and days 3 and 7 of each intervention.

• Time Above Range

  At days 7, 35, 63 of the titration period and days 3 and 7 of each intervention.

Study Arms (2)

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

EXPERIMENTAL

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.

Drug: Intervention Period 1: Semaglutide + Empagliflozin; Drug: Intervention Period 2: Semaglutide + Empagliflozin Placebo; Drug: Intervention Period 3: Semaglutide Placebo + Empagliflozin; Drug: Intervention Period 4: Semaglutide Placebo + Empagliflozin Placebo

Placebo + Automated Insulin Delivery system

ACTIVE COMPARATOR

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.

Drug: Intervention Period 1: Semaglutide + Empagliflozin; Drug: Intervention Period 2: Semaglutide + Empagliflozin Placebo; Drug: Intervention Period 3: Semaglutide Placebo + Empagliflozin; Drug: Intervention Period 4: Semaglutide Placebo + Empagliflozin Placebo

Interventions

Intervention Period 1: Semaglutide + Empagliflozin DRUG

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.

Placebo + Automated Insulin Delivery system; Semaglutide, Ozempic® (at maximum tolerated dose) + Automated Insulin Delivery system

Intervention Period 2: Semaglutide + Empagliflozin Placebo DRUG

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.

Placebo + Automated Insulin Delivery system; Semaglutide, Ozempic® (at maximum tolerated dose) + Automated Insulin Delivery system

Intervention Period 3: Semaglutide Placebo + Empagliflozin DRUG

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.

Placebo + Automated Insulin Delivery system; Semaglutide, Ozempic® (at maximum tolerated dose) + Automated Insulin Delivery system

Intervention Period 4: Semaglutide Placebo + Empagliflozin Placebo DRUG

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.

Placebo + Automated Insulin Delivery system; Semaglutide, Ozempic® (at maximum tolerated dose) + Automated Insulin Delivery system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Diabetes Canada: collaborator

Study Sites (1)

Research Institute of the McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

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Related Links

• Sizar O, Podder V, Talati R. Empagliflozin. In: StatPearls. StatPearls Publishing; 2024. Accessed April 15, 2024
• Ozempic® Side Effects \| Ozempic® (semaglutide) injection. Accessed April 15, 2024

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Study Officials

• Dr. Michael Tsoukas

  Division of Endocrinology and Metabolism - McGill University Health Center

  PRINCIPAL INVESTIGATOR

• Dr. Melissa-Rosina Pasqua

  Division of Endocrinology and Metabolism - McGill University Health Center

  STUDY DIRECTOR

• Dr. Vanessa Tardio

  Division of Endocrinology and Metabolism - McGill University Health Center

  STUDY DIRECTOR

• Dr. Ahmad Haidar

  Department of Biomedical Engineering - McGill University

  STUDY DIRECTOR

Central Study Contacts

Keddy Moise, BScHS

CONTACT

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

Dr. Ahmad Haidar

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Principal Investigator

Model Details: 2×2 factorial, randomized, placebo-controlled, double-blind, crossover trial assessing the effects of Semaglutide and Empagliflozin, individually and combined, added to AID therapy.

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 25, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CA (1)