Empagliflozin add-on therapy to closed-loop insulin delivery in type 1 diabetes: a 2 × 2 factorial randomized crossover trial.
Ahmad Haidar, Leif Erik Lovblom, Nancy Cardinez...
https://pubmed.ncbi.nlm.nih.gov/35551290Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID06894784
Semaglutide and Empagliflozin Combination Therapy Added to Automated Insulin Delivery in Adults with Type 1 Diabetes
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2025-03-30
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
D
Diabetes Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating if the drugs Empagliflozin and Semaglutide, alone or combined, can improve blood sugar control by increasing time-in-range in adults with Type 1 Diabetes who use Automated Insulin Delivery (AID) systems. This study also monitors the safety of these drugs in this setting. It is a randomized, double-blind, placebo-controlled Phase 3 crossover trial designed to compare the effects of these treatments in the same participants. Participants will receive four different treatment combinations through a crossover design: semaglutide injection plus empagliflozin tablet, semaglutide injection plus placebo tablet, placebo injection plus empagliflozin tablet, and placebo injection plus placebo tablet. Semaglutide is given by weekly subcutaneous injection with a 12-week dose escalation period to reach a stable dose. Empagliflozin or its placebo is taken daily by tablet. Washout periods between treatments help avoid carryover effects. During the study, participants will use their personal AID systems continuously while researchers collect continuous glucose monitoring data to measure time-in-range and other blood sugar outcomes. Questionnaires will assess diabetes distress and treatment satisfaction after each intervention period. Safety is closely monitored throughout, including tracking adverse events and providing rescue medications for low blood sugar. The entire participation involves multiple treatment periods with careful monitoring and data collection.
CONDITIONS
Brief Title
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
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 or older
- Clinical diagnosis of Type 1 Diabetes for at least one year
- Use of Automated Insulin Delivery system for at least three months
- Body Mass Index (BMI) of 23 kg/m2 or higher
You will not qualify if you...
- Use of GLP1 receptor agonists within one month before enrollment
- Use of SGLT2 inhibitors within two weeks before enrollment
- Planned or ongoing pregnancy
- Breastfeeding
- Severe hypoglycemic episode within three months before enrollment
- Diabetic ketoacidosis episode within six months before enrollment
- History of acute or chronic pancreatitis or gallbladder disease
- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
- Severe kidney impairment with eGFR less than 30 mL/min/1.73 m2 within four months before enrollment
- Significant diabetic retinopathy or gastroparesis as judged by the investigator
- Bariatric surgery within six months before enrollment
- Serious medical or psychiatric illness interfering with participation
- Inability or unwillingness to follow safe diabetes management practices as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Titration Period
Duration - 12 weeks
Participants receive weekly injections of semaglutide or placebo with dose gradually increased over 12 weeks to reach a stable dose, minimizing side effects.
Weekly visits for dose adjustment and monitoring
Treatment Periods
Duration - Four periods of 4 weeks each
Participants undergo four separate 4-week treatment periods receiving different combinations of semaglutide or placebo injections and empagliflozin or placebo tablets while using their automated insulin delivery system.
1 visit at the start and end of each 4-week intervention period
Washout Periods
Duration - Variable, 1 day to 4 weeks depending on washout type
Washout periods of 2 to 4 weeks between semaglutide/placebo arms and 1 to 7 days between empagliflozin/placebo arms to minimize carryover effects.
No scheduled visits; participants continue usual monitoring
Trial Site Locations
Total: 1 location
1
Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
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Research Team
K
Keddy Moise, BScHS
D
Dr. Ahmad Haidar
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range.
Tadej Battelino, Thomas Danne, Richard M Bergenstal...
https://pubmed.ncbi.nlm.nih.gov/31177185Diabetes distress in adults with type 1 diabetes: Prevalence, incidence and change over time.
Lawrence Fisher, Danielle Hessler, William Polonsky...
https://pubmed.ncbi.nlm.nih.gov/27118163Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo-controlled trial.
Bernard Zinman, Vaishali Bhosekar, Robert Busch...
https://pubmed.ncbi.nlm.nih.gov/30833170Glucagon-like peptide-1 receptor agonist and basal insulin combination treatment for the management of type 2 diabetes: a systematic review and meta-analysis.
Conrad Eng, Caroline K Kramer, Bernard Zinman...
https://pubmed.ncbi.nlm.nih.gov/25220191Liraglutide reverses pronounced insulin-associated weight gain, improves glycaemic control and decreases insulin dose in patients with type 2 diabetes: a 26 week, randomised clinical trial (ELEGANT).
Helena M de Wit, Gerald M M Vervoort, Henry J Jansen...
https://pubmed.ncbi.nlm.nih.gov/24947583A meta-analysis of placebo-controlled clinical trials assessing the efficacy and safety of incretin-based medications in patients with type 2 diabetes.
Walid K H Fakhoury, Corinne Lereun, Donna Wright
https://pubmed.ncbi.nlm.nih.gov/20616619Liraglutide for the treatment of type 2 diabetes mellitus: a meta-analysis of randomized placebo-controlled trials.
Qiang Du, Yan-Jun Wang, Sheng Yang...
https://pubmed.ncbi.nlm.nih.gov/25388240Liraglutide reduces hyperglycaemia and body weight in overweight, dysregulated insulin-pump-treated patients with type 1 diabetes: The Lira Pump trial-a randomized, double-blinded, placebo-controlled trial.
Thomas F Dejgaard, Signe Schmidt, Christian S Frandsen...
https://pubmed.ncbi.nlm.nih.gov/31696598Efficacy and Safety of Liraglutide Added to Capped Insulin Treatment in Subjects With Type 1 Diabetes: The ADJUNCT TWO Randomized Trial.
Bo Ahrén, Irl B Hirsch, Thomas R Pieber...
https://pubmed.ncbi.nlm.nih.gov/27493132