LivingGLP1
Study S000485

Semaglutide And Empagliflozin Combination Therapy Added To Automated Insulin Delivery In Adults With Type 1 Diabetes (SEMPA)

ClinicalTrials.gov record

Registration

Registration
NCT06894784
Acronym
SEMPA
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
DOUBLE
Status
RECRUITING
Enrollment
36
Start
2025-04
Primary completion
2027-01
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions
Diabetes Type 1
Interventions
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
Results posted
FALSE
Individual participant data sharing
YES
Secondary identifiers
NIH:2025

Registered primary outcomes

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

Linked records (22)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0006810Glucagon-like peptide-1 receptor agonists as adjunctive treatment for type 1 diabetes: Renewed opportunities through tailored approaches?
Kobayati A, Diabetes, obesity & metabolism
2022Randomized trialPMID 34989070DOIregistry reference BACKGROUND:34989070
R0012616Liraglutide 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.
Dejgaard TF, Diabetes, obesity & metabolism
2020Randomized trialPMID 31696598DOIregistry reference BACKGROUND:31696598
R0015226Efficacy and safety of meal-time administration of short-acting exenatide for glycaemic control in type 1 diabetes (MAG1C): a randomised, double-blind, placebo-controlled trial.
Johansen NJ, The lancet. Diabetes & endocrinology
2020Randomized trialPMID 32135138DOIregistry reference BACKGROUND:32135138
R0019465Efficacy and safety of once-weekly semaglutide 1.0mg vs once-daily liraglutide 1.2mg as add-on to 1-3 oral antidiabetic drugs in subjects with type 2 diabetes (SUSTAIN 10).
Capehorn MS, Diabetes & metabolism
2020Randomized trialPMID 31539622DOIregistry reference BACKGROUND:31539622
R0016423GLP-1 Receptor Agonists and Kidney Protection.
Greco EV, Medicina (Kaunas, Lithuania)
2019Randomized trialPMID 31159279DOIregistry reference BACKGROUND:31159279
R0018537Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial.
Gerstein HC, Lancet (London, England)
2019Randomized trialPMID 31189511DOIregistry reference BACKGROUND:31189511
R0020457Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo-controlled trial.
Zinman B, The lancet. Diabetes & endocrinology
2019Randomized trialPMID 30833170DOIregistry reference BACKGROUND:30833170
R0024139Glucagon-like peptide 1 (GLP-1).
Müller TD, Molecular metabolism
2019PreclinicalPMID 31767182DOIregistry reference BACKGROUND:31767182
R0014565Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial.
Pratley RE, The lancet. Diabetes & endocrinology
2018Randomized trialPMID 29397376DOIregistry reference BACKGROUND:29397376
R0020680Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial.
Ahmann AJ, Diabetes care
2018Randomized trialPMID 29246950DOIregistry reference BACKGROUND:29246950
R0021512Liraglutide and Renal Outcomes in Type 2 Diabetes.
Mann JFE, The New England journal of medicine
2017Randomized trialPMID 28854085DOIregistry reference BACKGROUND:28854085
R0022060Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes.
Marso SP, The New England journal of medicine
2016Randomized trialPMID 27295427DOIregistry reference BACKGROUND:27295427
R0022278Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.
Marso SP, The New England journal of medicine
2016Randomized trialPMID 27633186DOIregistry reference BACKGROUND:27633186
R0025363Efficacy and Safety of Liraglutide Added to Insulin Treatment in Type 1 Diabetes: The ADJUNCT ONE Treat-To-Target Randomized Trial.
Mathieu C, Diabetes care
2016Randomized trialPMID 27506222DOIregistry reference BACKGROUND:27506222
R0025614Efficacy and Safety of Liraglutide Added to Capped Insulin Treatment in Subjects With Type 1 Diabetes: The ADJUNCT TWO Randomized Trial.
Ahrén B, Diabetes care
2016Randomized trialPMID 27493132DOIregistry reference BACKGROUND:27493132
R0016924Glucagon-like peptide-1 receptor agonist and basal insulin combination treatment for the management of type 2 diabetes: a systematic review and meta-analysis.
Eng C, Lancet (London, England)
2014Systematic reviewPMID 25220191DOIregistry reference BACKGROUND:25220191
R0025175Liraglutide 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).
de Wit HM, Diabetologia
2014Randomized trialPMID 24947583DOIregistry reference BACKGROUND:24947583
R0026242Liraglutide for the treatment of type 2 diabetes mellitus: a meta-analysis of randomized placebo-controlled trials.
Du Q, Advances in therapy
2014Systematic reviewPMID 25388240DOIregistry reference BACKGROUND:25388240
R0013024Incretin-based therapies.
Stonehouse AH, Journal of diabetes
2012Narrative reviewPMID 21707956DOIregistry reference BACKGROUND:21707956
R0021816A meta-analysis of placebo-controlled clinical trials assessing the efficacy and safety of incretin-based medications in patients with type 2 diabetes.
Fakhoury WK, Pharmacology
2010Systematic reviewPMID 20616619DOIregistry reference BACKGROUND:20616619
R0023918Treatment of type 1 diabetic patients with glucagon-like peptide-1 (GLP-1) and GLP-1R agonists.
Kielgast U, Current diabetes reviews
2009PreclinicalPMID 19925391DOIregistry reference BACKGROUND:19925391
R0028112Glucagon-like peptide 1 (GLP-1) as a new therapeutic approach for type 2-diabetes.
Nauck MA, Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association
1997Narrative reviewPMID 9285204DOIregistry reference BACKGROUND:9285204