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Trial · Interventional

RecruitingPhase 3Registry data

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

Short name SEMPA

NCTNCT06894784 (opens ClinicalTrials.gov in a new tab)Other id2025-10723Other id2025
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
36 participants (estimated)
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre · Other
Design
Randomized · Double masking
Countries
1 country

Canada

Start
Apr 2025 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
First posted
25 Mar 2025
Last update posted
30 Mar 2025
Conditions
Diabetes Type 1

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2025202620272028
  1. Ph 3

    SEMPA

    NCT06894784

    est. Apr 2025 to est. Jan 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Intervention Period 1: Semaglutide + EmpagliflozinDrug
  • Intervention Period 2: Semaglutide + Empagliflozin PlaceboDrug
  • Intervention Period 3: Semaglutide Placebo + EmpagliflozinDrug
  • Intervention Period 4: Semaglutide Placebo + Empagliflozin PlaceboDrug

Arms2

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time-in-Range

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

    Registry description

    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.

Secondary outcomes(12)

  1. Overall Time In Range

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

    Registry description

    Percentage of time (%) spent in ranges of glucose levels : between 3.9 to 10 mmol/L Nota Bene: Secondary endpoints will be computed for (i) semaglutide and empagliflozin versus placebo, (ii) semaglutide and empagliflozin versus empagliflozin alone, (iii) semaglutide and empagliflozin versus semaglutide alone.

  2. Optimal Time In Range

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

    Registry description

    Percentage of time (%) spent in ranges of glucose levels : between 3.9 to 7.8 mmol/L Nota Bene: Secondary endpoints will be computed for (i) semaglutide and empagliflozin versus placebo, (ii) semaglutide and empagliflozin versus empagliflozin alone, (iii) semaglutide and empagliflozin versus semaglutide alone.

  3. Time In Hypoglycemia

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

    Registry description

    Percentage of time (%) spent in ranges of glucose levels : below 3.9 and 3.0 mmol/L Nota Bene: Secondary endpoints will be computed for (i) semaglutide and empagliflozin versus placebo, (ii) semaglutide and empagliflozin versus empagliflozin alone, (iii) semaglutide and empagliflozin versus semaglutide alone.

  4. Time In Mild Hyperglycemia

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

    Registry description

    Percentage of time (%) spent in ranges of glucose levels : above 7.8 mmol/L Nota Bene: Secondary endpoints will be computed for (i) semaglutide and empagliflozin versus placebo, (ii) semaglutide and empagliflozin versus empagliflozin alone, (iii) semaglutide and empagliflozin versus semaglutide alone.

  5. Time Above Range

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

    Registry description

    Percentage of time (%) spent in ranges of glucose levels : above 10 mmol/L Nota Bene: Secondary endpoints will be computed for (i) semaglutide and empagliflozin versus placebo, (ii) semaglutide and empagliflozin versus empagliflozin alone, (iii) semaglutide and empagliflozin versus semaglutide alone.

  6. Time In Severe Hyperglycemia

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

    Registry description

    Percentage of time (%) spent in ranges of glucose levels : above 13.9 mmol/L Nota Bene: Secondary endpoints will be computed for (i) semaglutide and empagliflozin versus placebo, (ii) semaglutide and empagliflozin versus empagliflozin alone, (iii) semaglutide and empagliflozin versus semaglutide alone.

  7. Total Insulin dose

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

    Registry description

    Total daily insulin dose (U/l) Nota Bene: Secondary endpoints will be computed for (i) semaglutide and empagliflozin versus placebo, (ii) semaglutide and empagliflozin versus empagliflozin alone, (iii) semaglutide and empagliflozin versus semaglutide alone.

  8. Basal insulin dose

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

    Registry description

    Total daily basal dose (U/l) Nota Bene: Secondary endpoints will be computed for (i) semaglutide and empagliflozin versus placebo, (ii) semaglutide and empagliflozin versus empagliflozin alone, (iii) semaglutide and empagliflozin versus semaglutide alone.

  9. Bolus insulin dose

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

    Registry description

    Total daily bolus dose (U/l) Nota Bene: Secondary endpoints will be computed for (i) semaglutide and empagliflozin versus placebo, (ii) semaglutide and empagliflozin versus empagliflozin alone, (iii) semaglutide and empagliflozin versus semaglutide alone.

  10. Carbohydrate intake

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

    Registry description

    Average daily meal carbohydrate intake (grams/day) Nota Bene: Secondary endpoints will be computed for (i) semaglutide and empagliflozin versus placebo, (ii) semaglutide and empagliflozin versus empagliflozin alone, (iii) semaglutide and empagliflozin versus semaglutide alone.

  11. Patient-reported outcomes

    Time frame · At the end of each intervention at weeks 16, 21, 29, 34

    Registry description

    Average scores (unit) of the questionnaire : \- Diabetes Distress Scale Nota Bene: Secondary endpoints will be computed for (i) semaglutide and empagliflozin versus placebo, (ii) semaglutide and empagliflozin versus empagliflozin alone, (iii) semaglutide and empagliflozin versus semaglutide alone.

  12. Patient-reported outcomes

    Time frame · At the end of each intervention at weeks 16, 21, 29, 34

    Registry description

    Average scores (unit) of the questionnaire: \- Diabetes Treatment Satisfaction Questionnaire Nota Bene: Secondary endpoints will be computed for (i) semaglutide and empagliflozin versus placebo, (ii) semaglutide and empagliflozin versus empagliflozin alone, (iii) semaglutide and empagliflozin versus semaglutide alone.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies15

Studies that cite this trial.

Studies with results

14 studies on this page

Indexing hint: Randomized controlled trial · 2020

13 results

Efficacy 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 et al. 2020Diabetes & metabolismcited by 308

PMID 31539622DOI 10.1016/j.diabet.2019.101117PUB-31539622

Full text at the publisher13 results
Publisher pageSee results (13)

Indexing hint: Randomized controlled trial · 2020

5 results

Liraglutide 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 et al. 2020Diabetes, obesity & metabolismcited by 58

PMID 31696598DOI 10.1111/dom.13911PUB-31696598

Full text at the publisher5 results
Publisher pageSee results (5)

Indexing hint: Randomized controlled trial · 2020

5 results

Efficacy 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 et al. 2020The lancet. Diabetes & endocrinologycited by 56

PMID 32135138DOI 10.1016/s2213-8587(20)30030-9PUB-32135138

Full text at the publisher5 results
Publisher pageSee results (5)

Indexing hint: Randomized controlled trial · 2019

3 results

Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial.

Gerstein et al. 2019Lancet (London, England)cited by 2,264

PMID 31189511DOI 10.1016/s0140-6736(19)31149-3PUB-31189511

Full text at the publisher3 results
Publisher pageSee results (3)

Indexing hint: Randomized controlled trial · 2018

11 results

Efficacy 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 et al. 2018Diabetes carecited by 481

PMID 29246950DOI 10.2337/dc17-0417PUB-29246950

Full text at the publisher11 results
Publisher pageSee results (11)

Indexing hint: Randomized controlled trial · 2018

21 results

Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial.

Pratley et al. 2018The lancet. Diabetes & endocrinologycited by 614

PMID 29397376DOI 10.1016/s2213-8587(18)30024-xPUB-29397376

Full text at the publisher21 results
Publisher pageSee results (21)

Indexing hint: Randomized controlled trial · 2017

4 results

Liraglutide and Renal Outcomes in Type 2 Diabetes.

Mann et al. 2017The New England journal of medicinecited by 920

PMID 28854085DOI 10.1056/nejmoa1616011PUB-28854085

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Randomized controlled trial · 2016

8 results

Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes.

Marso et al. 2016The New England journal of medicinecited by 5,535

PMID 27295427PMC4985288DOI 10.1056/nejmoa1603827PUB-27295427

Rights unknown8 results
Source linkSee results (8)

Indexing hint: Randomized controlled trial · 2016

10 results

Efficacy and Safety of Liraglutide Added to Capped Insulin Treatment in Subjects With Type 1 Diabetes: The ADJUNCT TWO Randomized Trial.

Ahrén et al. 2016Diabetes carecited by 212

PMID 27493132DOI 10.2337/dc16-0690PUB-27493132

Full text at the publisher10 results
Publisher pageSee results (10)

Indexing hint: Randomized controlled trial · 2016

14 results

Efficacy and Safety of Liraglutide Added to Insulin Treatment in Type 1 Diabetes: The ADJUNCT ONE Treat-To-Target Randomized Trial.

Mathieu et al. 2016Diabetes carecited by 270

PMID 27506222DOI 10.2337/dc16-0691PUB-27506222

Full text at the publisher14 results
Publisher pageSee results (14)

Indexing hint: Randomized controlled trial · 2016

8 results

Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.

Marso et al. 2016The New England journal of medicinecited by 5,002

PMID 27633186DOI 10.1056/nejmoa1607141PUB-27633186

Rights unknown8 results
Source linkSee results (8)

Indexing hint: Randomized controlled trial · 2014

6 results

Liraglutide 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 et al. 2014Diabetologiacited by 57

PMID 24947583DOI 10.1007/s00125-014-3302-0PUB-24947583

Rights unknown6 results
Source linkSee results (6)

Indexing hint: Meta-analysis (pooled) · 2014

5 results

Liraglutide for the treatment of type 2 diabetes mellitus: a meta-analysis of randomized placebo-controlled trials.

Du et al. 2014Advances in therapycited by 19

PMID 25388240DOI 10.1007/s12325-014-0164-2PUB-25388240

Full text at the publisher5 results
Publisher pageSee results (5)

Indexing hint: Meta-analysis (pooled) · 2010

1 result

A meta-analysis of placebo-controlled clinical trials assessing the efficacy and safety of incretin-based medications in patients with type 2 diabetes.

Fakhoury et al. 2010Pharmacologycited by 80

PMID 20616619DOI 10.1159/000314690PUB-20616619

Full text at the publisher1 result
Publisher pageSee results (1)

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2019

Corrected

Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo-controlled trial.

Zinman et al. 2019The lancet. Diabetes & endocrinologycited by 286

PMID 30833170DOI 10.1016/s2213-8587(19)30066-xPUB-30833170

Full text at the publisher
Publisher pageRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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