AzTrials
AzTrials

Weight LossSEVERALNCT05136287

SEMAGLUTIDE VERSUS GLP-1 RECEPTOR AGONISTS. EFFECTIVENESS , SAFETY AND QUALITY OF LIFE IN PATIENTS WITH DIABETES MELLITUS 2. OBSERVATIONAL, PROSPECTIVE AND MULTICENTER STUDY. SEVERAL STUDY.

An observational study of Weight Loss and Diabetes Mellitus, Type 2, run by Jose Seijas Amigo at 11 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Introduction: GLP-1 receptor agonists (aGLP1) act increasing pancreatic insulin secretion in response to the glucose, they reduce glucagon secretion and reduce appetite by acting in the central level. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GLP-1 receptor agonist
How many people
140 participants
Where
11 sitesSpain
Study dates
1 Feb 2022to 1 Jan 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with Diabetes mellitus 2 with another oral antidibetic and obesity (BMI > 30Kg/m2) that present uncontrolled HbA1c. With a first prescription of GLP-1 receptor agonists.

Who may be able to join

  • Patients 18 years old or over
  • To start with the first funded dose of GLP1 receptor agonists ( BMI > 30Kg/m2)
  • Treated with another oral antidiabetic

Who cannot join

  • Diagnosis of diabetic retinopahty and family history of thyroid cancer

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Spain11 sites

  • Centro de Salud de O Ventorrillo

    A Coruña

  • Centro de Salud de Culleredo

    Culleredo, A Coruña

  • Centro de Salud de Fene

    Fene, A Coruña

  • Centro de Salud de San Roque

    Lugo

  • Centro de Salud Valmiñor

    Nigrán, Pontevedra

  • Centro de Salud de O Carballiño

    O Carballiño, Ourense

  • Centro de Salud Virxe Peregrina

    Pontevedra

  • Centro de Salud de Ribadeo

    Ribadeo, Lugo

  • Centro de Salud de Ribeira

    Ribeira, A Coruña

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago de Compostela, A Coruña

  • Centro de Salud de Vilalba

    Vilalba, Lugo

Other trials in Spain

About this study

Introduction:

GLP-1 receptor agonists (aGLP1) act increasing pancreatic insulin secretion in response to the glucose, they reduce glucagon secretion and reduce appetite by acting in the central level. Several aGLP1 were approved through different clinical trials where they showed efficacy in the glycemic control and reduction in cardiovascular events. They also showed weight loss in different clinical trials with patients with diabetes mellitus 2 (DM2) and also in specific clinical trial where the weight loss was the primary endpoint (STEP study).

Read more

Objective:

The objective is to evaluate and compare the weight loss in patients with DM2 treated with the different aGLP1 for the first time. Secondary endpoints are HbA1c reduction, changes in quality of life and physical activity and the safety of these drugs.

Design:

It is a postauthorization, multicenter, non-randomized and prospective study. Patients that will start treatment for the first time with aGLP1 will be recruited in 10 primary care centers in SERGAS Galician Hospitals for a period of 6 months and 44 weeks of follow-up. The primary endpoint will be to evaluate the wight loss with the different aGLP1 and the secondary endpoint will be HbA1c reduction, changes in the quality of life through the EuroQol-5D and changes physical activity through the SF-12 questionnaire, and also the safety of these drugs. The sample size will be of 360 patients.

Statistical analysis:

Previous studies showed efficacy in weight loss with semaglutide about (3,6-4,9 kg), while with other aGLP1 the weight loss was smaller , about (0,86-2,96 kg).

Based in these data and with a 5% of significance level, a weight loss average in the aGLP1 group of 2,5 kg, average in semaglutide group of 4,2 kg, and combination deviation of 3,0kg, including 360 subjects we will have a statistical power above 90% to detect differences through T-test for independent samples.

The justification of this simple size was performed with the statistical software SPSS 3.0

Conclusions:

The SEVERAL study will try to provide information about weight loss efficacy, changes in quality of life, physical activity and safety of the aGLP1in patients with DM2 that start treatment with these drugs in the real life (Real-World Evidence)

Being tested
GLP-1 receptor agonist
Keywords
semaglutide, GLP1 receptor agonists, diabetes mellitus 2, weight loss, BMI
Medical subject headings
Weight Loss, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLP-1 receptor agonistDrug

    Patients are included after GLP1 agonists prescription , at the first dispensation

Study groups in NCT05136287
Study groupRoleWhat they receive
Diabetes mellitus 2 patients with obesityPatients that meet criteria to start treatment with GLP-1 receptor agonists (dulaglutide; exenatide; liraglutide; lixisenatide )
Receives: Drug: GLP-1 receptor agonist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight loss

    The primary outcome will be by assesment of % weight loss

    Measured: 11 months

  2. Weight loss

    Assesment the weiht loss by reduction in Kg

    Measured: 11 months

  3. Weight loss

    Assesment of changes in BMI ( weight (Kg) and height (cm) will be combined to report BMI in kg/m^2)

    Measured: 11 months

Secondary outcomes (4)

  1. HbA1c values

    HbA1c changes will be assessed during the study by routine sample tests (%)

    Measured: 11 months

  2. Changes in Quality of life

    By using the questionnaire called EuroQol EQ-5D-3L assessment. It has 2 parts, the first one has 5 questions with 3 possible answers (5 dimensions and 3 levels), so each health status has a rate called EVA from 1,0000 (the highest value) to - 0,5095 (the worst health status).

    The second part is a visual self-assessment between 0 (the worst health status) and 100 (the best health status). https://euroqol.org/

    Measured: 11 months

  3. Changes in Physical Activity

    By using the questionnaire called EuroQol SF-12 assessment.For each of the 8 dimensions, the items are coded, added and transformed on a scale that ranges from 0 (the worst health status for that dimension) to 100 (the best health status).

    Measured: 11 months

  4. Number of participants experiencing adverse events

    Gastrointestinal events; hypoglycemia; pancreatitis; fatigue; ijection reactions; Diabetic retinopathy; cardiac events and other possible events

    Measured: 11 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2021
  2. Study start1 Feb 2022
  3. Primary completion15 Nov 2023
  4. Study completion1 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05136287
Sponsor's protocol ID
SEVERAL
Acronym
SEVERAL
Status last verified
Feb 2024
First submitted
12 Nov 2021
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • DeFronzo RA, Eldor R, Abdul-Ghani M. Pathophysiologic approach to therapy in patients with newly diagnosed type 2 diabetes. Diabetes Care. 2013 Aug;36 Suppl 2(Suppl 2):S127-38. doi: 10.2337/dcS13-2011. No abstract available.

    PubMed 23882037

  • Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.

    PubMed 8366922

  • Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.

    PubMed 9742976

  • Emerging Risk Factors Collaboration; Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, Ingelsson E, Lawlor DA, Selvin E, Stampfer M, Stehouwer CD, Lewington S, Pennells L, Thompson A, Sattar N, White IR, Ray KK, Danesh J. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet. 2010 Jun 26;375(9733):2215-22. doi: 10.1016/S0140-6736(10)60484-9.

    PubMed 20609967

  • Verspohl EJ. Novel therapeutics for type 2 diabetes: incretin hormone mimetics (glucagon-like peptide-1 receptor agonists) and dipeptidyl peptidase-4 inhibitors. Pharmacol Ther. 2009 Oct;124(1):113-38. doi: 10.1016/j.pharmthera.2009.06.002. Epub 2009 Jun 21.

    PubMed 19545590

  • Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.

    PubMed 26378978

  • Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13.

    PubMed 27295427

  • Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riesmeyer JS, Riddle MC, Ryden L, Xavier D, Atisso CM, Dyal L, Hall S, Rao-Melacini P, Wong G, Avezum A, Basile J, Chung N, Conget I, Cushman WC, Franek E, Hancu N, Hanefeld M, Holt S, Jansky P, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Cardona Munoz EG, Pirags V, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T; REWIND Investigators. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019 Jul 13;394(10193):121-130. doi: 10.1016/S0140-6736(19)31149-3. Epub 2019 Jun 9.

    PubMed 31189511

  • Pratley RE, Aroda VR, Lingvay I, Ludemann J, Andreassen C, Navarria A, Viljoen A; SUSTAIN 7 investigators. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018 Apr;6(4):275-286. doi: 10.1016/S2213-8587(18)30024-X. Epub 2018 Feb 1.

    PubMed 29397376

  • Marso SP, Holst AG, Vilsboll T. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2017 Mar 2;376(9):891-2. doi: 10.1056/NEJMc1615712. No abstract available.

    PubMed 28249135

  • Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.

    PubMed 33567185

  • Seijas-Amigo J, Salgado-Barreira A, Castelo-Dominguez R, Pereira-Pia M, Rodriguez-Manero M, Gonzalez-Juanatey JR. Semaglutide versus GLP-1 agonists. Effectiveness, safety, and quality of life in patients with diabetes mellitus 2. The SEVERAL study. Farm Hosp. 2022 Aug 30;46(6):372-379.

    PubMed 36520578

  • Seijas-Amigo J, Salgado-Barreira A, Roca-Martinez C, Castelo-Dominguez R, Perez-Alvarez MT, Ponce-Pinon B, Fernandez-Silva M, Rodriguez-Barreiro M, Pereira-Pia M, Iglesias-Moreno JM, Gago-Garcia M, Montans-Garcia R, Fernandez-Perez A, Fraga-Gayoso D, Fernandez-Montenegro M, Riveiro-Barciela B, Rilla-Villar N, Cardeso-Paredes B, Ribeiro-Ferreiro M, Rodriguez-Penas D, Cordero A, Rodriguez-Manero M, Gonzalez-Juanatey JR; SEVERAL INVESTIGATORS. Real-world Impact of GLP-1 Receptor Agonists on Health-related Quality of Life in Type 2 Diabetes and Obesity (SEVERAL Study). Clin Ther. 2026 Jul;48(7):596-603. doi: 10.1016/j.clinthera.2026.03.012. Epub 2026 May 7.

    PubMed 42103575

  • Seijas-Amigo J, Salgado-Barreira A, Castelo-Dominguez R, Perez-Alvarez MT, Ponce-Pinon B, Fernandez-Silva M, Rodriguez-Barreiro M, Pereira-Pia M, Iglesias-Moreno JM, Gago-Garcia M, Montans-Garcia R, Fernandez-Perez A, Fraga-Gayoso D, Fernandez-Montenegro M, Riveiro-Barciela B, Rilla-Villar N, Cardeso-Paredes B, Ribeiro-Ferreiro M, Rodriguez-Penas D, Cordero A, Rodriguez-Manero M, Gonzalez-Juanatey JR; SEVERAL INVESTIGATORS. Effects of GLP-1 agonists on 10-year cardiovascular risk reduction in primary prevention: A 44-week open label prospective study. Diabetes Metab Syndr. 2025 Sep;19(9):103312. doi: 10.1016/j.dsx.2025.103312. Epub 2025 Oct 19.

    PubMed 41129847

Questions about this trial

What is this clinical trial studying?

An observational study of Weight Loss and Diabetes Mellitus, Type 2, run by Jose Seijas Amigo at 11 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight loss (time frame: 11 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05136287, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in