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.

NCT05136287 | Completed FDA Drug

• 1 other identifier: SEVERAL
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 11

Brief 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. 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). 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)

Conditions

Weight Loss; Diabetes Mellitus, Type 2; Quality of Life; Safety Issues

Keywords

semaglutide; GLP1 receptor agonists; diabetes mellitus 2; weight loss; BMI

Outcome Measures

Primary Outcomes (3)

• Weight loss

  The primary outcome will be by assesment of % weight loss

  11 months

• Weight loss

  Assesment the weiht loss by reduction in Kg

  11 months

• Weight loss

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

  11 months

Secondary Outcomes (4)

• HbA1c values

  11 months

• Changes in Quality of life

  11 months

• Changes in Physical Activity

  11 months

• Number of participants experiencing adverse events

  11 months

Study Arms (1)

Diabetes mellitus 2 patients with obesity

Patients that meet criteria to start treatment with GLP-1 receptor agonists (dulaglutide; exenatide; liraglutide; lixisenatide )

Drug: GLP-1 receptor agonist

Interventions

GLP-1 receptor agonist DRUG

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

Diabetes mellitus 2 patients with obesity

Eligibility Criteria

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

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.

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of diabetic retinopahty and family history of thyroid cancer

Sponsors & Collaborators

• Jose Seijas Amigo: lead

Study Sites (11)

Centro de Salud de Culleredo

Culleredo, A Coruña, Spain

Location

Centro de Salud de Fene

Fene, A Coruña, Spain

Location

Centro de Salud de Ribeira

Ribeira, A Coruña, Spain

Location

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Location

Centro de Salud de Ribadeo

Ribadeo, Lugo, Spain

Location

Centro de Salud de Vilalba

Vilalba, Lugo, Spain

Location

Centro de Salud de O Carballiño

O Carballiño, Ourense, Spain

Location

Centro de Salud Valmiñor

Nigrán, Pontevedra, Spain

Location

Centro de Salud de O Ventorrillo

A Coruña, Spain

Location

Centro de Salud de San Roque

Lugo, Spain

Location

Centro de Salud Virxe Peregrina

Pontevedra, Spain

Location

Related Publications (13)

• 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.

  PMID: 23882037 BACKGROUND

• 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.

  PMID: 8366922 BACKGROUND

• 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.

  PMID: 9742976 BACKGROUND

• 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.

  PMID: 20609967 BACKGROUND

• 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.

  PMID: 19545590 BACKGROUND

• 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.

  PMID: 26378978 BACKGROUND

• 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.

  PMID: 27295427 BACKGROUND

• 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.

  PMID: 31189511 BACKGROUND

• 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.

  PMID: 29397376 BACKGROUND

• 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.

  PMID: 28249135 BACKGROUND

• 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.

  PMID: 33567185 BACKGROUND

• 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.

  PMID: 36520578 BACKGROUND

• 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.

  PMID: 41129847 DERIVED

Related Links

• Dulaglutide datasheet
• Tofacitinib datasheet
• Exenatide datasheet
• Liraglutide datasheet
• Lixisenatide datasheet
• Semaglutide datasheet

MeSH Terms

Conditions

Weight Loss; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jose Seijas Amigo

  Hospital Clínico Santiago de Compostela

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 29, 2021
• Study Start: February 1, 2022
• Primary Completion: November 15, 2023
• Study Completion: January 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

ES (11)