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. (SEVERAL)

February 27, 2024 updated by: Jose Seijas Amigo

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • A Coruña, Spain
        • Centro de Salud de O Ventorrillo
      • Lugo, Spain
        • Centro de Salud de San Roque
      • Pontevedra, Spain
        • Centro de Salud Virxe Peregrina
    • A Coruña
      • Culleredo, A Coruña, Spain
        • Centro de Salud de Culleredo
      • Fene, A Coruña, Spain
        • Centro de Salud de Fene
      • Ribeira, A Coruña, Spain
        • Centro de Salud de Ribeira
      • Santiago De Compostela, A Coruña, Spain
        • Hospital Clínico Universitario de Santiago de Compostela
    • Lugo
      • Ribadeo, Lugo, Spain
        • Centro de Salud de Ribadeo
      • Vilalba, Lugo, Spain
        • Centro de Salud de Vilalba
    • Ourense
      • O Carballiño, Ourense, Spain
        • Centro de Salud de O Carballiño
    • Pontevedra
      • Nigrán, Pontevedra, Spain
        • Centro de Salud Valmiñor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Diagnosis of diabetic retinopahty and family history of thyroid cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Patients are included after GLP1 agonists prescription , at the first dispensation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: 11 months
The primary outcome will be by assesment of % weight loss
11 months
Weight loss
Time Frame: 11 months
Assesment the weiht loss by reduction in Kg
11 months
Weight loss
Time Frame: 11 months
Assesment of changes in BMI ( weight (Kg) and height (cm) will be combined to report BMI in kg/m^2)
11 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c values
Time Frame: 11 months
HbA1c changes will be assessed during the study by routine sample tests (%)
11 months
Changes in Quality of life
Time Frame: 11 months

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/
11 months
Changes in Physical Activity
Time Frame: 11 months
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).
11 months
Number of participants experiencing adverse events
Time Frame: 11 months
Gastrointestinal events; hypoglycemia; pancreatitis; fatigue; ijection reactions; Diabetic retinopathy; cardiac events and other possible events
11 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jose Seijas Amigo

Investigators

  • Study Chair: Jose Seijas Amigo, Hospital Clínico Santiago de Compostela

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

November 15, 2023

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

November 12, 2021

First Submitted That Met QC Criteria

November 26, 2021

First Posted (Actual)

November 29, 2021

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEVERAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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