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.

Completed

• Conditions: Weight Loss; Diabetes Mellitus, Type 2; Quality of Life; Safety Issues
• Interventions: Drug: GLP-1 receptor agonist

• Registration Number: NCT05136287
• Lead Sponsor: Jose Seijas Amigo

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-12
• Study First Submitted QC: 2021-11-26
• Study First Posted: 2021-11-29
• Study Start: 2022-02-01
• Primary Completion: 2023-11-15
• Study Completion: 2024-01-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetes mellitus 2 patients with obesity	GLP-1 receptor agonist	Patients that meet criteria to start treatment with GLP-1 receptor agonists (dulaglutide; exenatide; liraglutide; lixisenatide )

Primary Outcome Measures

Name	Time	Method
Weight loss	11 months	Assesment of changes in BMI ( weight (Kg) and height (cm) will be combined to report BMI in kg/m\^2)

Secondary Outcome Measures

Name	Time	Method
HbA1c values	11 months	HbA1c changes will be assessed during the study by routine sample tests (%)
Number of participants experiencing adverse events	11 months	Gastrointestinal events; hypoglycemia; pancreatitis; fatigue; ijection reactions; Diabetic retinopathy; cardiac events and other possible events
Changes in Quality of life	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/
Changes in Physical Activity	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).

Trial Locations

Locations (11)

Centro de Salud de Culleredo; 🇪🇸 Culleredo, A Coruña, Spain

Centro de Salud de Fene; 🇪🇸 Fene, A Coruña, Spain

Centro de Salud Valmiñor; 🇪🇸 Nigrán, Pontevedra, Spain

Hospital Clínico Universitario de Santiago de Compostela; 🇪🇸 Santiago De Compostela, A Coruña, Spain

Centro de Salud de Vilalba; 🇪🇸 Vilalba, Lugo, Spain

Centro de Salud de Ribeira; 🇪🇸 Ribeira, A Coruña, Spain

Centro de Salud de Ribadeo; 🇪🇸 Ribadeo, Lugo, Spain

Centro de Salud de O Carballiño; 🇪🇸 O Carballiño, Ourense, Spain

Centro de Salud Virxe Peregrina; 🇪🇸 Pontevedra, Spain

Centro de Salud de San Roque; 🇪🇸 Lugo, Spain

Centro de Salud de O Ventorrillo; 🇪🇸 A Coruña, Spain