Clinical trial NCT05136287: 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.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Loss
Diabetes Mellitus, Type 2
Quality of Life
Safety Issues
Keywords: semaglutide
GLP1 receptor agonists
diabetes mellitus 2
weight loss
BMI
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
First posted: 2021-11-29
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)


Eligibility criteria: 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

Primary outcomes:
measure: Weight loss
timeFrame: 11 months
measure: Weight loss
timeFrame: 11 months
measure: Weight loss
timeFrame: 11 months
Secondary outcomes:
measure: HbA1c values
timeFrame: 11 months
measure: Changes in Quality of life
timeFrame: 11 months
measure: Changes in Physical Activity
timeFrame: 11 months
measure: Number of participants experiencing adverse events
timeFrame: 11 months
Other outcomes:
Locations:
city: Culleredo
country: Spain
facility: Centro de Salud de Culleredo
state: A Coruña
city: Fene
country: Spain
facility: Centro de Salud de Fene
state: A Coruña
city: Ribeira
country: Spain
facility: Centro de Salud de Ribeira
state: A Coruña
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
state: A Coruña
city: Ribadeo
country: Spain
facility: Centro de Salud de Ribadeo
state: Lugo
city: Vilalba
country: Spain
facility: Centro de Salud de Vilalba
state: Lugo
city: O Carballiño
country: Spain
facility: Centro de Salud de O Carballiño
state: Ourense
city: Nigrán
country: Spain
facility: Centro de Salud Valmiñor
state: Pontevedra
city: A Coruña
country: Spain
facility: Centro de Salud de O Ventorrillo
city: Lugo
country: Spain
facility: Centro de Salud de San Roque
city: Pontevedra
country: Spain
facility: Centro de Salud Virxe Peregrina
Study officials:
affiliation: Hospital Clínico Santiago de Compostela
name: Jose Seijas Amigo
role: STUDY_CHAIR
References:
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citation: 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.
citation: 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.