Semaglutide in the treatment of type 2 diabetes – effects on prevention of weight regain and metabolism after diet induced weight loss

Semaglutide as an adjunct to dieting in the treatment of type 2 diabetes – effects on glucose metabolism, prevention of weight regain and peripheral tissue metabolic activation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002712-51-FI

Enrollment

Registered

2020-12-23

Start date

2021-03-05

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes MedDRA version: 21.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Ozempic Pharmaceutical Form: Solution for injection in pre-filled pen Pharmaceutical form of the placebo: Solution for injection in pre-filled pen Route of administration of the placebo: S

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria for the group of type 2 diabetes - Age =18 years and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria for the group of type 2 diabetes -Contraindication to trial drugs - Use of insulin or GLP-1RAs (during the past 3 months) - Use of anti-obesity drugs (during the past 3 months) - Weight change of >5% during the past 3 months - Bariatric surgery or planned bariatric surgery during the trial - History of pancreatitis - Impaired renal function (GFR2 x upper limit normal) - Clinically significant active cardiovascular disease - Clinically significant abnormality in the ECG - Cancer (except basal or squamous cell skin cancers) - Major psychiatric disease (such as severe depression, bipolar disorder, schizophrenia) - Substance abuse - Learning disability - Females of childbearing potential not using adequate contraceptive methods - Pregnancy - Lactation - Any other condition that in the opinion of the investigator could interfere with the conduction of the study or interpretation of the study results Exclusion criteria for the control group - T2DM - All others as above for the main study

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to investigate the effect of semaglutide 1.34mg/ml treatment compared with placebo treatment on glucose homeostasis (HbA1c) in patients with T2DM following diet-induced weight loss intervention at 12 months. ;Secondary Objective: The effects of semaglutide 1.34mg/ml compared with placebo: -on weight maintenance following diet-induced weight loss intervention at 12 months (body weight,adiposity-related measures) -on metabolic parameters (liver fat,blood pressure,lipids) following diet-induced weight loss intervention at 12 months -on appetite and eating habits using questionnaires Control of Eating,Binge Eating Scale,Dutch Eating Behaviour Questionnaire,Questionnaire on Eating and Weight Patterns -on adipose tissue and skeletal muscle metabolism and mitochondrial parameters following diet-induced weight loss intervention at 12 months -n oxygen uptake and perfusion-proxy measures of mitochondrial function-of tissues (subcutaneous and intra-abdominal adipose tissue,brown adipose tissue,skeletal muscle,gut and liver) using a PET and CT scanning before vs. after diet-induced weight loss intervention at 12 months -the differences of the above measures between patients with T2DM and healthy controls at baseline;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: The primary objective of this study is to investigate the effect of semaglutide 1.34mg/ml treatment compared with placebo treatment on glucose homeostasis (HbA1c) in patients with T2DM following diet-induced weight loss intervention at 12 months. ;Secondary Objective: The effects of semaglutide 1.34mg/ml compared with placebo: -on weight maintenance following diet-induced weight loss intervention at 12 months (body weight,adiposity-related measures) -on metabolic parameters (liver fat,blood pressure,lipids) following diet-induced weight loss intervention at 12 months -on appetite and eating habits using questionnaires Control of Eating,Binge Eating Scale,Dutch Eating Behaviour Questionnaire,Questionnaire on Eating and Weight Patterns -on adipose tissue and skeletal muscle metabolism and mitochondrial parameters following diet-induced weight loss intervention at 12 months -n oxygen uptake and perfusion-proxy measures of mitochondrial function-of tissues (subcutaneous and intra-abdominal adipose tissue,brown adipose tissue,skeletal muscle,gut and liver) using a PET and CT scanning before vs. after diet-induced weight loss intervention at 12 months -the differences of the above measures between patients with T2DM and healthy controls at baseline;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): - Change in HbA1c at 6 months - Change in fasting plasma glucose - Change in body weight - Percentage of patients reaching =5%,10% & 15% weight loss - Change in waist circumference - Change in appetite and eating habits - Change in blood pressure - Change in lipids (total cholesterol, LDL, HDL, TAG) - Changes in concomitant antidiabetic medications - Changes in concomitant antihypertensive medications - Changes in concomitant lipid medications - Change in mitochondrial DNA (mtDNA) copy number, RNA expression of mtDNA encoded genes in adipose tissue - Change in the transcriptomics profile of adipose tissue - Change in mitochondrial DNA (mtDNA) copy number, RNA expression of mtDNA encoded genes in skeletal muscle - Change in the transcriptomics profile of skeletal muscle - Change in the oxygen uptake and perfusion in subcutaneous and intra-abdominal adipose tissue, brown adipose tissue, skeletal muscle, gut and liver - Differences in glucose metabolism, body weight, adiposity-related measures, liver fat, eating habits, blood pressure, lipids, adipose tissue and skeletal muscle metabolism and oxygen uptake and perfusion of tissues between patients with T2DM and healthy controls at baseline ;Timepoint(s) of evaluation of this end point: - Change in HbA1c from baseline to 6 months - Other secondary endpoints from baseline to 6 and 12 months, - Change in the oxygen uptake and perfusion in subcutaneous and intra-abdominal adipose tissue, brown adipose tissue, skeletal muscle, gut and liver from baseline to 12 months - Differences in glucose metabolism, body weight, adiposity-related measures, liver fat, eating habits, blood pressure, lipids, adipose tissue and skeletal muscle metabolism and oxygen uptake and perfusion of tissues differ between patients with T2DM and healthy controls at Baseline	—

Measure

Time frame

Secondary end point(s): - Change in HbA1c at 6 months - Change in fasting plasma glucose - Change in body weight - Percentage of patients reaching =5%,10% & 15% weight loss - Change in waist circumference - Change in appetite and eating habits - Change in blood pressure - Change in lipids (total cholesterol, LDL, HDL, TAG) - Changes in concomitant antidiabetic medications - Changes in concomitant antihypertensive medications - Changes in concomitant lipid medications - Change in mitochondrial DNA (mtDNA) copy number, RNA expression of mtDNA encoded genes in adipose tissue - Change in the transcriptomics profile of adipose tissue - Change in mitochondrial DNA (mtDNA) copy number, RNA expression of mtDNA encoded genes in skeletal muscle - Change in the transcriptomics profile of skeletal muscle - Change in the oxygen uptake and perfusion in subcutaneous and intra-abdominal adipose tissue, brown adipose tissue, skeletal muscle, gut and liver - Differences in glucose metabolism, body weight, adiposity-related measures, liver fat, eating habits, blood pressure, lipids, adipose tissue and skeletal muscle metabolism and oxygen uptake and perfusion of tissues between patients with T2DM and healthy controls at baseline ;Timepoint(s) of evaluation of this end point: - Change in HbA1c from baseline to 6 months - Other secondary endpoints from baseline to 6 and 12 months, - Change in the oxygen uptake and perfusion in subcutaneous and intra-abdominal adipose tissue, brown adipose tissue, skeletal muscle, gut and liver from baseline to 12 months - Differences in glucose metabolism, body weight, adiposity-related measures, liver fat, eating habits, blood pressure, lipids, adipose tissue and skeletal muscle metabolism and oxygen uptake and perfusion of tissues differ between patients with T2DM and healthy controls at Baseline

—

Countries

Finland

Contacts

Public ContactLihavuustutkimusyksikkö

Obesity Research Unit / Lihavuustutkimusyksikkö

lihavuustutkimusyksikko@gmail.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026