Semaglutide as an Adjunct to Dieting in the Treatment of Type 2 Diabetes

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The pharmacological approaches in the treatment of type 2 diabetes (T2DM) have advanced radically during the last decades. However, focus on long-term management of body weight, which is an essential part of treatment success, is often lacking. Excluding surgery, there are only a few effective treatment methods for obesity. Management of obesity is also greatly challenged by weight regain, which is common after a successful lifestyle intervention. Weight regain typically results in the deterioration of glucose homeostasis in T2DM. However, understanding the pathomechanisms of weight regain and subsequent worsening of glucose homeostasis is still insufficient. Therefore, T2DM treatment programs that target long-term weight management have been scarce. This study aims to fill the gaps in the current knowledge by advancing the development of treatment programs for T2DM that simultaneously head for improved glucose metabolism and improved long-term body weight control.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kirsi Pietiläinen
• Collaborators: Turku University Hospital; University of Helsinki

Criteria

Inclusion Criteria:

• Age ≥18 years and <65 years

• BMI: ≥27 kg/m2

• T2DM (HbA1c ≥ 6.0% if on anti-diabetic medication or HbA1c≥6.5% if non- medicated)

• Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria:

• 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 (GFR<30 ml/min/1.73m2)

• Impaired hepatic function (ALAT>2 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