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

Phase 1

• Conditions: Type 2 diabetes; MedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2020-002712-51-FI
• Lead Sponsor: Kirsi Pietiläinen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-23
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Inclusion criteria for the group of type 2 diabetes
- Age =18 years and <65 years
- BMI: =27 kg/m2
- T2DM (HbA1c = 6% 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

Inclusion criteria for the control group
- Age =18 years and <65 years
- BMI <25 kg/m2
- participants willing and able to give informed consent for participation in the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 (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

Exclusion criteria for the control group
- T2DM
- All others as above for the main study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified