Status:
UNKNOWN
Semaglutide as an Adjunct to Dieting in the Treatment of Type 2 Diabetes
Lead Sponsor:
Kirsi Pietiläinen
Collaborating Sponsors:
University of Helsinki
Turku University Hospital
Conditions:
Type2 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
In this randomized, double-blind, parallel, placebo-controlled trial we compare the effects of semaglutide 1.34 mg/ml vs. normal dieting by randomizing the patients with both T2DM and overweight/obesi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04854083
Start Date
February 17 2022
End Date
August 1 2025
Last Update
March 31 2022
Active Locations (1)
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1
University of Helsinki
Helsinki, Finland