Using Semaglutide with Dieting to Treat Type 2 Diabetes
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
This study tests if adding a medication called semaglutide to a weight loss diet can help people with type 2 diabetes and obesity manage their blood sugar and weight better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 1 site (Helsinki) |
| Trial ID | NCT04854083 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of semaglutide, a medication, as an adjunct to a dieting program for individuals with type 2 diabetes and obesity. Participants will be randomly assigned to receive either semaglutide or a placebo while both groups follow a similar lifestyle intervention aimed at weight loss. The study aims to understand how this combination affects glucose metabolism and long-term weight management in patients. A control group of healthy individuals will also be included for comparison.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with type 2 diabetes and a BMI of 27 or higher.
Not a fit: Patients who have contraindications to the trial drugs or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved weight management and better glucose control for patients with type 2 diabetes.
How similar studies have performed: Other studies have shown promise in using medications like semaglutide for weight management in diabetes, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Helsinki
- University of Helsinki — Helsinki, Finland (Recruiting)
Study contacts
- Principal investigator: Kirsi Pietiläinen, MD PhD — Helsinki University Central Hospital
- Study coordinator: Kirsi H Pietiläinen, MD PhD
- Email: kirsi.pietilainen@helsinki.fi
- Phone: +358505992295
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.