Effect of Early Combination Antihyperglycemic Treatment With Metformin and Oral Semaglutide vs. Metformin and Empagliflozin on Glycemic and Metabolic Control in Individuals With Short Duration Type 2 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The goal of this clinical trial is to learn if early combination with two antidiabetic drugs further improves blood glucose control compared to a single drug regimen in adults with short duration of type 2 diabetes. It will also learn about the effect of the combination treatment on body weight, body composition, blood lipids, oxidative stress, inflammation, metabolic control, insulin resistance and insulin secretion from pancreas, together with its safety profile. The main questions it aims to answer are: * Does early combination with two antidiabetic drugs improve blood glucose levels, determined by continuous glucose monitoring system? * Is early combination treatment as safe as treatment with a single antidiabetic drug? * Does early combination treatment reduces the need for rescue therapy? * Does early combination treatment reduces body weight and improves body composition? * Does early combination treatment improves blood lipid parameters, oxidative stress and inflammation? * Does early combination treatment improves metabolic parameters? * Does early combination treatment improves insulin resistance and insulin secretion? Researchers will compare early combination treatment with metformin and either peroral semaglutide or empagliflozin to a single drug regimen with only metformin to see if the combination treatment works to treat type 2 diabetes. Participants will: * Take the combination of two antidiabetic drugs or only metformin for every day for 26 weeks. * Visit the clinic four times during the study duration for checkups and tests. * Carry a continuous glucose monitoring sensor for 14 days prior to study visits.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Diagnosed with type 2 diabetes for up to 2 years (prior to randomization);

• Aged between 18 and 70 years, both sexes, of any race or ethnicity;

• HbA1c ≤8.0% at randomization;

• Baseline treatment with metformin at a steady daily dose of ≥1500 mg;

• Signed informed consent to participate in the study.

Locations
Other Locations
Slovenia
University Medical Centre Ljubljana, Diabetes Outpatient Clinic
RECRUITING
Ljubljana
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2027-12
Participants
Target number of participants: 90
Treatments
Active_comparator: Oral Semaglutide Arm
Participants will receive oral semaglutide in addition to metformin (in a steady daily dose of ≥1500 mg), starting with an initial dose of 3 mg. The dose of semaglutide will be increased to 7 mg after 30 days, and then to a maintenance dose of 14 mg once daily after another 30 days that will be continued to week 26. In the case of inadequately controlled glycemia (HbA1c \>8.0 % or symptomatic hyperglycemia), rescue treatment with gliclazide will be initiated.
Active_comparator: Empagliflozin Arm
Participants will receive oral empagliflozin in a once daily dose of 10 mg in addition to metformin (in a steady daily dose of ≥1500 mg). The dose of empagliflozin will not be subsequently changed during the duration of the study. In the case of inadequately controlled glycemia (HbA1c \>8.0 % or symptomatic hyperglycemia), rescue treatment with gliclazide will be initiated.
No_intervention: Control Arm
Participants will receive metformin in a steady daily dose of ≥1500 mg. In the case of inadequately controlled glycemia (HbA1c \>8.0 % or symptomatic hyperglycemia), rescue treatment with gliclazide will be initiated.
Related Therapeutic Areas
Sponsors
Leads: University Medical Centre Ljubljana

This content was sourced from clinicaltrials.gov