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Effect of Early Combination Antihyperglycemic Treatment on Metabolic Control in Individuals With Type 2 Diabetes

NCT06613854 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-04-30

No results posted yet for this study

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.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

DRUG

Oral semaglutide

Semaglutide Oral Tablets will be introduced to the Oral Semaglutide Arm as per protocol for regular therapy introduction.

DRUG

Empagliflozin 10 mg

Empagliflozin Oral Tablets will be introduced to the Empagliflozin Arm as per protocol for regular therapy introduction.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2027-09-30
Completion
2027-12-31

Countries

  • Slovenia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06613854 on ClinicalTrials.gov