Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes

What Was Tested

This registered phase 2 trial tested Semaglutide and Insulin (regular human).

Type 1 Diabetes (T1DM) is a disease characterised by immune mediated destruction of the insulin-producing pancreatic beta cells.

Overtime, obvious insulin deficiency develops which requires insulin therapy.

It had three arms (groups): Control group (active comparator), Semaglutide group (active comparator) and Empaglflozin group (active comparator).

Standard treatment group (control) that will be 35 patients who will receive multiply daily injections of insulin (basal/bolus) for 3 months.

The registry classes the interventions as drug.

Who Took Part

The registry lists 114 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients diagnosed with type 1 diabetes for more than 1 year. Age 18-65 years. BMI ≥ 27 kg/m². Inadequately controlled despite treatment with multiple daily injections of insulin for at least 1 year.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: insulin pump treatment; any prior use of glp-1 ras or dipeptidyl peptidase-4 inhibitors, any medication (except insulin) that could interfere with glycemic control or affect a subject's safety; liver disease with raised alanine aminotransferase (ast), aspartate transaminase (alt) or alkaline phosphatase (alp)more than three times the upper normal range.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Semaglutide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

It started in 2025-01-20 with completion listed for 2026-01-20.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The primary outcome of this trial is the change in glycated haemoglobin from baseline after 3 months of treatment (time frame: 3 months).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide and Insulin (regular human) in 114 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page and the Insulin (regular human) compound page, all human trials.