Triple Therapy in T1DM

What Was Tested

The trial (phase 2, phase 3) is built around Semaglutide and Insulin (regular human).

It had four arms (groups): Control (active comparator), Dual Therapy (experimental), Triple therapy (experimental) and Triple therapy control (placebo comparator).

Standard of care insulin will be used as an active comparator arm for 1/3 of patients (38 patients) for the entire duration of the study.

The registry classes the interventions as drug.

More on the Plan

This will be a 52 week study for type 1 diabetics looking into the effect of semaglutide and dapagliflozin on HbA1c and glycemic control.

Who Took Part

The registry lists 78 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: C-peptide \<0.23 nM. Regularly measuring blood sugars four or more times daily. Well versed in CHO counting\*. Age 18-70 years. BMI ≥25 kg/m2.

The full record lists 8 inclusion and 32 exclusion criteria; among the exclusions: history of diabetic ketoacidosis (dka) requiring medical intervention (e.g., emergency room visit and/or hospitalization) within 3 month prior to the screening visit; subjects on a commercial weight loss program with ongoing weight loss, or on an intensive exercise program; history of bariatric surgery or lap-band procedure within 12 months prior to screening.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

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

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2019-05-01 with completion listed for 2026-01-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c following dapagliflozin (time frame: 6 months).

It also tracked 22 secondary outcomes, for example Change in HbA1c with triple therapy, Change in HbA1c with semaglutide, Assessment of hyperglycemia level 1, Assessment of hyperglycemia level 2, Assessment of hypoglycemia and Assessment of percent time glucose in range.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Semaglutide and Insulin (regular human) in 78 people.

Its status is active not recruiting; 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.