Study to Explore the Effect of Dapagliflozin and Stress in Adolescent and Adult Subjects With Type 1 Diabetes (T1D)

What Was Tested

The trial (phase 1) is built around Cosyntropin.

Type 1 Diabetes is characterized by an absolute lack of insulin caused by autoimmune ß-cell destruction.

But also euglycemic DKA has been reported during SGLT2 add-on therapy to insulin in T1D and mechanistic studies have been called for.

It had four arms (groups): Dapagliflozin - Stress (experimental), Dapagliflozin and Placebo Stress (experimental), Placebo Dapagliflozin and Stress (placebo comparator) and Placebo Dapagliflozin and Placebo Stress (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

The purpose of the Dapastress trial is, to evaluate if some metabolic parameters can be identified as an early marker or contributor in development of ketonic metabolic imbalance.

As the hormonal "background" is completely different in pubertal adolescents compared to adults (especially contra-insulin hormones as growth hormone, glucagon).

Approximately 20 subjects 18-45 years will be screened in order to randomize 16 patients, where stress and Dapagliflozin (or corresponding placebo) will be administered independently.

The trial will consist of 14 visits: a screening visit (Visit 1), 4 overnight visits complexes (Visit 2 to Visit 13), including phone visits and a follow-up visit (Visit 14).

Who Took Part

The registry lists 2 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: Provision of informed consent from participant and all legal representatives prior to any study specific procedures. Age: Female and/or male aged \>18 years. Subject must have type 1 diabetes (as diagnosed clinically) ≥ 12 months. BMI 23.0 to 35.0 kg/m2 minimum weight of 50 kg. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study as judged by the investigator.

The full record lists 9 inclusion and 19 exclusion criteria; among the exclusions: target disease exclusions; history of t2dm (type 2 diabetes mellitus), maturity onset diabetes of young (mody), pancreatic surgery or chronic pancreatitis; any use of oral hypoglycemic agents within 2 weeks prior to the screening visit.

How the Study Was Run

The set-up was randomized, crossover and triple-blind.

Random assignment meant chance, not the researchers, decided who got Cosyntropin and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Cosyntropin and the comparison in turn, acting as their own control.

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

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2022-05-18 with completion listed for 2022-08-26.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: time to development of DKA (time frame: 12 hours).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cosyntropin in 2 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cosyntropin compound page, all human trials.