SITAgliptin Plus GLARgine to Glycemic Control in the Hospital Setting (SITAGLAR-H)

What Was Tested

The trial (phase 4) is built around Insulin Glargine and Insulin Lispro.

It had two arms (groups): Sitagliptin + glargine (experimental) and Basal-plus (active comparator).

The registry classes the interventions as drug.

More on the Plan

Patients with a known history of diabetes will be randomized to receive sitagliptin plus basal (glargine) insulin or a basal-plus regimen with glargine.

Who Took Part

The registry lists 76 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Males or female medical non-ICU patients aged 18 - 70 years. Written informed consent.

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: age \< 18 or \> 70 years; subjects with a history of type 1 diabetes; patients with a history of diabetic ketoacidosis or hyperosmolar state.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

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

It started in 2022-07-06 with completion listed for 2023-08-14.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Lispro in 76 people.

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

More context: the Insulin Glargine compound page and the Insulin Lispro compound page, all human trials.