NCT05579119: SITAGLAR-H

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

Completed Phase 4 Last updated 26 September 2023

What this trial tests

Phase 4 trial testing Sitagliptin 100mg in Type 2 Diabetes in 76 participants. Completed in 24 August 2023.

Timeline

6 July 2022

Primary endpoint
14 August 2023

24 August 2023

Quick facts

Lead sponsor	Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	76
Start date	6 July 2022
Primary completion	14 August 2023
Estimated completion	24 August 2023
Sites	1 location across Mexico

Drugs / interventions tested

• Sitagliptin 100mg — full drug profile →
• Glargine — full drug profile →
• Lispro — full drug profile →

Conditions studied

• Type 2 Diabetes — all drugs for Type 2 Diabetes →

Sponsor

Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social

Who can join

Adults 18 to 70, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In noncritically hospitalized patients, hyperglycemia (defined as blood glucose \[BG\] levels \>140 mg/dL) is a common, serious, and costly healthcare problem. On the other hand, the treatment of hyperglycemia is associated with decreased mortality and morbidity. Therefore, clinical guidelines from professional organizations recommend using subcutaneous insulin as the preferred therapy in hospitalized patients in a non-intensive care unit setting (target glucose range 100 - 180 mg/dl). The most recommended regimen is basal-bolus insulin therapy, although this regimen requires multiple daily insulin injections and is associated with a significant risk of hypoglycemia (reported in up to 32%). Thus, a more straightforward regimen that results in similar glycemic efficacy to basal-bolus insulin with less risk of hypoglycemia could improve care for this group of patients.

The basal-plus insulin regimen consists of a daily dose of basal insulin with supplemental (corrective) doses of rapid-acting insulin analogue before meals. This has similar efficacy and safety as the basal-bolus regimen. However, the basal-plus scheme does not provide prandial coverage of insulin.

In another vein, dipeptidyl peptidase-4 (DPP-4) inhibitors are a class of oral glucose-lowering agents that reduce the breakdown of endogenous glucagon-like peptide-1 (GLP-1), stimulating insulin secretion in a glucose-dependent manner. Some clinical trials have demonstrated that DPP-4 inhibitors, in combination with insulin, result in similar improvement in glycemic control and lower rates of hypoglycemia compared to basal-bolus insulin regimens.

For the above, using a long-acting insulin analogue with a DPP-4 inhibitor could provide better glycemic control basal and prandial, and this scheme could represent an alternative to using a basal-plus regimen alone.

In the present study, the investigators will conduct a prospective randomized clinical trial (RCT) to compare the DPP-4 inhibitor, sitagliptin, combined with basal-plus insulin therapy and basal-plus insulin scheme alone in non-critical hospitalized patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy and safety of sitagliptin with basal-plus insulin regimen versus insulin alone in non-critically ill hospitalized patients with type 2 diabetes: SITA-PLUS hospital trial.
   Gracia-Ramos AE, Cruz-Dominguez MDP, Madrigal-Santillán EO, Rojas-Martínez R, et al · · 2024 · cited 1× · PMID 38581842 · DOI 10.1016/j.jdiacomp.2024.108742