SITAgliptin Plus GLARgine to Glycemic Control in the Hospital Setting (SITAGLAR-H)
Status:
Recruiting
Trial end date:
2024-07-01
Target enrollment:
Participant gender:
Summary
In noncritically hospitalized patients, hyperglycemia (defined as blood glucose [BG] levels
>140 mg/dL) is a common, serious, and costly healthcare problem. For another hand, the
treatment of hyperglycemia is associated with decreased mortality and morbidity. Therefore,
clinical guidelines from professional organizations recommend the use of 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 insulin daily injections and is associated
with a significant risk of hypoglycemia (reported in up to 32%). Thus, a simpler 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 single 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 in lower rates of hypoglycemia compared to basal-bolus
insulin regimens.
For the above, the use of 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
the use of a basal-plus regimen alone.
In the present study, the investigators will conduct a prospective randomized clinical trial
(RCT) aimed to compare the DPP-4 inhibitor, sitagliptin, in combination with basal-plus
insulin therapy and basal-plus insulin scheme alone, in non-critical hospitalized patients.
Phase:
Phase 4
Details
Lead Sponsor:
Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social