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

NCT05579119 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-09-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Sitagliptin 100mg

Sitagliptin 100 mg po once daily.

DRUG

Glargine

Glargine once daily.

DRUG

Lispro

Correctional doses of lispro if needed for elevated blood glucose using sliding scale insulin (SSI).

Sponsors & Collaborators

  • National Polytechnic Institute, Mexico

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Abraham Edgar Gracia-Ramos, MD, MSc · Hospital General, Centro Médico Nacional "La Raza", IMSS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-06
Primary Completion
2023-08-14
Completion
2023-08-24

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05579119 on ClinicalTrials.gov