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

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 4

Locations

Mexico

Study Type

Interventional

Intervention

Sitagliptin 100mg

Glargine

Lispro

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males or female medical non-ICU patients aged between18 - 70 years.
A known history of type 2 diabetes > 3 months, receiving either diet alone, oral antidiabetic agents (excluding DPP4 inhibitors) low-dose (≤ 0.5 units/kg/day) insulin therapy.
Subjects with BG >180 mg and < 400 mg/dL at the time of randomization without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones).
Written informed consent.

Exclusion Criteria:

Age < 18 or > 70 years.
Subjects with increased BG concentration, but without a history of diabetes (stress hyperglycemia).
Subjects with a history of type 1 diabetes.
Patients with a history of diabetic ketoacidosis or hyperosmolar state.
Acute critical illness or coronary artery bypass graft (CABG) surgery is expected to require admission to a critical care unit.
Subjects with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction.
Unable to take oral food or medications.
Patients with clinically relevant pancreatic or gallbladder disease.
Patients with significant hepatic disease (Child-Pugh score B or C) or impaired renal function (GFR < 50 ml/min).
Treatment with oral or injectable corticosteroid.
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Female subjects are pregnant or breast feeding at time of enrollment into the study.
Hypersensitivity to sitagliptin or another contraindication to DPP4 inhibitors.
Subject unable to give informed consent.

Sites / Locations

División de Investigación en Salud, Hospital de Especialidades, Centro Médico Nacional "La Raza", IMSS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sitagliptin + glargine

Basal-plus

Arm Description

Sitagliptin and glargine once daily + correction doses of lispro if needed.

Glargine once daily plus correction doses of lispro if needed.

Outcomes

Primary Outcome Measures

Change of the mean daily blood glucose levels during hospital

Change of the mean daily blood glucose during the hospitalization between the groups

Secondary Outcome Measures

Percentage of blood glucose readings in 100-180 mg/dL range

Percentage of BG readings in the desired range of 100-180 mg/dl out of all avaialble BG readings.

Dose of Insulin

Average daily amount of insulin used.

Incidence of hypoglycemia (BG <70 mg/dL)

Number of BG readings <70 mg/dL in each group.

Percentage of blood glucose reading >180 mg/dL

Percentage of BG reading >180 mg/dL

Mean length of stay in days in the hospital among different groups

The duration of stay in days in the hospital between the two groups is calculated and mean number of days is measured.

Full Information

NCT ID

NCT05579119

First Posted

July 6, 2022

Last Updated

September 24, 2023

Sponsor

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

Collaborators

National Polytechnic Institute, Mexico

1. Study Identification

Unique Protocol Identification Number

NCT05579119

Brief Title

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

Acronym

SITAGLAR-H

Official Title

Efficacy and Safety of Sitagliptin and Glargine Compared to a Basal-plus Insulin Regimen in Hospitalized Patients With Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

July 6, 2022 (Actual)

Primary Completion Date

August 14, 2023 (Actual)

Study Completion Date

August 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

Collaborators

National Polytechnic Institute, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

Detailed Description

Patients with a known history of diabetes will be randomized to receive sitagliptin plus basal (glargine) insulin or a basal-plus regimen with glargine. Both groups will receive correction doses of rapid-acting insulin lispro in the presence of hyperglycemia (BG >180 mg/dL) per sliding scale. The overall hypothesis is that treatment with sitagliptin in combination with basal insulin will result in better glycemic control and a lower frequency of hypoglycemic events than treatment with a basal-plus insulin regimen in patients with type 2 diabetes in the hospital setting. 68 subjects with type 2 diabetes will be recruited for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sitagliptin + glargine

Arm Type

Experimental

Arm Description

Sitagliptin and glargine once daily + correction doses of lispro if needed.

Arm Title

Basal-plus

Arm Type

Active Comparator

Arm Description

Glargine once daily plus correction doses of lispro if needed.

Intervention Type

Drug

Intervention Name(s)

Sitagliptin 100mg

Other Intervention Name(s)

Januvia

Intervention Description

Sitagliptin 100 mg po once daily.

Intervention Type

Drug

Intervention Name(s)

Glargine

Other Intervention Name(s)

Lantus

Intervention Description

Glargine once daily.

Intervention Type

Drug

Intervention Name(s)

Lispro

Other Intervention Name(s)

Humalog

Intervention Description

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

Primary Outcome Measure Information:

Title

Change of the mean daily blood glucose levels during hospital

Description

Change of the mean daily blood glucose during the hospitalization between the groups

Time Frame

During hospitalization

Secondary Outcome Measure Information:

Title

Percentage of blood glucose readings in 100-180 mg/dL range

Description

Percentage of BG readings in the desired range of 100-180 mg/dl out of all avaialble BG readings.

Time Frame