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

September 24, 2023 updated by: Abraham Edgar Gracia-Ramos, Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 02990
        • División de Investigación en Salud, Hospital de Especialidades, Centro Médico Nacional "La Raza", IMSS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Males or female medical non-ICU patients aged 18 - 70 years.
  2. A known history of type 2 diabetes > 3 months, receiving either diet alone, oral antidiabetic agents (excluding DPP4 inhibitors), or low-dose (≤ 0.5 units/kg/day) insulin therapy.
  3. 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).
  4. Written informed consent.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sitagliptin + glargine
Sitagliptin and glargine once daily + correction doses of lispro if needed.
Drug: Sitagliptin 100mg
Sitagliptin 100 mg po once daily.
Other Names:
  • Januvia
Drug: Glargine
Glargine once daily.
Other Names:
  • Lantus
Drug: Lispro
Correctional doses of lispro if needed for elevated blood glucose using sliding scale insulin (SSI).
Other Names:
  • Humalog
Active Comparator: Basal-plus
Glargine once daily plus correction doses of lispro if needed.
Drug: Glargine
Glargine once daily.
Other Names:
  • Lantus
Drug: Lispro
Correctional doses of lispro if needed for elevated blood glucose using sliding scale insulin (SSI).
Other Names:
  • Humalog

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the mean daily blood glucose levels during hospital
Time Frame: During hospitalization
Change of the mean daily blood glucose during the hospitalization between the groups
During hospitalization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of blood glucose readings in 100-180 mg/dL range
Time Frame: During hospitalization, up to 10 days
Percentage of BG readings in the desired range of 100-180 mg/dl out of all avaialble BG readings.
During hospitalization, up to 10 days
Dose of Insulin
Time Frame: During hospitalization, up to 10 days
Average daily amount of insulin used.
During hospitalization, up to 10 days
Incidence of hypoglycemia (BG <70 mg/dL)
Time Frame: During hospitalization, up to 10 days
Number of BG readings <70 mg/dL in each group.
During hospitalization, up to 10 days
Mean length of stay in days in the hospital among different groups
Time Frame: During hospitalization, up to 10 days
The duration of stay in days in the hospital between the two groups is calculated and mean number of days is measured.
During hospitalization, up to 10 days
Percentage of blood glucose reading >180 mg/dL
Time Frame: During hospitalization, up to 10 days
Percentage of BG reading >180 mg/dL
During hospitalization, up to 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

National Polytechnic Institute, Mexico

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2022

Primary Completion (Actual)

August 14, 2023

Study Completion (Actual)

August 24, 2023

Study Registration Dates

First Submitted

July 6, 2022

First Submitted That Met QC Criteria

October 11, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 24, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2021-3501-078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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