SITAgliptin Plus GLARgine to Glycemic Control in the Hospital Setting (SITAGLAR-H)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Sitagliptin 100mg; Glargine; Lispro
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sitagliptin 100 mg po once daily.; Glargine once daily.; Correctional doses of lispro if needed for elevated blood glucose using sliding scale insulin (SSI).
Other intervention name(s): Januvia; Lantus; Humalog
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment