Dipeptidyl Peptidase-4 Inhibitor (Sitagliptin) Therapy in the Inpatients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus; Hospitalization; Hyperglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia
Intervention: Sitagliptin; glargine; lispro
Intervention description: Sitagliptin 50-100mg po once daily; glargine once daily; lispro before meals
Intervention MeSH terms: Insulin Glargine; Sitagliptin Phosphate; Insulin Lispro
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: diabetes; non critical care setting; hyperglycemia; treatment; oral antidiabetic agents; subcutaneous insulin

Summary:

      The study is a multicenter, prospective, open-label, randomized pilot study to investigate
      the safety and efficacy of sitagliptin (Januvia) for the inpatient management of type 2
      diabetes (T2D) in general medicine and surgery patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females between the ages of 18 and 80 years admitted to a general medicine
             and surgery services.

          2. A known history of type 2 diabetes mellitus > 3 months, receiving either diet alone,
             oral antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination
             therapy (excluding Trazodone (TZDs) and DPP4 inhibitors), or low-dose (≤ 0.4
             units/kg/day) insulin therapy.

          3. Subjects with a BG >140 mg and < 400 mg/dL without laboratory evidence of diabetic
             ketoacidosis (serum bicarbonate < 18 milliequivalent /L or positive serum or urinary
             ketones).

        Exclusion Criteria:

          1. Age < 18 or > 80 years.

          2. Subjects with increased blood glucose concentration, but without a known history of
             diabetes (stress hyperglycemia).

          3. Subjects with a history of type 1 diabetes (suggested by BMI < 25 requiring insulin
             therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic
             state, or ketonuria) [46].

          4. History of TZD treatment (pioglitazone or rosiglitazone) or DPP4 inhibitor
             (sitagliptin or saxagliptin) during the past 3 months prior to admission.

          5. Acute critical illness or coronary artery bypass graft (CABG) surgery expected to
             require prolonged admission to a critical care unit (ICU, cardiac care unit , surgical
             intensive care unit, neuro ICU).

          6. Subjects with gastrointestinal obstruction or adynamic ileus or those expected to
             require gastrointestinal suction.

          7. Medical or surgical patients expected to be kept nil per os (NPO) for >24-48 hours
             after admission or after completion of surgical procedure.

          8. Patients with clinically relevant pancreatic or gallbladder disease.

          9. Patients with congestive heart failure (NYHA class III and IV), acute myocardial
             infarction, clinically significant hepatic disease or significantly impaired renal
             function (serum creatinine ≥ 2.0 mg/dL).

         10. Treatment with oral or injectable corticosteroid.

         11. Mental condition rendering the subject unable to understand the nature, scope, and
             possible consequences of the study.

         12. Female subjects are pregnant or breast feeding at time of enrollment into the study.