Sitagliptin Therapy in Hospitalized Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin; Basal Bolus; Metformin and Sitagliptin; Glargine; Glargine 50%; Glargine 80%
Intervention description: Sitagliptin will be taken orally at 100 mg or 50 mg once a day per renal function.; Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed; Janumet is a combination of metformin and sitagliptin. Patients with HbA1c ≤ 7% will be discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months.; Patients with blood glucose between 140-200 mg/dL during hospitalization will receive 0.2 units per kg weight per day.
Patients with blood glucose between 201-400 mg/dL during hospitalization will receive 0.25 units per kg weight per day.; Glargine will be prescribed at 50% of daily hospital dose.; Glargine will be prescribed at 80% of daily hospital dose.
Intervention MeSH terms: Metformin; Insulin Glargine; Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 292.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Diabetes; DPP4 inhibitors; Sitagliptin; Glargine; RCT; basal insulin; hospital hyperglycemia; inpatient diabetes

Summary:

      High blood glucose levels in hospitalized patients with diabetes are associated with
      increased risk of medical complications and death. Improved glucose control with insulin
      injections may improve clinical outcome and prevent some of the hospital complications.
      Glargine (Lantus®) insulin injection is the most common treatment of diabetes in the
      hospital. Sitagliptin (Januvia®)is effective in lowering blood glucose. In a recent pilot
      study aiming to determine differences in glycemic control between treatment with sitagliptin
      (Januvia®) alone or in combination with basal insulin and basal bolus regimen in general
      medicine and surgery patients with type 2 diabetes (T2D). The investigators found that
      treatment with sitagliptin alone or in combination with basal insulin resulted in similar
      glycemic control compared to basal bolus regimen.

      The investigators will conduct a prospective RCT aimed to determine the safety and efficacy
      of sitagliptin therapy for in-hospital and post-discharge management of general medicine and
      surgical patients with T2D. A total of 280 patients with known history of diabetes will be
      randomized to receive sitagliptin plus basal (glargine) insulin once daily (group 1), or
      basal bolus regimen with glargine once daily and aspart or lispro insulin before meals (group
      2). If needed, patients in the treatment groups will receive correction doses of rapid-acting
      insulin in the presence of hyperglycemia (BG > 140 mg/dl). The overall hypothesis is that
      treatment with sitagliptin in combination with basal insulin in patients with type 2 diabetes
      will result in a similar improvement in hospital and post-discharge glycemic control and in a
      lower frequency of hypoglycemic events than treatment with basal bolus insulin regimen with
      glargine once daily and lispro insulin before meals.

      Patients will be recruited at Grady Memorial Hospital, Emory University Hospital, University
      of Michigan, Ohio State University and Temple University
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females between the ages of 18 and 80 years admitted to medicine and surgery
             services.

          2. A known history of Type 2 Diabetes > 1 month, receiving either diet alone, oral
             antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination
             therapy (excluding DPP-4 inhibitors) or low-dose (≤ 0.6 units/kg/day) insulin therapy.

          3. Subjects with a blood glucose >140 mg and < 400 mg/dL at time of randomization without
             laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive
             serum or urinary ketones).

        Exclusion Criteria:

          1. Age < 18 or > 80 years.

          2. Subjects with increased BG concentration, but without a 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. Treatment with DPP4 inhibitor or Glucagon like peptide 1 (GLP1) analogs during the
             past 3 months prior to admission.

          5. Acute critical illness or coronary artery bypass graft (CABG) surgery expected to
             require admission to a critical care unit.

          6. Subjects with gastrointestinal obstruction or adynamic ileus or those expected to
             require gastrointestinal suction.

          7. Medical or surgical patients expected to be kept 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 acute myocardial infarction, clinically significant hepatic disease or
             significantly impaired renal function (GFR < 30 ml/min).

         10. Treatment with oral or injectable corticosteroid = or > prednisone 5 mg/per day.

         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.