Sitagliptin Therapy in Hospitalized Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

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
    

Detailed description: 
      Specific Aim 1: To determine whether in-hospital glycemic control, as measured by mean daily
      blood glucose concentration and frequency of hypoglycemic events, is different between
      treatment with sitagliptin (Januvia®) in combination with basal insulin (glargine) and basal
      bolus regimen (glargine and rapid-acting insulin analog) in general medicine and surgery
      patients with T2D. Patients with T2D treated with diet and/or OAD or with low total daily
      dose insulin therapy (≤0.6 unit/kg/day) will be randomized to receive sitagliptin plus
      glargine insulin (group 1) or basal bolus regimen with glargine once daily and rapid-acting
      insulin (lispro or aspart) before meals (group 2). If needed, patients in the 2 treatment
      groups will receive supplemental (correction) doses of rapid-acting insulin before meals for
      BG > 140 mg/dl.

      Specific Aim 2: To determine the efficacy and safety of an A1C based discharge algorithm in
      controlling BG after discharge in patients with T2D. Patients who participate in the
      in-hospital (Aim 1) arm will be invited to enroll in this open label prospective outpatient
      study. The total duration of the study is 6 months. Patients with HbA1c ≤ 7% will be
      discharged on the combination of metformin and sitagliptin (Janumet ®) twice daily. Those
      with HbA1c between 7% and 9% will be discharged on metformin and sitagliptin (Janumet ®)
      twice daily plus glargine insulin at 50% of the inpatient glargine dose. Those with HbA1c >
      9% will be discharged on metformin and sitagliptin (Janumet ®) twice-daily plus glargine
      insulin at 80% of the inpatient dose.
    

Intervention name(s): Sitagliptin; Basal Bolus; Metformin and Sitagliptin; Glargine; Glargine 50%; Glargine 80%
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Januvia; Glargine (Lantus) + aspart (Novolog) or lispro (Humalog); Janumet; Lantus
Intervention MeSH terms: Metformin; Insulin Glargine; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; DPP4 inhibitors; Sitagliptin; Glargine; RCT; basal insulin; hospital hyperglycemia; inpatient diabetes