Overview

Sitagliptin Therapy in Hospitalized Patients With Type 2 Diabetes

Status:
Completed
Trial end date:
2016-04-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Emory University
Collaborators:
Merck Sharp & Dohme Corp.
Ohio University
Temple University
University of Michigan
Treatments:
Insulin
Insulin Glargine
Insulin Lispro
Insulin, Globin Zinc
Insulin, Short-Acting
Metformin
Sitagliptin Phosphate
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.