Sitagliptin Therapy in Hospitalized Patients With Type 2 Diabetes



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:August 2013
End Date:April 2016

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Randomized Controlled Trial on the Safety and Efficacy of Sitagliptin Therapy for the Inpatient Management of General Medicine and Surgery Patients With Type 2 Diabetes

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

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.

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.
We found this trial at
5
sites
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, GA
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
(404) 616-1000
Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
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Atlanta, GA
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Temple University Temple University is many things to many people. A place to pursue life's...
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Philadelphia, PA
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