DPP4 Inhibitor in the Hospital
Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus; Hospitalization; Hyperglycemia
Intervention: Sitagliptin (Drug); glargine (Drug); lispro (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Emory University Official(s) and/or principal investigator(s): Guillermo Umpierrez, MD, Principal Investigator, Affiliation: Emory University SOM
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, but has not been
tested in the hospital. It is not known if sitagliptin is as effective in controlling blood
sugars in the hospital. This study will compare sitagliptin by mouth, insulin (glargine)
injection, and the combination of sitagliptin and lantus insulin in controlling blood sugar
in hospitalized patients with diabetes.
In this pilot study, patients with known history of diabetes treated with diet and/or OAD or
with low total daily dose insulin therapy (<0. 4 unit/kg/day) will be randomized to receive
sitagliptin once daily (group 1), sitagliptin plus basal (glargine) insulin once daily
(group 2), or basal bolus regimen with glargine once daily and lispro insulin before meals
(group 3). If needed, patients in the 3 treatment groups will receive correction doses of
rapid-acting lispro (Humalog®) insulin in the presence of hyperglycemia (BG > 140 mg/dl) per
sliding scale. The overall hypothesis is that treatment with sitagliptin once daily alone
or in combination with basal insulin in patients with type 2 diabetes will result in a
similar improvement in 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.
A total of 90 subjects with type 2 diabetes will be recruited in this study. Patients will
be recruited at Grady Memorial Hospital and Emory University Hospital.
Clinical Details
Official title: Randomized Controlled Study of DPP4 Inhibitor (Sitagliptin) Therapy in the Inpatient Management of Patients With Type 2 Diabetes
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Glucose Levels
Secondary outcome: HypoglycemiaSevere Hypoglycemia Hyperglycemia Total Daily Dose of Insulin ICU Need Composite Cardiac Complications Acute Renal Failure Hospital Mortality
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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 T2DM > 3 months, receiving either diet alone, oral antidiabetic
agents: sulfonylureas and metformin as monotherapy or in combination therapy
(excluding 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 mEq/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 CABG surgery expected to require prolonged admission to a
critical care unit (ICU, CCU, SICU, 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 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.
Locations and Contacts
Emory University Hospital, Atlanta, Georgia 30324, United States
Grady Memorial Hospital, Atlanta, Georgia 30303, United States
Additional Information
Starting date: August 2011
Last updated: June 7, 2014
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