DPP4 Inhibitor in the Hospital

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01378117
Recruitment Status : Completed
First Posted : June 22, 2011
Results First Posted : June 12, 2014
Last Update Posted : June 12, 2014
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Hospitalization Hyperglycemia Drug: Sitagliptin Drug: glargine Drug: lispro Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study of DPP4 Inhibitor (Sitagliptin) Therapy in the Inpatient Management of Patients With Type 2 Diabetes
Study Start Date : August 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : June 2012

Arm Intervention/treatment
Experimental: Sitagliptin + SSI prn
Sitagliptin once daily plus supplemental doses of lispro if needed.
Drug: Sitagliptin
Sitagliptin 50-100mg po once daily
Other Name: Januvia
Experimental: Sitagliptin and glargine+ SSI
Sitagliptin 50-100mg po once a day and SQ glargine insulin once daily + acqhs correctional doses of lispro if needed for elevated blood glucose
Drug: glargine
glargine once daily
Other Name: Lantus (glargine)
Active Comparator: Glargine and Lispro + SSI
Glargine once daily and lispro before meals + acqhs supplemental insulin lispro as needed for elevated blod glucose
Drug: lispro
lispro before meals
Other Name: Humalog (lispro)

Primary Outcome Measures :
  1. Glucose Levels [ Time Frame: during hospitalization, average 5 days ]
    The primary outcome of the study is to determine differences in glycemic control as measured by mean daily BG concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2DM.

Secondary Outcome Measures :
  1. Hypoglycemia [ Time Frame: during hospitalization, average 5 days ]
    Number of hypoglycemic events (<70 mg/dl)

  2. Severe Hypoglycemia [ Time Frame: during hospitalization, average 5 days ]
    severe hypoglycemic events (<40 mg/dl).

  3. Hyperglycemia [ Time Frame: during hospitalization, average 5 days ]
    Number of episodes of hyperglycemia (BG > 300 mg/dl) after the first day of treatment.

  4. Total Daily Dose of Insulin [ Time Frame: during hospitalization, average 5 days ]
  5. ICU Need [ Time Frame: during hospitalization, average 5 days ]
    Need for ICU care (transfer to ICU)

  6. Composite Cardiac Complications [ Time Frame: during hospitalization, average 5 days ]
    Cardiac complications are defined as myocardial infarction, cardiac arrhythmia requiring medical treatment, congestive heart failure, or cardiac arrest.

  7. Acute Renal Failure [ Time Frame: during hospitalization, average 5 days ]
    Acute renal failure is defined as a clinical diagnosis of acute renal failure with documented new-onset abnormal renal function (serum creatinine > 2.2 mg/dL or an increment > 0.5 mg/dL from baseline).

  8. Hospital Mortality [ Time Frame: during hospitalization, average 5 days ]
    Hospital mortality. Mortality is defined as death occurring during admission

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01378117

United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Emory University Hospital
Atlanta, Georgia, United States, 30324
Sponsors and Collaborators
Emory University
Merck Sharp & Dohme Corp.
Principal Investigator: Guillermo Umpierrez, MD Emory University SOM

Publications of Results:
Responsible Party: Guillermo Umpierrez, Professor of Medicine, Emory University Identifier: NCT01378117     History of Changes
Obsolete Identifiers: NCT01373268
Other Study ID Numbers: IRB00048954a
First Posted: June 22, 2011    Key Record Dates
Results First Posted: June 12, 2014
Last Update Posted: June 12, 2014
Last Verified: June 2014

Keywords provided by Guillermo Umpierrez, Emory University:
non critical care setting
oral antidiabetic agents
subcutaneous insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Insulin Glargine
Insulin Lispro
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action