DPP4 Inhibitor in the Hospital

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT01378117
First received: March 7, 2011
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Hospitalization
Hyperglycemia
Drug: Sitagliptin
Drug: sitagliptin and glargine
Drug: glargine and lispro + SSI
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • glucose levels [ Time Frame: during hospitalization, average 5 days ] [ Designated as safety issue: No ]
    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:
  • hypoglycemia [ Time Frame: during hospitalization, average 5 days ] [ Designated as safety issue: Yes ]
    Number of hypoglycemic events (<70 mg/dl)

  • severe hypoglycemia [ Time Frame: during hospitalization, average 5 days ] [ Designated as safety issue: Yes ]
    severe hypoglycemic events (<40 mg/dl).

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

  • Total daily dose of insulin [ Time Frame: during hospitalization, average 5 days ] [ Designated as safety issue: No ]
  • ICU need [ Time Frame: during hospitalization, average 5 days ] [ Designated as safety issue: No ]
    Need for ICU care (transfer to ICU)

  • Composite cardiac complications [ Time Frame: during hospitalization, average 5 days ] [ Designated as safety issue: No ]
    Cardiac complications are defined as myocardial infarction, cardiac arrhythmia requiring medical treatment, congestive heart failure, or cardiac arrest.

  • Acute renal failure [ Time Frame: during hospitalization, average 5 days ] [ Designated as safety issue: No ]
    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).

  • Hospital mortality [ Time Frame: during hospitalization, average 5 days ] [ Designated as safety issue: No ]
    Hospital mortality. Mortality is defined as death occurring during admission


Enrollment: 90
Study Start Date: August 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin + SSI prn
Sitagliptin once daily plus supplemental doses of lispro if needed.
Drug: Sitagliptin
Sitagliptin 50-100mg po once daily plus acqhs supplemental doses of sq lispro if needed for blood glucose elevation.
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: sitagliptin and glargine
Sitagliptin and glargine once daily + correction doses of lispro if needed
Other Name: Januvia (sitagliptin) and 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: glargine and lispro + SSI
Glargine once daily and lispro before meals + supplemental insulin lispro
Other Names:
  • Lantus (glargine)
  • Humalog (lispro)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01378117

Locations
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.
Investigators
Principal Investigator: Guillermo Umpierrez, MD Emory University SOM
  More Information

No publications provided

Responsible Party: Guillermo Umpierrez, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT01378117     History of Changes
Obsolete Identifiers: NCT01373268
Other Study ID Numbers: 48954
Study First Received: March 7, 2011
Last Updated: October 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
diabetes
non critical care setting
hyperglycemia
treatment
oral antidiabetic agents
subcutaneous insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin LISPRO
Glargine
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014