DPP4 Inhibitor in the Hospital
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.
|Type 2 Diabetes Mellitus Hospitalization Hyperglycemia||Drug: Sitagliptin Drug: glargine Drug: lispro||Phase 4|
|Study Design:||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|
- 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.
- Hypoglycemia [ Time Frame: during hospitalization, average 5 days ]Number of hypoglycemic events (<70 mg/dl)
- Severe Hypoglycemia [ Time Frame: during hospitalization, average 5 days ]severe hypoglycemic events (<40 mg/dl).
- Hyperglycemia [ Time Frame: during hospitalization, average 5 days ]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 ]
- ICU Need [ Time Frame: during hospitalization, average 5 days ]Need for ICU care (transfer to ICU)
- 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.
- 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).
- Hospital Mortality [ Time Frame: during hospitalization, average 5 days ]Hospital mortality. Mortality is defined as death occurring during admission
|Study Start Date:||August 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: Sitagliptin + SSI prn
Sitagliptin once daily plus supplemental doses of lispro if needed.
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
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
lispro before meals
Other Name: Humalog (lispro)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01378117
|United States, Georgia|
|Grady Memorial Hospital|
|Atlanta, Georgia, United States, 30303|
|Emory University Hospital|
|Atlanta, Georgia, United States, 30324|
|Principal Investigator:||Guillermo Umpierrez, MD||Emory University SOM|