| Outcome Measures: |
Primary: Mean Blood Glucose Levels Among the Three Groups at the Time of Hospitalization to 1st Day After Therapy, The primary outcome of the study is to determine differences in glycemic control as measured by mean BG concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with type 2 diabetes mellitus, at the time of admission to the blood glucose levels 24hrs after the therapy, Admission and after 1st day of therapy | Secondary: Number of Patients With Hypoglycemic Events Among the Treatment Groups, Hypoglycemia is defined as blood glucose (BG) reading \<70 mg/dl. The number of hypoglycemia events during hospitalization are recorded and compared among the different groups. BG was measured before each meal and at bedtime (or every 6 h if a patient was not eating) using a point-of-care glucose meter, during hospitalization,up to 10 days|Number of Patients With Severe Hypoglycemic Episodes Among the 3 Treatment Groups, severe hypoglycemic episodes are defined as blood glucose levels \<40 mg/dl. The number of patients with these events during the 5 days of hospitalization are recorded and compared. BG was measured before each meal and at bedtime (or every 6 h if a patient was not eating) using a point-of-care glucose meter., during hospitalization,up to 5 days|Number of Patients With a Mean Daily BG > 240 mg/dL After the 1st Day of Treatment Among the Treatment Groups, Mean daily blood glucose levels are measured to assess the treatment Failures. For study purpose Treatment failure was defined as having three or more consecutive Blood Glucose (BG) readings \> 240 mg/dL or a mean daily BG \>240 mg/dL after the 1st day of treatment. Number of patients with a mean daily BG \> 240 mg/dL after the 1st day of treatment are recorded and compared among the treatment groups. BG was measured before each meal and at bedtime (or every 6 h if a patient was not eating) using a point-of-care glucose meter., during hospitalization,up to 10 days|Mean Total Daily Dose of Insulin in Units/Day Given During Hospitalization Among the Three Groups, The total insulin includes total glargine insulin (units/day) and total lispro insulin (units/day) given to subjects for maintaining blood glucose levels during hospitalization in different groups. The goal of therapy was to maintain a fasting and premeal glucose concentration between 100 and 140 mg/dL. The doses of insulin were adjusted daily according to protocol. The mean amount is calculated among the different groups and compared., during hospitalization, up to 10 days|Mean Length of Stay in Days in the Hospital Among Different Groups, The duration of stay in days in the hospital between the three groups is calculated and mean number of days is measured., during hospitalization, up to 10 days|Number of Subjects With Acute Renal Failure Among the Three Randomized Groups During Hospitalization, 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). The total daily dose of insulin and sitagliptin will be adjusted as per serum creatinine concentration. The total daily insulin dose will be reduced to 0.3 unit/kg in patients with creatinine \>1.7 mg/dl. The dose of sitagliptin will be reduced to 50 mg/day in patients with creatinine clearance between 30-50 ml/min (approximate serum creatinine levels \>1.7 and ≤3.0 mg/dl for men and \>1.5 and ≤2.5 mg/dl for women)., during hospitalization, up to 10 days|Number of Deaths Among the Subjects in Different Groups, Mortality is defined as death occurring during admission among the participants. The number of deaths in each assigned group is calculated., during hospitalization, up to 10 days|Percent of Blood Glucose Readings Within Target Range Between 70 and 140 mg/dL Among the Three Groups After 24 Hrs of Randomized Treatment, The blood glucose within target range is defined as the levels between 70 mg/dL and 140 mg/dL. BG was measured before each meal and at bedtime (or every 6 h if a patient was not eating) using a point-of-care glucose meter (ACCUCHECK; Roche, Indianapolis, IN). In addition, BG was measured at any time if a patient experienced symptoms of hypoglycemia or if requested by the treating physician. the percentage of the readings are calculated and compared, during hospitalization, up to 10 days
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| Locations: |
Grady Memorial Hospital, Atlanta, Georgia, 30303, United States|Emory University Hospital, Atlanta, Georgia, 30324, United States
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