| Trial ID: | L2076 |
| Source ID: | NCT01845831
|
| Associated Drug: |
Sitagliptin
|
| Title: |
Sitagliptin Therapy in Hospitalized Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01845831/results
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Sitagliptin|DRUG: Basal Bolus|DRUG: Metformin and Sitagliptin|DRUG: Glargine|DRUG: Glargine 50%|DRUG: Glargine 80%
|
| Outcome Measures: |
Primary: Mean Blood Glucose Concentration After First Day of Treatment, The average blood glucose (BG) concentration after the first day of treatment, Duration of Hospitalization (Up to 10 Days)|Mean Percentage of Blood Glucose Readings Between 3.9 - 7.8 mmol/L, Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D., Duration of Hospitalization (Up to 10 Days)|Mean Percentage of Blood Glucose Readings Between 3.9 - 10.0 mmol/L, Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D., Duration of Hospitalization (Up to 10 Days)|Mean Percentage of Blood Glucose Readings Between 5.6 - 7.8 mmol/L, Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D., Duration of Hospitalization (Up to 10 Days)|Mean Percentage of Blood Glucose Readings Greater Than 13.3 mmol/L, Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D., Duration of Hospitalization (Up to 10 Days)|Change in HbA1C, The mean HbA1C measured at 3 months and 6 months post hospitalization. HbA1C is an indicator of diabetes control; below 6.0% is normal, 6.0% to 6.4% indicates prediabetes, and 6.5% or over indicates diabetes., Post Hospital Discharge Month 3, Month 6 | Secondary: Number of Participants With a Hypoglycemic Event, The number of participants who had a hypoglycemic event during hospitalization., Duration of Hospitalization (Up to 10 Days)|Total Daily Insulin Dose, Daily insulin requirement (units per day)., Duration of Hospitalization (Up to 10 Days)|Length of Hospital Stay, Length of hospital stay in days., Duration of Hospitalization (Up to 10 Days)|Acute Renal Failure Rate, Acute renal failure is defined as a clinical diagnosis of acute renal failure with documented new-onset abnormal renal function (increment \> 0.5 mg/dL from baseline)., Duration of Hospitalization (Up to 10 Days)|Hospital Mortality Rate, Mortality is defined as death occurring during admission., Duration of Hospitalization (Up to 10 Days)
|
| Sponsor/Collaborators: |
Sponsor: Emory University | Collaborators: Merck Sharp & Dohme LLC|Temple University|University of Michigan|Ohio University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
292
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-08
|
| Completion Date: |
2016-04
|
| Results First Posted: |
2017-05-30
|
| Last Update Posted: |
2017-05-30
|
| Locations: |
Grady Memorial Hospital, Atlanta, Georgia, 30303, United States|Emory University Hospital, Atlanta, Georgia, 30324, United States|University of Michigan, Ann Arbor, Michigan, 48109, United States|Ohio State University, Columbus, Ohio, 43210, United States|Temple University, Philadelphia, Pennsylvania, 19140, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01845831
|
