Use of Sitagliptin for Stress Hyperglycemia or Mild Diabetes Following Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT01970462|
Recruitment Status : Terminated (Recruitment)
First Posted : October 28, 2013
Results First Posted : May 17, 2018
Last Update Posted : June 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Hyperglycemia||Drug: Sitagliptin Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Use of Sitagliptin for Stress Hyperglycemia or Mild Diabetes Following Cardiac Surgery|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge
Sitagliptin prior to hospital discharge and 6 weeks following discharge.
Other Name: Januvia
Placebo Comparator: Placebo
Patients will receive placebo prior to discharge and 6 weeks after discharge.
Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively
- Difference in Fasting Glucose [ Time Frame: 6 weeks ]Difference in mean fasting glucose at 6 weeks post-discharge.
- Self Monitored Blood Glucose [ Time Frame: 2 weeks ]Mean blood glucose at week 2
- Adherence [ Time Frame: 6 weeks ]adherence defined as 80% of all Sitagliptin doses respectively taken in previous week
- Hypoglycemia [ Time Frame: 6 weeks ]Number of subjects with glucose <70 mg/dl following time of discharge to 6 weeks.
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 ClinicalTrials.gov identifier (NCT number): NCT01970462
|United States, Ohio|
|The Ohio State University Wexner Medical Center|
|Columbus, Ohio, United States, 43203|
|Principal Investigator:||Kathleen M Dungan, MD, MPH||Ohio State University|