Trial Outcomes & Findings for Use of Sitagliptin for Stress Hyperglycemia or Mild Diabetes Following Cardiac Surgery (NCT NCT01970462)

Results Overview

Difference in mean fasting glucose at 6 weeks post-discharge.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

8 participants

Primary outcome timeframe

6 weeks

Results posted on

2018-06-18

Participant Flow

Enrolled differs from reported because the study was discontinued early and the group number was not available from the pharmacy for 3 subjects. We provided the participant flow for the 5 individuals for whom the group assignment was available. Of 8 total patients enrolled, 4 completed the study, 3 of whom had group assignments available

Participant milestones

Participant milestones
Measure	Sitagliptin Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge Sitagliptin: Sitagliptin prior to hospital discharge and 6 weeks following discharge.	Placebo Patients will receive placebo prior to discharge and 6 weeks after discharge. Placebo: Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively
Overall Study STARTED	1	4
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Sitagliptin Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge Sitagliptin: Sitagliptin prior to hospital discharge and 6 weeks following discharge.	Placebo Patients will receive placebo prior to discharge and 6 weeks after discharge. Placebo: Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Use of Sitagliptin for Stress Hyperglycemia or Mild Diabetes Following Cardiac Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sitagliptin n=1 Participants Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge Sitagliptin: Sitagliptin prior to hospital discharge and 6 weeks following discharge.	Placebo n=4 Participants Patients will receive placebo prior to discharge and 6 weeks after discharge. Placebo: Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	4 participants n=7 Participants	0 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: The study was discontinued early and the group assignment was not available from the pharmacy for 3 subjects. Therefore we are unable to provide group level data for the outcomes. Among the 4 subjects for whom data was available, the fasting 6 week glucose value was 158, 114, 83, 237 mg/dl.

Difference in mean fasting glucose at 6 weeks post-discharge.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks

Population: The study was discontinued early and the group assignment was not available from the pharmacy for 3 subjects. therefore we are unable to provide group level data for the outcomes. Among the 5 subjects for whom data were available the value was 130, 134.6, 96.5, 132, 98 mg/dl

Mean blood glucose at week 2

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Population: The study was discontinued early and the group assignment was not available from the pharmacy for 3 subjects. therefore we are unable to provide group level data for the outcomes. Among the 5 subjects for whom data were available, 100% were adherent.

adherence defined as 80% of all Sitagliptin doses respectively taken in previous week

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Population: The study was discontinued early and the group assignment was not available from the pharmacy for 3 subjects. therefore we are unable to provide group level data for the outcomes. There was no hypoglycemia reported in any of the 5 subjects for whom data were available at the 6 week timepoint.

Number of subjects with glucose \<70 mg/dl following time of discharge to 6 weeks.

Outcome measures

Outcome data not reported

Adverse Events

Sitagliptin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kathleen Dungan

Ohio State University

Phone: 614-685-3333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place