Diabetes Mellitus, Type 2, Hyperglycemia
Conditions
Brief summary
This is a randomized controlled trial to determine the safety and efficacy of Sitagliptin in patients with stress hyperglycemia or mild diabetes following cardiac surgery. Patients will receive Sitagliptin or placebo. Sitagliptin may be of particular use in this patient population due to the effects on hepatic glucose production (a major feature of SH), safety (lack of contra-indications for heart failure or renal failure and no hypoglycemia), and tolerability. The secondary objective of this study is to determine whether the management of patients with persistent insulin requirements following cardiac surgery differs among patients with stress hyperglycemia or mild diabetes.
Interventions
DRUGSitagliptin
Sitagliptin prior to hospital discharge and 6 weeks following discharge.
DRUGPlacebo
Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively
Sponsors
Kathleen Dungan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Either of the following: Mild Diabetes Mellitus or Stress Hyperglycemia * AND: * Cardiac Surgery * Insulin Requirement between 8-30 units subcutaneous on post-op day 3 or later off pressors, off enteral feeding, extubated OR glucose \>150 mg/dL at least twice in a 24 hour period (\>4 hours apart) and otherwise not requiring basal insulin
Exclusion criteria
* use of pressors, mechanical ventilation, or enteral or parenteral feeding within previous 12 hours * glucocorticoids in doses exceeding the equivalent of Prednisone 10 mg/day within the previous 48 hours * left ventricular assist device * percutaneous or laparoscopic surgery * end stage renal disease * end stage liver disease * history of pancreatitis * type 1 diabetes * pregnancy * unable to give consent in english * no phone * prisoners * less than 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Fasting Glucose | 6 weeks | Difference in mean fasting glucose at 6 weeks post-discharge. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Self Monitored Blood Glucose | 2 weeks | Mean blood glucose at week 2 |
| Adherence | 6 weeks | adherence defined as 80% of all Sitagliptin doses respectively taken in previous week |
| Hypoglycemia | 6 weeks | Number of subjects with glucose \<70 mg/dl following time of discharge to 6 weeks. |
Countries
United States
Participant flow
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| 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 | 4 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | Sitagliptin | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 1 participants | 4 participants | 0 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 4 |
| serious Total, serious adverse events | 0 / 1 | 0 / 4 |
Outcome results
Primary
Difference in Fasting Glucose
Difference in mean fasting glucose at 6 weeks post-discharge.
Time frame: 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.
Other Pre-specified
Adherence
adherence defined as 80% of all Sitagliptin doses respectively taken in previous week
Time frame: 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.
Other Pre-specified
Hypoglycemia
Number of subjects with glucose \<70 mg/dl following time of discharge to 6 weeks.
Time frame: 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.
Other Pre-specified
Self Monitored Blood Glucose
Mean blood glucose at week 2
Time frame: 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