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Recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin | Experimental | Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge |
|
| Placebo | Placebo Comparator | Patients will receive placebo prior to discharge and 6 weeks after discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | Sitagliptin prior to hospital discharge and 6 weeks following discharge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Fasting Glucose | Difference in mean fasting glucose at 6 weeks post-discharge. | 6 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Self Monitored Blood Glucose | Mean blood glucose at week 2 | 2 weeks |
| Adherence | adherence defined as 80% of all Sitagliptin doses respectively taken in previous week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen M Dungan, MD, MPH | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43203 | United States |
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Number of patients with at least one dose of study medication
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in Fasting Glucose | Difference in mean fasting glucose at 6 weeks post-discharge. | 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. | Posted | 6 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Dungan | Ohio State University | 614-685-3333 | kathleen.dungan@osumc.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively |
|
| 6 weeks |
| Hypoglycemia | Number of subjects with glucose <70 mg/dl following time of discharge to 6 weeks. | 6 weeks |
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Other Pre-specified | Self Monitored Blood Glucose | Mean blood glucose at week 2 | 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 | Posted | 2 weeks |
|
|
| Other Pre-specified | Adherence | adherence defined as 80% of all Sitagliptin doses respectively taken in previous week | 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. | Posted | 6 weeks |
|
|
| Other Pre-specified | Hypoglycemia | Number of subjects with glucose <70 mg/dl following time of discharge to 6 weeks. | 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. | Posted | 6 weeks |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | 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 | 0 | 4 | 0 | 4 |
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| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |