Phase 4
Completed N=201
Sitagliptin for Hyperglycemia in Patients With T2DM Undergoing Cardiac Surgery
Source: ClinicalTrials.gov NCT02556918 ↗Enrolled (actual)
201
Serious AEs
74.1%
Results posted
Dec 2019
Primary outcomePrimary: Number of Patients With Hyperglycemia in the Intensive Care Unit (ICU) — 76; 68 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to determine whether treatment with sitagliptin reduces the frequency and severity of high blood sugar (hyperglycemia) after cardiac surgery and to determine whether treatment with sitagliptin is effective in maintaining blood sugar control in patients with type 2 diabetes (T2D).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Hyperglycemia in the Intensive Care Unit (ICU) |
76; 68 | — |
| PRIMARY Number of Patients With Persistent Hyperglycemia |
58; 59 | — |
| SECONDARY Number of Patients Requiring Continuous Intravenous Insulin Infusion (CII) |
86; 85 | — |
| SECONDARY Mean Blood Glucose (BG) Concentration in the Intensive Care Unit (ICU) |
148.7; 149.8 | — |
| SECONDARY Total IV Insulin in ICU |
100.43; 95.68 | — |
| SECONDARY Mean Insulin Dose Per Day During Intensive Care Unit (ICU) Recovery |
45.9; 46.4 | — |
| SECONDARY Duration of Continuous Intravenous Insulin Infusion (CII) |
27.7; 27.7 | — |
| SECONDARY Number of Patients Requiring Subcutaneous (SQ) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII) |
74; 78 | — |
| SECONDARY Median Number of Days of Subcutaneous (SC) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII) |
4; 4 | — |
| SECONDARY Mean Post-operative Blood Glucose (BG) Concentration |
154.2; 156.5 | — |
| SECONDARY Amount of Subcutaneous (SC) Insulin Taken in Intensive Care Unit (ICU) |
1.0; 2.2 | — |
| SECONDARY Amount of Subcutaneous (SC) Insulin in Intensive Care Unit (ICU) 48 Hours |
0.48; 1.5 | — |
| SECONDARY Number of Subjects With Hyperglycemia in Intensive Care Unit (ICU) |
5; 3 | — |
| SECONDARY Number of Subjects With Hyperglycemia (Blood Glucose Greater Than or Equal to 300 mg/dL) in Non-ICU |
20; 12 | — |
| SECONDARY Number of Patients With Hypoglycemic Events in Intensive Care Unit (ICU) |
8; 6 | — |
| SECONDARY Number of Patients With Hypoglycemic Events in Non-intensive Care Unit (ICU) |
8; 8 | — |
| SECONDARY Number of Patients With Severe Hypoglycemic Events in Intensive Care Unit (ICU) |
0; 0 | — |
| SECONDARY Number of Patients With Severe Hypoglycemic Events in Non-intensive Care Unit (ICU) |
0; 0 | — |
| SECONDARY Composite of Perioperative Complications |
63; 42 | — |
| SECONDARY Duration of Intubation |
0.5; 0.7 | — |
| SECONDARY Length of Intensive Care Unit (ICU) Stay |
2.0; 2.2 | — |
| SECONDARY Total Length of Hospital Stay |
9; 7 | — |
| SECONDARY Number of Intensive Care Unit (ICU) Readmission |
14; 7 | — |
| SECONDARY Number of Cerebrovascular Events |
5; 7 | — |
| SECONDARY Number of Subjects Readmitted to the Hospital |
10; 12 | — |
| SECONDARY Number of Subjects Returning to the ER Within 30 Days |
61; 57 | — |
Eligibility Criteria
Inclusion Criteria
- The ability to provide informed consent
- Ages 18 to 80 years old
- Male or female
- Scheduled to undergo cardiac surgery
- Type 2 Diabetes treated with diet, oral agents,
Exclusion Criteria
- Severely impaired kidney function (glomeruler filtration rate (GFR ) less than 30 ml/min)
- Clinically significant liver failure
- Imminent risk of death (brain death or cardiac standstill)
- Gastrointestinal obstruction or adynamic ileus
- Expected to require gastrointestinal suction
- Clinically relevant pancreatic or gallbladder disease
- Using oral or injectable corticosteroid
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- Female subjects are pregnant or breast feeding at time of enrollment into the study
Data sourced from ClinicalTrials.gov (NCT02556918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.