Phase 3
Completed N=175
Efficacy and Safety of a Glargine-based Hospital Discharge Algorithm in Coronary Artery Bypass Graft (CABG) Patients
Poor Glycemic Control
Source: ClinicalTrials.gov NCT01792830 ↗
Enrolled (actual)
175
Serious AEs
2.3%
Results posted
Oct 2015
Primary outcomePrimary: Efficacy, Measured by a Change in HbA1c Levels — 5.09; 5.2; 5.5; 5.8 percent of glycosylated hemoglobin
Summary
Most coronary artery bypass graft surgery (CABG) patients develop high blood sugar while they are in the hospital. No studies have shown what the best insulin regimen is for CABG patients with type 2 diabetes is after going home from the hospital. Patients with high blood sugar and diabetes after cardiac bypass surgery will be followed for 3 months to look at how well their treatment(s) for diabetes work after discharge. Patients with diabetes will be discharged on oral antidiabetic drugs or with insulin glargine injections based on their sugar control. Patients with admission HbA1c 9% will be discharged on glargine at 80-100% of the dose used in the hospital in addition to oral antidiabetic drugs or with insulin glargine and insulin glulisine. The primary outcome will be a change in HbA1c at 4 and 12 weeks after discharge.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy, Measured by a Change in HbA1c Levels |
5.09; 5.2; 5.5; 5.8; 6.9; 6.1 | — |
| SECONDARY Number of Participants Readmitted to the Hospital |
11; 0; 0; 1; 0; 0 | — |
| SECONDARY The Number of Participants Experiencing a Hypoglycemic Event |
1; 0; 1; 0; 0; 0 | — |
| SECONDARY The Number of Participants Experiencing a Severe Hypoglycemic Event |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Experiencing a Hyperglycemic Event |
0; 0; 2; 0; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females between the ages of 18 and 80 years undergoing primary coronary artery bypass graft surgery (CABG).
- Post surgical hyperglycemia (Blood glucose >140 mg/dl)
- Patients with and without a history of type 2 diabetes
Exclusion Criteria
- Patients with severely impaired renal function (serum creatinine ≥3.0 mg/dl or a glomerular filtration rate < 30 ml/min) or clinically significant hepatic failure.
- Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic states.
- Moribund patients and those at imminent risk of death (brain death or cardiac standstill).
- Patients or next-to-kin with mental conditions rendering the subject or family member unable to understand the nature, scope, and possible consequences of the study.
- Female subjects who are pregnant or breast-feeding at time of enrollment into the study.
Data sourced from ClinicalTrials.gov (NCT01792830). 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.