Efficacy and Safety of a Glargine-based Hospital Discharge Algorithm in Coronary Artery Bypass Graft (CABG) Patients

NCT01792830 | Completed Phase 3 Results DMC

• 1 other identifier: IRB00056365
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 3

Brief 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 \< 7% (a laboratory value that shows the average blood sugar level in the body over 3 months) will be discharged on the same diabetes medications that they used before coming to the hospital. Those with an HbA1c between 7% and 9% will be discharged on insulin glargine at 50%-80% of the dose used in the hospital and oral antidiabetic drugs. Those with an 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.

Conditions

Poor Glycemic Control

Keywords

Coronary Artery Bypass Graft surgery

Outcome Measures

Primary Outcomes (1)

• Efficacy, Measured by a Change in HbA1c Levels

  Change in the level of HbA1c in a one month period after discharge from the hospital. The A1c test result is reported as a percentage. Higher percentages indicate higher blood glucose levels in the previous three months. A normal HbA1c level is below 5.7 percent.

  One month after hospital discharge

Secondary Outcomes (4)

• Number of Participants Readmitted to the Hospital

  3 months after discharge

• The Number of Participants Experiencing a Hypoglycemic Event

  3 months after discharge

• The Number of Participants Experiencing a Severe Hypoglycemic Event

  3 months after discharge

• Number of Participants Experiencing a Hyperglycemic Event

  3 months after discharge

Study Arms (7)

Control HbA1c < 7%

NO INTERVENTION

Subjects not requiring coronary artery bypass graft surgery (CABG), with no history of diabetes with HbA1c \<7% not requiring subcutaneous insulin in the hospital will be discharged on no antidiabetic therapy.

Diabetic/ Metformin and 50-Glargine HbA1c 7%- 9%

ACTIVE COMPARATOR

Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c between 7% and 9% requiring subcutaneous insulin therapy in the hospital will be discharged on oral metformin and a single dose of basal (glargine) insulin at 50% of total daily hospital dose.

Drug: Metformin; Drug: Glargine insulin

Diabetic/ Metformin and 80-Glargine HbA1c 7%-9%%

ACTIVE COMPARATOR

Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c 7%- 9% will be discharged on oral metformin and a single dose of basal (glargine) insulin at 80% of total daily hospital dose or with basal bolus regimen at same inpatient total daily insulin dose.

Drug: Metformin; Drug: Glargine insulin

No diabetes/ Metformin only

ACTIVE COMPARATOR

Subjects requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1c \<7% and persistent hyperglycemia requiring subcutaneous (SC) insulin therapy in the hospital will be discharged on oral metformin.

Drug: Metformin

Diabetic/antidiabetic regimen

ACTIVE COMPARATOR

Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c \<7% will be discharged on their same outpatient antidiabetic regimen. Subjects will receive one of the three treatment options based on their blood glucose levels: Metformin alone, both metformin and glargine insulin or glargine alone.

Drug: Metformin; Drug: Glargine insulin

No diabetes/ Insulin only

ACTIVE COMPARATOR

Subjects requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1c \<7% and persistent hyperglycemia will be given subcutaneous (SC) insulin therapy in the hospital.

Drug: Glargine insulin

Diabetes/Insulin only

ACTIVE COMPARATOR

Subjects requiring coronary artery bypass graft surgery (CABG) with an admission HbA1c \>9% and persistent hyperglycemia will be given basal insulin (glargine) once daily, at the same time of the day and rapid-acting insulin (glulisine) before meals.

Drug: Glargine insulin; Drug: Glulisine

Interventions

Metformin DRUG

Metformin is an oral antidiabetic agent used to control high blood glucose levels and is given in divided doses with meals. During treatment initiation and dose titration, the patient's blood glucose levels will be used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient. Patients without a history of diabetes and admission HbA1c \< 7% requiring SC insulin therapy in the hospital will be discharged on metformin monotherapy. Treatment naïve patients with an HbA1c between 7% and 9% prior to admission will be discharged on metformin monotherapy or a combination of metformin and a single dose of subcutaneous insulin.

Also known as: Glucophage

Diabetic/ Metformin and 50-Glargine HbA1c 7%- 9%; Diabetic/ Metformin and 80-Glargine HbA1c 7%-9%%; Diabetic/antidiabetic regimen; No diabetes/ Metformin only

Glargine insulin DRUG

Glargine is a recombinant human insulin analog that exhibits a constant glucose-lowering profile over 24 hours and permits once-daily dosing. It is administered subcutaneously once a day at the same time every day. Patients with an HbA1c between 7% and 9% requiring subcutaneous insulin therapy in the hospital will be discharged on oral metformin and a single dose of glargine insulin at 50% of total daily hospital dose. Patients with an HbA1c \> 9% will be discharged on oral metformin and a single dose of glargine insulin at 80% of total daily hospital dose.

Also known as: Lantus

Diabetes/Insulin only; Diabetic/ Metformin and 50-Glargine HbA1c 7%- 9%; Diabetic/ Metformin and 80-Glargine HbA1c 7%-9%%; Diabetic/antidiabetic regimen; No diabetes/ Insulin only

Glulisine DRUG

Glulisine is an injectable, recombinant insulin analog. The total daily dose varies between 0.5 to 1 unit/kg/day depending on the levels of blood glucose. Glulisine will be given within 15 minutes before a meal or within 20 minutes after starting a meal.

Also known as: Apidra

Diabetes/Insulin only

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (3)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Emory Midtown Hospital

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital

Atlanta, Georgia, 30326, United States

Location

MeSH Terms

Interventions

Metformin; Insulin Glargine; insulin glulisine

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The study had participants from other states who lived more than 50 miles away from the hospitals and did not return for their post-operative care or 12 week follow up. Some subjects preferred to complete follow ups via phone and no blood was drawn.

Results Point of Contact

• Title: Dr. Guillermo Umpierrez
• Organization: Emory University

geumpie@emory.edu

404-778-1665

Study Officials

• Guillermo E Umpierrez, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: February 15, 2013
• Study Start: October 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: September 24, 2018
• Results First Posted: October 29, 2015

Record last verified: 2018-08

Locations

US (3)