Degludec Glargine U300 Hospital Study
Type 2 Diabetes
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Males or females 30 years or above admitted to the hospital for elective CABG surgery
- A known history of type 2 diabetes treated with any combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide) or insulin therapy except for degludec and glargine U300.
- Study participants must have a randomization total daily dose (TDD) insulin requirement of at least 20 units per day.
- Signed, informed consent prior to any study procedures.
Exclusion Criteria:
- Subjects with increased BG concentration, but without a known history of diabetes (stress hyperglycemia).
- Subjects treated with diet alone (no antidiabetic agents) and admission HbA1c <7%.
- Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria.
- Patients treated with degludec or glargine U300, or with long-acting weekly GLP1-RA (weekly exenatide, or dulaglutide).
- Patients with history of clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), ongoing corticosteroid therapy (equal to a prednisone dose ≥5 mg/day), or impaired renal function (eGFR< 30 ml/min), or congestive heart failure (NYHA- IV).
- Patients with medical and surgical pancreatic disease.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Known or suspected allergy to trial medication(s), excipients, or related products.
Sites / Locations
- Division Of Endocrinology and Diabetes , Medanta The Medicity Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Degludec
Glargine U300
Study participants with type 2 diabetes undergoing elective coronary artery bypass graft (CABG) surgery will receive 100% of the total daily dose (TDD) given as a basal bolus regimen with degludec once daily plus rapid-acting insulin glulisine before meals. Degludec insulin 100 Units/mL, average dose: 30-40 U/day; Insulin glulisine 100 Units/mL, average dose: 20-40 U/day
Study participants with type 2 diabetes undergoing CABG surgery will receive 100% of the total daily dose (TDD) given as a basal bolus regimen with glargine U300 once daily plus rapid-acting insulin glulisine before meals. Glargine U300;300 Units/mL, average dose: 30-40 U/day; Insulin glulisine 100 Units/mL, average dose: 20-40 U/day