Degludec Glargine U300 Hospital Study

• Status: Recruiting
• Trial end date: 2022-03-15
• Target enrollment: 0
• Participant gender: All

Summary

Limited data exist about the use of insulin degludec and insulin glargine U300 in the hospitalized patients. A previous study compared the safety and efficacy of insulin degludec versus insulin glargine U100 for the management of hospitalized patients with type 2 diabetes. However, there is no data comparing the efficacy and safety of insulin degludec versus insulin glargine U300 for the management of hospitalized patients with type 2 diabetes. Accordingly, the proposed study will provide a clinically useful information on the efficacy (blood glucose control) and safety (hypoglycemia) of insulin degludec versus insulin glargine U300 for the management of hospitalized patients with type 2 diabetes.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medanta, The Medicity, India
• Treatments: Insulin Glargine

Criteria

Inclusion Criteria:

1. Males or females 30 years or above admitted to the hospital for elective CABG surgery

2. 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.

3. Study participants must have a randomization total daily dose (TDD) insulin requirement of at least 20 units per day.

4. Signed, informed consent prior to any study procedures.

Exclusion Criteria:

1. Subjects with increased BG concentration, but without a known history of diabetes (stress hyperglycemia).

2. Subjects treated with diet alone (no antidiabetic agents) and admission HbA1c <7%.

3. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria.

4. Patients treated with degludec or glargine U300, or with long-acting weekly GLP1-RA (weekly exenatide, or dulaglutide).

5. 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).

6. Patients with medical and surgical pancreatic disease.

7. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

8. Known or suspected allergy to trial medication(s), excipients, or related products.