Glargine U300 Hospital Trial

• Status: Completed
• Trial end date: 2019-03-22
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out if treatment with Glargine U300 when compared to Glargine U100 will result in similar sugar control in patients with Type 2 Diabetes (T2D), who are admitted to the hospital and then transition at home, after discharge from the hospital.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Insulin; Insulin Glargine; Insulin glulisine; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Males or females between > 18 years admitted to a general medicine or surgical service.

• Known histories of T2D treated with either diet alone, oral monotherapy, any combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide) or insulin therapy with the exception of degludec and glargine U300.

• Subjects must have an admission/randomization BG > 140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 mEq/L, pH < 7.30, or positive serum or urinary ketones).

Exclusion Criteria:

• Subjects with increased BG concentration, but without a known history of diabetes.

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

• Patients with acute critical or surgical illness admitted to the ICU or expected to require admission to the ICU.

• Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (eGFR< 30 ml/min).

• Mental condition rendering the subject 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.