Oral Anti Diabetic Agents in the Hospital

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized controlled clinical trial will assess whether continuation of home oral antidiabetic agents during hospitalization can be used as a safe and effective alternative to insulin therapy in the management of diabetes in the hospital. The primary outcome of the study is to determine differences in glycemic control as measured by mean daily blood glucose concentration between oral antidiabetic medications and basal bolus therapy in hospitalized patients with type 2 diabetes (T2D).

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

Details

• Lead Sponsor: Emory University
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Males or females, age 18-80 years admitted to a general medicine and surgery services

• Known history of T2D receiving OADs either as monotherapy or in combination therapy

• Admission BG < 250 mg/dl or randomization BG <250 mg/dl and not receiving basal insulin

Exclusion Criteria:

• No known history of diabetes

• Laboratory evidence of diabetic ketoacidosis

• Subjects with a history of type 1 diabetes (suggested by BMI < 25 requiring insulin therapy or with a history of diabetic ketoacidosis, or ketonuria)

• Meeting any exclusion criteria based on specific contraindications to their home oral therapy

• Acute critical illness or cardiac surgery expected to require admission to a critical care unit

• Gastrointestinal obstruction, adynamic ileus, or expected to require gastrointestinal suction

• Medical or surgical patients expected to be kept NPO for >24-48 hours after admission or after completion of surgical procedure

• Impaired renal function (eGFR <30 ml/min)

• Current treatment with oral or injectable corticosteroid

• Mental condition rendering the subject unable to understand the nature and scope of the study

• Female subjects who are pregnant or breastfeeding at time of enrollment in the study