Oral Anti Diabetic Agents in the Hospital

Running, not enrolling · Phase 4

Conditions studied: Diabetes Mellitus

In brief

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).

Key facts

Study ID

NCT04416269

Run by

Emory University

People needed

255

Starts

2020-08-07

Expected to finish

2026-03-01

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Patients receiving OADs in combination with GLP-1 receptor agonists (GLP-1RA) who have HbA1c <7.5% within the past three months
• HbA1c <10%

You may not qualify if…

• 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
• New or recent onset (within two weeks) of coronavirus disease 2019 (COVID-19) infection at the time of admission

Where it is running

• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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