Status:
RECRUITING
Oral Anti Diabetic Agents in the Hospital
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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...
Detailed Description
Hyperglycemia in the hospital is common and has been associated with increased hospital complications, length of stay, and mortality. Improving glycemic control has been shown to improve length of sta...
Eligibility Criteria
Inclusion
- 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%
Exclusion
- 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
Key Trial Info
Start Date :
August 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04416269
Start Date
August 7 2020
End Date
May 1 2026
Last Update
August 11 2025
Active Locations (3)
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1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30322
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
3
Grady Memorial Hospital
Atlanta, Georgia, United States, 30322