Oral Anti Diabetic Agents in the Hospital

NCT ID: NCT04416269

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-07
• Study Completion Date: 2026-05-31

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 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).

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 stay, multi-organ failure, systemic infections, as well as short- and long-term mortality. Clinical guidelines from professional organizations recommend the use of subcutaneous (SQ) insulin as the preferred therapy for glycemic control in general medical and surgical patients with T2D. This approach, however, is labor intensive requiring multiple daily insulin injections, costly, and associated with significant risk of iatrogenic hypoglycemia

Over 75% of patients with T2D are treated with oral antidiabetic drugs (OADs) but due to the lack of safety and efficacy data from randomized controlled trials, clinical guidelines recommend stopping OADs during hospitalization. The current clinical guidelines have raised concerns with the use of OADs including risk of hypoglycemia with sulfonylureas, fluid retention and worsening of heart failure with thiazolidinediones, and risk of metformin-associated lactic acidosis in patients with severe renal impairment. However, several observational studies have reported that the use of OADs results in similar glycemic control without increased risk of complications compared to insulin regimens. A recent observational study that included 17,325 hospitalized patients with T2D, found that patients treated with OADs had similar glycemic control without differences in complications and no increase in rates of hypoglycemia compared to those treated with insulin.

This study 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 hospital patients with T2D. For a subset of participants (50 patients per group), a CGM devise will be placed for the duration of the study to assess parameters of glycemic control and hypoglycemia.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral Anti-diabetes Drugs (OADs) alone

OADs will be continued at same outpatient dosage unless contraindicated

Group Type: EXPERIMENTAL

Oral Anti-diabetes Drugs alone

Intervention Type: DRUG

OADs will be continued at same outpatient dosage unless contraindicated. Participants will be switched to the preferred drug within the category of medication they take at home. Dose adjustment for OADs will be based on clinical/laboratory status. The OAD will be held if the participant is placed on strict nil per os (NPO) and is unable to take oral medications after enrollment.

Supplemental insulin

Intervention Type: DRUG

Supplemental (correction) lispro or aspart insulin following the supplemental/sliding scale standard of care protocol for BG \>140 mg/dl.

Continuous glucose monitoring (CGM)

Intervention Type: DEVICE

A subset of participants (50 per study arm) will be randomized to take part in an optional study where a CGM device will be placed for the duration of the study. CGM reports will be reviewed at the end of the study to assess parameters of glycemic control and hypoglycemia, and not used for insulin dose adjustment.

The Dexcom CGM is a small sensor that inserts just under the skin to continuously monitor glucose levels. Results are transmitted to the wearer's smartphone every five minutes.

Basal bolus insulin

Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) will be used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication will be discontinued on admission.

Group Type: ACTIVE_COMPARATOR

Basal bolus insulin

Intervention Type: DRUG

Basal insulin with glargine or detemir will be used as per the hospital formulary.

Supplemental insulin

Intervention Type: DRUG

Supplemental (correction) lispro or aspart insulin following the supplemental/sliding scale standard of care protocol for BG \>140 mg/dl.

Continuous glucose monitoring (CGM)

Intervention Type: DEVICE

A subset of participants (50 per study arm) will be randomized to take part in an optional study where a CGM device will be placed for the duration of the study. CGM reports will be reviewed at the end of the study to assess parameters of glycemic control and hypoglycemia, and not used for insulin dose adjustment.

The Dexcom CGM is a small sensor that inserts just under the skin to continuously monitor glucose levels. Results are transmitted to the wearer's smartphone every five minutes.

Interventions

Oral Anti-diabetes Drugs alone

OADs will be continued at same outpatient dosage unless contraindicated. Participants will be switched to the preferred drug within the category of medication they take at home. Dose adjustment for OADs will be based on clinical/laboratory status. The OAD will be held if the participant is placed on strict nil per os (NPO) and is unable to take oral medications after enrollment.

Intervention Type: DRUG

Basal bolus insulin

Basal insulin with glargine or detemir will be used as per the hospital formulary.

Intervention Type: DRUG

Supplemental insulin

Supplemental (correction) lispro or aspart insulin following the supplemental/sliding scale standard of care protocol for BG \>140 mg/dl.

Intervention Type: DRUG

Continuous glucose monitoring (CGM)

A subset of participants (50 per study arm) will be randomized to take part in an optional study where a CGM device will be placed for the duration of the study. CGM reports will be reviewed at the end of the study to assess parameters of glycemic control and hypoglycemia, and not used for insulin dose adjustment.

The Dexcom CGM is a small sensor that inserts just under the skin to continuously monitor glucose levels. Results are transmitted to the wearer's smartphone every five minutes.

Intervention Type: DEVICE

Other Intervention Names

metformin; sulfonylureas; pioglitazone; dipeptidyl peptidase-4 (DPP-4) inhibitors; sodium-glucose co-transporter 2 (SGLT2) inhibitors; glargine; detemir; Humalog; Novolog; Dexcom

Eligibility 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
• 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 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)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Maya Fayfman

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maya Fayfman, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory University Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

Grady Memorial Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Maya Fayfman, MD

Role: CONTACT

maya.fayfman@emory.edu

404-778-1664

Facility Contacts

Maya Fayfman, MD

Role: primary

maya.fayfman@emory.edu

4047781664

Maya Fayfman, MD

Role: primary

maya.fayfman@emory.edu

4047781664

Maya Fayfman, MD

Role: primary

maya.fayfman@emory.edu

4047781664

Other Identifiers

1K23DK124647-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00117027

Identifier Type: -

Identifier Source: org_study_id