Oral Anti Diabetic Agents in the Hospital

NCT04416269 | Active Not Recruiting Phase 4 DMC FDA Drug FDA Device

• 3 other identifiers: IRB001170271K23DK124647-012025P013073
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 3

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).

Conditions

Diabetes Mellitus

Keywords

Hyperglycemia; Insulin therapy; Oral therapy; Basal bolus therapy; Mean daily blood glucose; Hospitalization

Outcome Measures

Primary Outcomes (1)

• Mean daily BG concentration

  Mean daily BG concentration will be compared between OADs and basal bolus therapy in hospitalized patients with T2D.

  During hospital stay (up to 10 days)

Secondary Outcomes (25)

• Number of mild hypoglycemic events

  During hospital stay (up to 10 days)

• Number of clinically significant hypoglycemic events

  During hospital stay (up to 10 days)

• Number of severe hypoglycemic severe (<40 mg/dl) events

  During hospital stay (up to 10 days)

• Percent of BG within target range without hypoglycemia

  During hospital stay (up to 10 days)

• Number of episodes of hyperglycemia after the first day of treatment

  During hospital stay (up to 10 days)

Study Arms (2)

Oral Anti-diabetes Drugs (OADs) alone

EXPERIMENTAL

OADs will be continued at same outpatient dosage unless contraindicated

Drug: Oral Anti-diabetes Drugs alone; Drug: Supplemental insulin; Device: Continuous glucose monitoring (CGM)

Basal bolus insulin

ACTIVE COMPARATOR

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.

Drug: Basal bolus insulin; Drug: Supplemental insulin; Device: Continuous glucose monitoring (CGM)

Interventions

Continuous glucose monitoring (CGM) 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.

Also known as: Dexcom

Basal bolus insulin; Oral Anti-diabetes Drugs (OADs) alone

Oral Anti-diabetes Drugs alone 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.

Also known as: metformin, sulfonylureas, pioglitazone, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose co-transporter 2 (SGLT2) inhibitors

Oral Anti-diabetes Drugs (OADs) alone

Basal bolus insulin DRUG

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

Also known as: glargine, detemir

Basal bolus insulin

Supplemental insulin DRUG

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

Also known as: Humalog, Novolog

Basal bolus insulin; Oral Anti-diabetes Drugs (OADs) alone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)
• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (3)

Emory University Hospital Midtown

Atlanta, Georgia, 30322, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hyperglycemia

Interventions

Metformin; Sulfonylurea Compounds; Pioglitazone; Insulin Glargine; Insulin Detemir; Insulin Lispro; Insulin Aspart; Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Urea; Amides; Sulfones; Sulfur Compounds; Thiazolidinediones; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Maya Fayfman, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 4, 2020
• Study Start: August 7, 2020
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Individual participant data will be made available for sharing beginning 3 months and ending 5 years following article publication.
• Access Criteria: Individual participant data will be made available for sharing to researchers who provide a methodologically sound proposal. The proposal should be directed to maya.fayfman@emory.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (3)