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Could diabetes pills replace insulin shots in hospitals?

NCT ID NCT04416269

Disease control Sponsor: Emory University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 01, 2026 · Updated 3 times

Summary

This study compares continuing oral diabetes medications (like metformin) versus switching to insulin in hospitalized adults with type 2 diabetes. About 255 participants will be randomly assigned to either stay on their usual pills or receive insulin injections. The goal is to see if the pills can control blood sugar just as safely and effectively during a hospital stay.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oral antidiabetic drugs (metformin, sulfonylureas, pioglitazone, DPP-4 inhibitors, SGLT2 inhibitors)
What this could lead to
If successful, this could show that many hospitalized patients with type 2 diabetes can safely keep taking their usual pills instead of switching to insulin, simplifying hospital diabetes care.
What could go wrong
This is a moderate-sized Phase 4 trial, so results may not apply to all patients. Oral drugs may not control blood sugar as tightly as insulin in some hospitalized patients, and there is a risk of hypoglycemia or other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

85 people

The number who actually took part.

Started

Aug 2020

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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) * 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

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Conditions

The condition(s) this trial relates to.

diabetes mellitus hyperglycemia type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus

Contacts and locations

Locations

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30322, United States

  • Grady Memorial Hospital

    Atlanta, Georgia, 30322, United States

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