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Oral Anti-diabetic Agents

Oral Anti-Diabetes Drugs vs Insulin for Diabetes

Phase 4

Recruiting

Led By Maya Fayfman, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

No known history of diabetes

Gastrointestinal obstruction, adynamic ileus, or expected to require gastrointestinal suction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 days of hospital discharge

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial will compare the effectiveness of oral antidiabetic drugs to insulin therapy in managing diabetes in hospitalized patients with type 2 diabetes.

Who is the study for?

This trial is for adults aged 18-80 with type 2 diabetes, admitted to general medicine and surgery services, not critically ill or pregnant. Participants must have a blood glucose under 250 mg/dl, HbA1c below 10%, be on oral anti-diabetes drugs (OADs), and have functioning kidneys. Those with type 1 diabetes, severe COVID-19, or on steroids can't join.

What is being tested?

The study tests if continuing home oral anti-diabetes drugs in the hospital is as effective as insulin therapy for managing diabetes. It compares daily blood sugar control using these drugs versus basal bolus insulin therapy in hospitalized patients.

What are the potential side effects?

Possible side effects include low blood sugar levels (hypoglycemia), digestive issues due to medication intolerance, potential kidney stress from drug clearance processes, and allergic reactions to the medications used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have type 2 diabetes and am taking oral diabetes medications.

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My blood sugar is under 250 mg/dl and I'm not on long-acting insulin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never been diagnosed with diabetes.

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I have a blockage in my intestines or expect to need stomach pumping.

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I have type 1 diabetes, as indicated by needing insulin or having had ketoacidosis.

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I am currently taking corticosteroid medication.

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My kidney function is low.

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I am critically ill or need heart surgery that requires intensive care.

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I understand the study's purpose and what it involves.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 40 days (hospital stay plus 30 days after discharge)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 40 days (hospital stay plus 30 days after discharge)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 40 days (hospital stay plus 30 days after discharge) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean daily BG concentration

Secondary study objectives

Costs for diabetes specific therapies

Daily dose of insulin

Glycemic variability in participants receiving CGM monitoring

+22 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Oral Anti-diabetes Drugs (OADs) aloneExperimental Treatment3 Interventions

OADs will be continued at same outpatient dosage unless contraindicated

Group II: Basal bolus insulinActive Control3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Continuous glucose monitoring (CGM)

2016

Completed Phase 4

~230

0 / 10Eligibility criteria met