Exenatide Inpatient Trial: A Randomized Controlled Pilot Trial on the Safety and Efficacy of Exenatide (Byetta®) Therapy for the Inpatient Management of Patients With Type 2 Diabetes

What Was Tested

The trial (phase 4) is built around Exenatide and Insulin Glargine.

The purpose of this study is to try and achieve similar glycemic control in general non-Intensive Care Unit (non-ICU) patients with Type 2 Diabetes with exenatide alone or in combination with basal insulin as compared to treatment with basal bolus insulin alone.

The association between hyperglycemia and poor clinical outcomes in patients with diabetes is well established.

It had five arms (groups): Exenatide inpatient (active comparator), Exenatide plus glargine insulin inpatient (active comparator), Basal bolus regimen inpatient (active comparator), Exenatide outpatient (active comparator) and Insulin Only (active comparator).

The registry classes the interventions as drug.

More on the Plan

The investigators will study if treatment with exenatide alone or in combination with basal insulin will result in similar glycemic control and a lower frequency of hypoglycemia than treatment with basal bolus in general non-Intensive Care Unit (non-ICU) patients with Type 2 Diabetes.

Who Took Part

The registry lists 150 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Males or females between the ages of 18 and 80 years discharged after hospital admission from general medicine and surgery services (non-Intensive Care Unit setting). BMI range: \> 25 Kg/m\^2 and \< 45 Kg/m\^2.

The full record lists 5 inclusion and 15 exclusion criteria; among the exclusions: age \< 18 or \> 80 years; patients that required icu care during the hospital admission; recurrent severe hypoglycemia or hypoglycemic unawareness.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Exenatide study did not mask who received what.

It started in 2015-09 with completion listed for 2018-03.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean Daily Blood Glucose Concentration Inpatient (time frame: Duration of hospital stay, an expected average of 10 days). Change in HbA1c Concentration Inpatient (time frame: 12 weeks from discharge).

It also tracked 28 secondary outcomes, for example Mean Fasting Blood Glucose Levels Inpatient, Mean Premeal Blood Glucose Levels Inpatient, Incidence of Hypoglycemic Events Inpatient, Incidence of Hyperglycemic Events Inpatient, Average Number of Days of Hospital Stay and Incidence of the Need for ICU Care Inpatient.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide and Insulin Glargine in 150 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page and the Insulin Glargine compound page, all human trials.