Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine

What Was Tested

The trial (not phased) is built around Exenatide and Insulin Glargine.

The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns, HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of insulin glargine and exenatide to metformin.

It had three arms (groups): Exenatide (active comparator), Insulin Glargine (active comparator) and Exenatide + Insulin Glargine (active comparator).

The registry classes the interventions as drug.

More on the Plan

An ancillary study was approved as part of this study.

The purpose of the ancillary study was to use CGM to characterize the glycemic response to a fixed breakfast meal consumed by study participants receiving different medications.

Who Took Part

Enrollment: 60 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Male or female subjects ≥18 and ≤75 years of age.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: previously treated with insulin or incretin-based therapy; treated with a thiazolidinedione within past 6 weeks; taken oral or injected prednisone or cortisone medications in the previous 30 days.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2010-04 with completion listed for 2013-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: HbA1c Change (time frame: baseline to final visit (32 weeks)).

It also tracked 6 secondary outcomes, for example Change From Baseline in Incidence of Hypoglycemia (Frequency), Change From Baseline in Incidence of Hypoglycemia (Degree), Change From Baseline in Glucose Stability (Absolute Hourly Rate of Change in Median Curve), Change From Baseline in CGM Glucose Variability, Change From Baseline in Glucose Exposure (Area Under the Diurnal Median Curve or AUC) and Change From Baseline in Weight Changes.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Exenatide and Insulin Glargine in 60 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.