Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Exenatide.

It had three arms (groups): Placebo (placebo comparator), one (experimental) and one (experimental).

Subcutaneous injection, twice a day.

Subcutaneous injection, twice a day.

Subcutaneous injection, twice a day.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 122 actual participants took part.

It was open to people of any sex aged from 10 years up to 17 years.

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

Examples of who could join: Have a history of type 2 diabetes with the original diagnosis based on at least one American Diabetes Association (ADA) diagnostic criteria. Have fasting C-peptide \>0.6 ng/mL.

The full record lists 9 inclusion and 9 exclusion criteria; among the exclusions: patients will be excluded from the study if they meet any of the following criteria:; have previously been exposed to exenatide or, completed or withdrawn from this study or any other study investigating exenatide; are unwilling or unable to inject the study medication.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Exenatide and who got the comparison, which limits bias.

The Exenatide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Exenatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2008-05-30 with completion listed for 2019-04-18.

It ran at 53 sites in United States (31), Mexico (7), South Africa (4), Brazil (3), India (3) and Russia (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Adjusted Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 28 (time frame: Baseline (Day 1) and Week 28). Number of Participants With Post-Treatment Adverse Events of Special Interest (AESI) During Safety Follow-up Period (time frame: From 1 day after the Week 28/ED visit to 3 years after Week 28/ED visit).

It also tracked 7 secondary outcomes, for example Adjusted Change From Baseline in Body Weight Through Week 28, Adjusted Change From Baseline in Fasting Serum Glucose (FSG) at Week 28, Adjusted Change From Baseline in Self-Monitored Blood Glucose (SMBG) at Week 28, Adjusted Change From Baseline in Fasting Serum Insulin at Week 28, Adjusted Change From Baseline in Homeostasis Model Assessments - Beta-Cell Function (HOMA-B) and Insulin Sensitivity (HOMA-S) at Week 28 and Percentage of Participants Discontinuing the Study Due to Failure to Maintain Glycemic Control Through Week 28.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 122 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, all human trials.