Safety and Efficacy Study of Exenatide Once Weekly in Adolescents With Type 2 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Exenatide.

It had two arms (groups): EQW (experimental) and Placebo (placebo comparator).

Exenatide once weekly.

Placebo once weekly.

The registry classes the interventions as drug.

More on the Plan

In addition to receiving study medications, all patients will participate in a lifestyle intervention program encompassing diet and physical activity modifications following the signing of the informed consent and assent forms (Visit 1 \[Week -2\]) through the end of the extension period (Week 52).

Patients who do not have height assessments at study-site visits over a 6-month interval prior to discontinuation of study medication will enter the Extended Safety Follow-up Period.

No study medication will be administered during the Extended Safety Follow-up Period.

Blood samples will be collected for calcitonin and carcinoembryonic antigen (CEA) laboratory measurements.

Who Took Part

84 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: Is a child or an adolescent of 10 to \<18 years old, at Visit 1 (Screening). Has been diagnosed with type 2 diabetes mellitus per American Diabetes Association diagnostic criteria. Has a C-peptide of \>0.6 ng/L at Visit 1 (Screening). Hepatic disease (defined by aspartate or alanine transaminase \>3.0 times the upper limit of normal (ULN). Chronic infection (e.g., tuberculosis, human immunodeficiency virus, hepatitis B virus, or hepatitis C virus).

The full record lists 17 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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, care provider, investigator and outcomes assessor.

It started in 2011-12-02 with completion listed for 2020-05-06.

It ran at 35 sites in United States (16), Hungary (5), Mexico (4), Ukraine (4), Israel (3) and Bulgaria (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) to Week 24 (Controlled Assessment Period) (time frame: Baseline (Week 0) and Week 24). Percentage of Patients With On-Treatment Adverse Events (AEs) up to Week 24 (Controlled Assessment Period) (time frame: Day 1 (Week 0) up to Week 24, plus up to a maximum of 90 days follow up). Percentage of Patients Positive for Anti-Drug Antibodies (ADAs) to Exenatide up to Week 24 (time frame: Samples were collected on Day 1 (Week 0), Week 4, Week 8, Week 12 and Week 24).

It also tracked 20 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose (FPG) Concentration to Week 24 (Controlled Assessment Period), Change From Baseline in Body Weight to Week 24 (Controlled Assessment Period), Change From Baseline in Fasting Insulin to Week 24 (Controlled Assessment Period), Change From Baseline in Lipid Profiles to Week 24 (Controlled Assessment Period), Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) to Week 24 (Controlled Assessment Period) and Number of Patients Needing Rescue Medication Due to Failure to Maintain Glycemic Control up to Week 24 (Controlled Assessment Period).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 84 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.