Effects of Biphasic Insulin Aspart 70/30 vs. Exenatide in Type 2 Diabetes Patients Not Reaching Blood Glucose Targets on Metformin and a Sulfonylurea.

Plain-language guide to NCT00313001: phase 3 randomized trial of Exenatide and Insulin Aspart, 373 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00313001
Phase: phase 3
Status: completed
Start: 2006-04
Completion (planned or actual): 2007-07
Participants: 373 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Diabetes; Diabetes Mellitus, Type 2
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Exenatide and Insulin Aspart.

This trial is conducted in the United States of America (USA).

Patients enrolled in the study will be insulin naive patients who have not achieved glycemic control with metformin and sulfonylurea.

The registry classes the interventions as drug.

Who Took Part

The registry lists 373 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: Type 2 diabetes. Patients that were never treated with insulin before. Current therapy with metformin and a sulfonylurea.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: history of recurrent, severe hypoglycemia; hepatic insufficiency: alt, ast or alkaline phosphatase \> 2.5 times upper limits of laboratory's normal; severe gastrointestinal disease, including gastroparesis.

How the Study Was Run

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

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

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

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2006-04 with completion listed for 2007-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example Safety variables and Patient satisfaction.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide and Insulin Aspart in 373 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compounds

Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.

Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.