Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin

What Was Tested

This registered phase 3 trial tested Exenatide and Insulin Aspart.

This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c).

It had two arms (groups): Exenatide Arm (experimental) and Biphasic Insulin Aspart Arm (active comparator).

Subcutaneous injection, twice daily; titration to target blood glucose level.

The registry classes the interventions as drug.

Who Took Part

The registry lists 505 actual participants took part.

It was open to people of any sex aged from 30 years up to 75 years.

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

Examples of who could join: Patients have a body mass index \>25kg/m2 and \<40 kg/m2.

The full record lists 4 inclusion and 19 exclusion criteria; among the exclusions: patients are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study; patients have previously, in this or any other study, received exenatide or glucagon-like peptide-1 analogs; patients have had greater than three episodes of severe hypoglycemia within 6 months prior to screening.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

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

It started in 2003-11 with completion listed for 2008-07.

It ran at 69 sites in Germany (13), United Kingdom (12), Russia (7), Italy (6), Spain (6) and Greece (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Glcosylated Hemoglobin (HbA1c) (time frame: baseline, week 52).

It also tracked 6 secondary outcomes, for example Change in Body Weight, Change in Fasting Serum Glucose, Change in 7-point Self-monitored Blood Glucose (SMBG) Profile, Percentage of Patients With Hypoglycemic Events and Change in Rate of Hypoglycemic Events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide and Insulin Aspart in 505 people.

With 505 participants it is a large trial for this field.

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 Aspart compound page, all human trials.