Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes

What Was Tested

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

The purpose of this study is to compare the effects of exenatide once weekly (QW) and insulin detemir with respect to glycemic control, body weight, lipids, safety, tolerability, and patient reported outcomes.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

The registry classes the interventions as drug.

Who Took Part

222 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: have any contraindication for the oad that they have been using; have a known allergy or hypersensitivity to insulin detemir, exenatide or excipients contained in these agents; have been treated with drugs that promote weight loss, within 3 months of screening.

How the Study Was Run

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

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 2009-10 with completion listed for 2011-07.

It ran at 34 sites in United Kingdom (33) and Ireland (1).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 13 secondary outcomes, for example Change in HbA1c From Baseline to Week 26, Change in Body Weight From Baseline to Week 26, Change in Fasting Serum Glucose From Baseline to Endpoint (Week 26), Changes in Systolic Blood Pressure From Baseline to Week 26, Change in Diastolic Blood Pressure From Baseline to Week 26 and Change in Total Cholesterol From Baseline to Endpoint (Week 26).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide and Insulin Detemir in 222 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 Detemir compound page, all human trials.