Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Exenatide and Liraglutide.

No head to head comparisons between exenatide once weekly and liraglutide have been performed.

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

The registry classes the interventions as drug.

Who Took Part

912 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: Diagnosed with type 2 diabetes. Have a body mass index (BMI) ≤45 kg/m\^2. Metformin plus an SU. Metformin plus pioglitazone.

The full record lists 8 inclusion and 16 exclusion criteria; among the exclusions: if taking metformin and have a contraindication to metformin use; have been treated within 8 weeks of study start with systemic glucocorticoid therapy by oral, intravenous, intra-articular, or intramuscular route; alpha-glucosidase inhibitors (e.g., glyser® \[miglitol\] or precose® \[acarbose\]).

How the Study Was Run

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

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2010-01 with completion listed for 2011-01.

It ran at 108 sites in Germany (13), India (10), Canada (8), France (7), Italy (7) and Hungary (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c From Baseline to Week 26 (time frame: Baseline, Week 26).

It also tracked 9 secondary outcomes, for example Change in Fasting Serum Glucose From Baseline to Week 26, Change in Body Weight From Baseline to Week 26, Change in Total Cholesterol From Baseline to Week 26, Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26, Ratio of Fasting Triglycerides at Week 26 to Baseline and Change in Systolic Blood Pressure (SBP) From Baseline to Week 26.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide and Liraglutide in 912 people.

With 912 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 Liraglutide compound page, all human trials.