Safety of Exenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Treated With Thiazolidinedione Alone or Thiazolidinedione in Combination With Metformin

What Was Tested

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

Patients are expected to be treated with exenatide once weekly for at least 52 weeks.

It had 1 arm (groups): 1 (experimental).

The registry classes the interventions as drug.

Who Took Part

134 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 type 2 diabetes. At least 18 years of age at screening. Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive. If female of child-bearing potential (not surgically sterilized and between menarche and 1-year postmenopause) only. Are not breastfeeding.

The full record lists 12 inclusion and 20 exclusion criteria; among the exclusions: is expected to require coronary artery bypass surgery or angioplasty during the course of the study; have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis; have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine ≥135 μmol/l for males and ≥110 μmol/l for females.

How the Study Was Run

The set-up was single-group and open-label.

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.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2008-10 with completion listed for 2009-07.

It ran at 26 sites in United States (11), Romania (6), Canada (4), Mexico (3) and South Africa (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of Patients Experiencing Adverse Events (time frame: Baseline to Week 52). Assessment of Event Rate of Treatment-Emergent Hypoglycemic Events (time frame: Baseline to Week 52).

It also tracked 9 secondary outcomes, for example Change in HbA1c From Baseline to Week 52, Change in Fasting Serum Glucose From Baseline to Week 52, Change in Body Weight From Baseline to Week 52, Change in Total Cholesterol From Baseline to Week 52, Change in High-density Lipoprotein (HDL) From Baseline to Week 52 and Change in Triglycerides From Baseline to Week 52.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Exenatide in 134 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.