Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus

What Was Tested

The trial (phase 3) is built around Exenatide.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 261 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. Have a body mass index (BMI) ≤45 kg/m2.

The full record lists 8 inclusion and 18 exclusion criteria; among the exclusions: have had more than one episode of major (severe) hypoglycemia in the 6 months before entering the study; are pregnant or intend to become pregnant during the study or are sexually active women not actively practicing birth control; women who are breastfeeding.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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.

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

Neither the participants nor the staff measuring them knew who was on Exenatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2008-10 with completion listed for 2010-01.

It ran at 59 sites in United States (40), United Kingdom (7), Puerto Rico (4), Israel (3), Mexico (3) and Greece (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Glycosylated Hemoglobin (HbA1c) (time frame: baseline and 30 weeks).

It also tracked 16 secondary outcomes, for example Change in Fasting Serum Glucose, Change in 7-point Self-monitored Blood Glucose (SMBG) Profile, Change in Total Cholesterol, Change in Low Density Lipoprotein (LDL) Cholesterol, Change in High Density Lipoprotein (HDL) Cholesterol and Change in Triglycerides.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 261 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.