A Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes

What Was Tested

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

The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.

It had two arms (groups): Exenatide (BET) (experimental) and Insulin Lispro (BBT) (active comparator).

Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET).

Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1036 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) between ≥ 25 and ≤ 45 kg/m2.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: are currently taking oam that is not described above and not allowed with concurrent use of insulin per local product label; have taken any insulin other than glargine within the 3 months prior to study start for more than 1 week; are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the study start.

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 2009-09 with completion listed for 2012-08.

It ran at 95 sites in France (16), Argentina (8), Germany (8), Netherlands (8), Sweden (7) and Italy (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30 (time frame: Baseline, 30 weeks).

It also tracked 12 secondary outcomes, for example Change in Fasting Blood Glucose (FBG) From Baseline to Week 30, Change in Total Cholesterol From Baseline to Week 30, Change in High Density Lipoprotein (HDL) From Baseline to Week 30, Change in Low Density Lipoprotein (LDL) From Baseline to Week 30, Change in Body Weight From Baseline to Week 30 and Change in Systolic Blood Pressure (SBP) From Baseline to Week 30.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide and Insulin Glargine in 1036 people.

With 1036 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 Glargine compound page, all human trials.