A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.

What Was Tested

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

The anticipated time on study treatment is 2+ years, and the target sample size if 500+ individuals.

It had three arms (groups): insulin glargine (active comparator), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1072 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Adult patients, 18-75 years of age;. C-peptide (fasting) \>=1.0ng/mL;. BMI \>=25 (\>23 for Asians) and \<=45kg/m2 at screening;.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;; symptomatic poorly controlled diabetes;; clinically symptomatic gastrointestinal disease;.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

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

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2008-11 with completion listed for 2010-12.

It ran at 210 sites in United States (74), France (15), Russia (14), Germany (11), Spain (10) and Poland (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Absolute change from baseline in HbA1c (time frame: 24 weeks).

It also tracked 3 secondary outcomes, for example Relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test and Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 1072 people.

With 1072 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.