Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)

What Was Tested

The trial (phase 4) is built around Insulin Glargine.

It had three arms (groups): Group 1 (experimental), Group 2 (experimental) and Group 3 (experimental).

The registry classes the interventions as drug.

More on the Plan

The study duration for each patient will be 27 weeks.

Who Took Part

The registry lists 947 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: 18 to 65 years old. Body mass index (BMI) ≥20 kg/m\^2, and ≤40 kg/m\^2. Diabetes duration ≥1 year. Physician decides to and the patient is willing to start basal insulin (BI) treatment. Willing to join the study and sign the informed consent.

The full record lists 15 inclusion and 9 exclusion criteria; among the exclusions: type 1 diabetes patients; patients with acute diabetic complications (including unexplained severe hypoglycemia in the last 6 months); known hypoglycemia unawareness or recurrent hypoglycemia.

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.

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

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2015-09-07 with completion listed for 2018-04-20.

It ran at 44 sites in China (44).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 12 secondary outcomes, for example Percentage of patients achieving the FPG target without hypoglycemia, Percentage of patients achieving FPG target, Change from baseline in HbA1c, Change in FPG, Change in PPG and Change in body weight in each treatment arm.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 947 people.

With 947 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.