Evaluation of the Effectiveness and Safety of Physician Versus Patient-led of Insulin Glargine Initiation and Titration in Type 2 Diabetes Mellitus

What Was Tested

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

Primary Objective: To compare patient-led titration (intervention group) versus physician-led titration (usual standard of care) in optimizing the clinical use of insulin glargine in an Asian population of patients with Type 2 diabetes mellitus (T2DM) uncontrolled on oral antidiabetic drugs (OADs).

Secondary Objectives: To determine the difference in glycemic control, safety, quality of life and treatment satisfaction between patient-led titration and usual care.

It had two arms (groups): Intervention group (experimental) and Usual standard of care group (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 555 actual participants took part.

It was open to people of any sex aged from 40 years up to 75 years.

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

Examples of who could join: Diagnosed with T2DM duration of T2DM \> 2 years. Body mass index (BMI) 20 and 40 kg/m2. Willing and able to perform blood glucose monitoring using a blood glucose meter.

The full record lists 6 inclusion and 26 exclusion criteria; among the exclusions: diabetes other than type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agent intake),; current or previous use of insulin (except for previous treatment of gestational diabetes or brief treatment with insulin for \< 1 week),; current treatment with thiazolidinediones,.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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 2010-08 with completion listed for 2012-06.

It ran at 6 sites in China (1), India (1), Japan (1), Pakistan (1), Philippines (1) and Russia (1).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 11 secondary outcomes, for example Mean change in Fasting Plasma glucose (FPG) and Post Prandial blood Glucose (PPG), Evolution of Blood Glucose profiles, Incidence of symptomatic hypoglycemia, Incidence of nocturnal hypoglycemia, Incidence of asymptomatic hypoglycemia and Mean change in body weight in patients.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 555 people.

With 555 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.