A Concordance Study Comparing Insulin Treatments in Patients With Type 2 Diabetes

What Was Tested

The trial (phase 3) is built around Insulin (regular human).

A study to compare insulin use and its effect on glucose control and other outcomes in patients with Type 2 diabetes who together with their healthcare provider manage their disease by discussing and agreeing on the diabetes treatment chosen from a selection of available treatment options.

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

Treatment options available on the market plus the option of taking Human Insulin Inhalation Powder.

Treatment Options available on the market.

The registry classes the interventions as drug.

Who Took Part

1019 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: Type 2 Diabetes.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: severe congestive heart failure; active malignancy or malignancy within the last 5 years; systemic glucocorticoid therapy.

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 (regular human) and who got the comparison, which limits bias.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2006-06 with completion listed for 2008-05.

It ran at 60 sites in United States (24), Canada (8), Brazil (5), Denmark (4), India (4) and Poland (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: To assess acceptance of insulin therapy (time frame: 9 months). To assess blood sugar control as measured by HbA1c (time frame: baseline, 1,3,5,7,9 months).

It also tracked 5 secondary outcomes, for example To measure changes in HbA1c over time, To assess safety by review of adverse events, To assess patient-reported outcomes based on the W-BQ12 questionnaire, To assess patient-reported outcomes based on the DSC-R questionnaire and To assess patient-reported outcomes based on the DTSQ Questionnaire.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 1019 people.

With 1019 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 (regular human) compound page, all human trials.