Evaluate the Efficacy and Safety of Insulin in Patients With Type 2 Diabetes

What Was Tested

The trial (phase 3) is built around Insulin Glargine.

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

Intensified Glargine.

HIIP.

Intensified Glargine plus HIIP.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 555 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 mellitus. One or more oral antihyperglycemic medications. Once-daily insulin glargine.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: more than two episodes of severe hypoglycemia during the 6 months prior; have had a lower respiratory infection in the 3 months prior; systemic glucocorticoid therapy.

How the Study Was Run

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

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2006-08 with completion listed for 2008-06.

It ran at 69 sites in United States (24), Germany (8), Spain (7), United Kingdom (7), Canada (5) and India (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): To compare in patients who at study entry have type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications plus once daily insulin glargine, a regimen that may include mealtime AIR Insulin (time frame: 24 weeks).

It also tracked 3 secondary outcomes, for example To measure changes in HbA1c over time and To assess rate and incidence of hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 3, 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.