RISE Pediatric Medication Study

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

Pediatric participants (ages 10-19) will be randomized to one of the following treatment regimens: (1) metformin alone or (2) early intensive treatment with basal insulin glargine followed by metformin.

It had two arms (groups): Metformin alone (active comparator) and Glargine followed by Metformin (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 91 actual participants took part.

It was open to people of any sex aged from 10 years up to 19 years.

Healthy volunteers could join, not only people with the condition.

The full record lists 6 inclusion and 25 exclusion criteria; among the exclusions: taking medications that affect glucose metabolism, or has an underlying condition that is likely to require such medications; treatment with insulin for \>1 week preceding screening; active infections.

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.

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

It started in 2013-06-16 with completion listed for 2017-07-12.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: ß-cell Response Measured by Hyperglycemic Clamp (time frame: 3-months after medication washout (Month 15)). M/I (time frame: 3-months after a medication washout).

It also tracked 3 secondary outcomes, for example ACPRg, ß-cell Function Measured by Hyperglycemic Clamp Techniques at M12 and Clamp Measure of Insulin Sensitivity.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 91 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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