RISE Adult Medication Study

What Was Tested

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

Adult participants (ages 20-65) will be randomized to one of the following treatment regimens: (1) blinded placebo, (2) blinded metformin alone, (3) early intensive insulin treatment with basal insulin glargine followed by open-label metformin, (4) the glucagon-like peptide-1 receptor agonist (GLP-1RA) liraglutide plus open-label metformin.

It had four arms (groups): Metformin alone (active comparator), Glargine followed by Metformin (active comparator), Placebo (placebo comparator) and Liraglutide + Metformin (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 267 actual participants took part.

It was open to people of any sex aged from 20 years up to 65 years.

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

Examples of who could join: Age 20-65 years. Body mass index (BMI) ≥25 kg/m2 but ≤50 kg/m2. Drug naïve (no prior to oral glucose lowering agent(s), insulin or other injectable glucose lowering agents).

The full record lists 5 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; active infections; serum alanine transaminase (alt) more than 3 times the upper limit of normal.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2013-04 with completion listed for 2019-02.

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)). Insulin Sensitivity, M/I (time frame: 3-months after a medication washout).

It also tracked 2 secondary outcomes, for example ACPRg and ß-cell Function Measured by Hyperglycemic Clamp Techniques at M12.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Liraglutide in 267 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 and the Liraglutide compound page, all human trials.