RISE Adult Medication Study

What this study is testing ClinicalTrials.gov NCT01779362 ↗

Description as written by the study sponsor.

The RISE Adult Medication Study is a 4-arm, 3-center, clinical trial of adults with prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose lowering will lead to recovery of beta-cell function that will be sustained after withdrawal of treatment. 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. The primary clinical question RISE will address is: Are improvements in ß-cell function following 12 months of active treatment maintained for 3 months following the withdrawal of therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal of therapy, and whether biomarkers obtained in the fasting state predict parameters of ß-cell function, insulin sensitivity and glucose tolerance and the response to an intervention.

Treatments tested

• Metformin also known as Glucophage Drug

  Titrated to 1000 mg BID

• Liraglutide also known as Victoza Drug

  Titrated to 1.8 mg/day

• Glargine also known as Insulin glargine, Lantus Drug

  Titrated to target fasting glucose \<90 mg/dl

• Placebo Drug

  Matching to metformin 1000 mg BI