RISE Clinical Trial: Slowing the Progression of Type 2 Diabetes

The RISE Clinical trial revealed surprising results about the progression of type 2 diabetes (T2D), particularly beta-cell function, in adults compared to the youth. This is a summary of the results which were presented at the American Diabetes Association’s 79th Scientific Sessions in San Francisco. For our breaking news coverage of the conference, click here.

Name of Study: Restoring Insulin Secretion (RISE) presented results for Adult Medication Study. 

Goal of Study: The objective of this 12-month study is to determine whether medication or surgical intervention strategies can delay or prevent beta-cell dysfunction in adults and youth with prediabetes or recently diagnosed T2D. In other words, it will determine if there’s a possibility to slow loss of beta function and if the participants could maintain their progress three months after the trial. 

Methods: The study was a randomized trial consisting of 267 adults with impaired glucose tolerance (IGT) and adults who were recently diagnosed with type 2 diabetes. 197 of the participants had IGT, while the remaining 70 had type 2 diabetes. All were randomly assigned to receive one of four treatment regimens:

• 12 months of only taking metformin
• three months of insulin glargine with a target fasting glucose of 4.7-5.5 mmol/L85-100 mg/dL followed by nine months of metformin
• 12 months of liraglutide combined with metformin
• 12 months of placebo

Study Results:

The RISE Clinical Trial results showed the patients in any treatment group weren’t able to sustain beta cell function. Though beta-cell function improved during treatment, there weren’t any lasting benefits post-trial.

The results from this study were compared to youth from the RISE Pediatric Study with the same glucose tolerance abnormalities and thus highlight similarities and differences in the pathogenesis of the disease in the two age groups, as well as the response to interventions aimed at preserving beta-cell function. 

The patients in the youth study received two of the same treatments as the adults—the glargine + metformin and metformin alone. When compared to the adult study, the results from the pediatric trial showed beta-cell function deteriorated during and after treatment. The implications call for more research on the aggressiveness of type 2 diabetes progression in youth.

This article is part of Beyond Type 2’s ADA 2019 coverage. For full ADA 2019 coverage, click here.