Diabetes Dialogue: TRANSITION-T2D, with Paloma Rodriguez, MD, and Kevin Pantalone, DO

Data from the TRANSITION-T2D study presented at the 83rd Scientific Sessions of the American Diabetes Association (ADA 2023) suggests use of once-weekly semaglutide 1.0 mg (Ozempic) could help reduce need for insulin use in some people with type 2 diabetes.

Results of the study, which were presented by Paloma Rodriguez, MD, diabetologist and research fellow in endocrinology and metabolism at the Cleveland Clinic, indicate more than 95% of those using semaglutide 1.0 mg were able to fully replace prandial insulin use during the 26-week study, with results also suggesting 57.5% reducing their total daily insulin dose by more than 50%.¹

Funded by a research grant from Novo Nordisk Inc. Investigator Sponsored Studies Program, the TRANSITION-T2D study was launched with the intent of assessing whether use of subcutaneous 1.0 mg could improve glycemic control in patients using multiple daily injections of insulin while also providing a significant reduction in burden of disease management. Launched in 2020, the trial enrolled adult patients aged 18-75 years with type 2 diabetes who had been using a basal/bolus regimen for at least 6 months, an HbA1c of 7.5% or greater on present therapy, and using less than 80 units of total insulin per day.^2,3

Overall, 60 patients were enrolled in the trial. The study cohort had a mean age of 68.6 years, 58% were male, and 62% were White. Investigators pointed out 85% of the cohort had hypertension, 82% had dyslipidemia, 48% were using metformin, and the mean total daily dose of insulin at screening was 64.5 U/kg.

The primary outcome of interest for the study was the proportion of patients achieving an HbA1c of 7.5% or less at week 26. Secondary outcomes of interest included the mean change in weight, daily insulin requirement, and diabetes treatment satisfaction from baseline to week 26 as well as the cumulative number of hypoglycemic events and percentage of subjects needing to resume prandial insulin through week 26.¹

Results of an intention-to-treat analysis at 26 weeks indicate 90% of the semaglutide group and 75% of the MDI group maintained an HbA1c of 7.5% or less, with further analysis suggesting use of semaglutide was associated with a more than 2-fold increase in likelihood of achieving the primary endpoint, but investigators underlined this association failed to reach statistical significance (Odds ratio [OR], 2.61; 95% Confidence interval [CI], 0.65-11.0; P = .18).¹

Analysis of secondary endpoints of interest revealed 97.5% of those in the semaglutide were able to fully replace prandial insulin use during the study, 45% achieved a body weight reduction greater than 10%, and 57.5% experienced a reduction in total daily dose of insulin greater than 50%.¹

At ADA 2023, hosts of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, recorded a special edition episode featuring Rodriguez and principal investigator of the TRANSITION-T2D study Kevin Pantalone, DO, an endocrinologist and director of Diabetes Initiatives in the Department of Endocrinology at the Cleveland Clinic.¹

Relevant disclosures for Dr. Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Dr. Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Relevant disclosures for Dr. Pantalone include Novo Nordisk, AstraZeneca, Bayer Inc., Corcept Therapeutics, Diasome, Eli Lilly and Company, Sanofi, and others. Dr Rodriguez has no disclosures.

References:

1. RODRIGUEZ P, BRESLAW N, BENA JF, et al. 74-lb: Transition from basal bolus to once-weekly subcutaneous semaglutide and basal insulin in patients with type 2 diabetes mellitus (transition-t2d)—a prospective randomized controlled trial. Diabetes. 2023;72(Supplement_1). doi:10.2337/db23-74-lb
2. Transition-T2D (type 2 diabetes). Cleveland Clinic. Accessed June 29, 2023. https://my.clevelandclinic.org/clinical-trials/1325-transition-t2d-type-2-diabetes.
3. Transition from basal/bolus to once-weekly subcutaneous semaglutide and basal insulin in patients with type-2 diabetes mellitus. ClinicalTrials.gov. Accessed June 29, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT04538352.