A new study has revealed that off-label use of semaglutide (Ozempic) and tirzepatide (Mounjaro) leads to significant reductions in HbA1c levels and body weight among adults with type 1 diabetes (T1D). The findings of the study were published Diabetes Technology & Therapeutics journal.
GlobalData, a data and analytics company, maintains that these findings suggest a potential new therapeutic approach for improving glycemic control and addressing obesity in T1D, an area with few pharmacologic advancements beyond insulin therapy.
GlobalData’s latest report, “Type 1 Diabetes: Seven-Market Drug Forecast and Market Analysis”, forecasts substantial growth in the T1D market across the seven major markets (7MM). With the potential introduction of non-insulin pharmacologic therapies, the market is expected to expand at a compound annual growth rate (CAGR) of 13.3%, increasing from $2.2 billion in 2023 to $9.9 billion in 2033.
“The findings are particularly relevant as the T1D market continues to evolve, with a growing emphasis on adjunctive therapies to complement insulin regimens. The promising data on semaglutide and tirzepatide in T1D highlights the potential for GLP-1 receptor agonists and dual GIP/GLP-1 receptor agonists to reshape diabetes management beyond type 2 diabetes. These findings suggest that targeted therapies could complement insulin treatment, providing additional benefits in glycemic control and weight management,” Sulayman Patel, Pharma Analyst at GlobalData, said.
The study analyzed data from 150 adults with T1D, divided into semaglutide, tirzepatide, and control groups. After one year, the tirzepatide group experienced an average weight loss of 21.4% and a 0.67 percentage point reduction in HbA1c, while the semaglutide group saw a 9.1% weight loss and similar HbA1c improvements. In contrast, the control group showed no significant changes in weight or glycemic control. These results highlight the potential for these therapies to address critical unmet needs in T1D management.
Key opinion leaders (KOLs) interviewed by GlobalData emphasize the need for additional pharmacologic options beyond insulin to improve glycemic outcomes in T1D. One US-based KOL noted: “Only 20% to 30% of patients achieve their glycemic targets, underscoring the urgent need for effective adjunctive therapies.”
Meanwhile, a Japanese KOL added: “In cases where endogenous insulin secretion is completely depleted, glucose fluctuations remain a significant challenge, highlighting the necessity for alternative therapeutic approaches.” These insights reinforce the importance of expanding treatment options for individuals with T1D.
Patel adds: “From a pharmaceutical market perspective, the off-label success of semaglutide and tirzepatide in T1D carries significant implications for drug development and commercialization. With growing interest in adjunctive therapies, pharmaceutical companies may pursue formal clinical trials to secure regulatory approval for these agents in T1D. However, challenges remain, including safety considerations, regulatory hurdles, and the need for reimbursement models that support expanded indications. The adoption of these therapies could also impact insulin utilization patterns, leading to shifts in market dynamics.”
Despite the promising results, further research is needed before GLP-1 receptor agonists and dual GIP/GLP-1 receptor agonists can be integrated into standard T1D treatment. The potential risk of hypoglycemia, insulin dose adjustments, and patient variability in response requires further evaluation through large-scale, randomized controlled trials. Regulatory agencies will demand comprehensive efficacy and safety data before considering label expansions for these agents in T1D, GlobalData stated.
Patel concludes: “These findings reveal that semaglutide and tirzepatide may not only support glycemic control and weight loss, but also offer a new avenue for mitigating insulin resistance in T1D which is a factor increasingly recognized a s barrier to optimising diabetes management. As research continues to explore their long-term safety and efficacy, semaglutide and tirzepatide could offer a meaningful shift in how T1D is managed—potentially bridging the gap between insulin dependency and broader metabolic control.”
