A recent study published in Diabetes Technology & Therapeutics has demonstrated that off-label use of semaglutide and tirzepatide leads to significant reductions in glycated haemoglobin (HbA1c) levels and body weight among adults with type 1 diabetes (T1D). 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.
T1D is an autoimmune disease characterised by the destruction of insulin-producing beta cells, leading to absolute insulin deficiency. Despite intensive insulin regimens, many individuals struggle to achieve optimal glycemic control, with weight management further complicating disease management. Currently, insulin remains the cornerstone of T1D treatment, but adjunctive therapies are being explored to enhance patient outcomes. This latest study provides compelling evidence that glucagon-like peptide 1 (GLP-1) receptor agonists and dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonists may have a role in managing T1D beyond their established use in type 2 diabetes.
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Researchers analysed 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 an average 9.1% weight loss and similar HbA1c improvements. In contrast, the control group showed no significant changes in weight or glycemic control. The findings highlight the potential of these therapies to complement insulin therapy and address critical unmet needs in T1D management.
Key opinion leaders (KOLs) have expressed the importance of improving glycemic outcomes in T1D. An American KOL emphasised that “20% to 30% of patients hit their glycemic targets,” underscoring the significant gap in effective disease management. A Japanese KOL further noted: “In typical T1D cases where endogenous insulin secretion is totally depleted, blood glucose levels largely fluctuate and means to avoid this is needed.” These expert insights reinforce the need for additional pharmacologic options beyond insulin to stabilise glucose levels and improve patient outcomes. From a pharmaceutical strategy perspective, the off-label success of semaglutide and tirzepatide in T1D has significant implications for market dynamics. The growing interest in adjunctive therapies for T1D could spur formal clinical trials aimed at regulatory approval for these drugs in T1D, opening new commercial opportunities for pharmaceutical companies. However, significant hurdles remain, including safety concerns, regulatory barriers, and the need for reimbursement models that support expanded indications. Additionally, increased adoption of these therapies may impact insulin utilisation patterns, potentially shifting market dynamics in insulin sales.
Despite these promising findings, several challenges must be addressed before GLP-1 receptor agonists and dual GIP/GLP-1 receptor agonists can be integrated into standard T1D treatment. The risk of hypoglycemia, potential impacts on insulin dosing, and variations in patient response need to be evaluated through large-scale, randomised controlled trials. Regulatory agencies will require comprehensive efficacy and safety data before considering label expansions for these agents in T1D.
This study highlights a potential paradigm shift in T1D treatment, demonstrating that semaglutide and tirzepatide could play a meaningful role in improving glycemic control and weight management. As further research explores their long-term benefits and safety, these therapies may offer a new avenue for addressing the limitations of insulin monotherapy, potentially reshaping the T1D treatment landscape and market strategy.
