Effect of Subcutaneous Tirzepatide vs Placebo Added to Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes: The SURPASS-5 Randomized Clinical Trial
RCT (n=475) found, in patients with poor glycaemic control, addition of tirzepatide to insulin glargine therapy significantly reduced HbA1c vs placebo (-1.24%, -1.53% & -1.47% for 5mg, 10mg & 15mg doses respectively, all p<0.001). Diarrhoea and nausea were common adverse effects.
Source:
Journal of the American Medical Association
SPS commentary:
A related editorial notes that at the end of the 40-week study period, tirzepatide also improved weight, total cholesterol, triglycerides, and low-density lipoprotein cholesterol. Importantly however, the study did not compare tirzepatide with other treatments that could have been used to target the postprandial glycaemic pattern of the study population. Although patients are likely to embrace a medication with weight loss outcomes, the protocol also leaves unanswered questions about reducing insulin and evaluating the comparative risk of adverse effects. Thus, even though the results of this investigation are important for demonstrating the potential clinical benefit of this dual glucose-dependent insulinotropic polypeptide and GLP-1 receptor agonist, the study may leave clinicians uncertain about when and how to best use tirzepatide to improve clinical outcomes for patients with type 2 diabetes.
In December, both the FDA and EMA accepted Eli Lilly's marketing authorisation applications for tirzepatide for the treatment of type 2 diabetes.