In a press release issued on May 13, 2022, the FDA announced a novel treatment for T2D that uses a dually-targeted treatment that was more effective than many current treatments when compared in clinical trials. Mounjaro (tirzepatide) injection was approved for use in adults with T2D in addition to modification in diet and increased exercise.
The researchers have found that when compared with placebo, tirzepatide SC administered once weekly in addition to insulin glargine resulted in significant improvements in the control of blood glucose in individuals diagnosed with T2D who otherwise were inadequately controlled. Results were published in February in the Journal of the American Medical Association in advance of the FDA press release. Tirzepatide has been highlighted as a novel, dual glucose–dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist formulated to be administered once weekly.
When embarking on their analysis to assess the efficacy and safety of tirzepatide when it was added to insulin glargine in 475 adult subject patients with T2D, the team conducted a randomized phase III clinical trial that was conducted at 45 medical research centers and hospitals located in eight countries. The subject enrollment began on August 30, 2019, and ended March 20, 2020, and included subjects receiving once-daily insulin glargine either with or without metformin but who remained inadequately controlled. Subjects were randomized to receive either once-weekly injections of either 5 mg (n = 116), 10 mg (n = 119), or 15 mg (n = 120) tirzepatide or placebo (n = 120) over 40 weeks. Tirzepatide was initiated at 2.5 mg/week and escalated by 2.5 mg every 4 weeks until the highest assigned dose was achieved. Follow-up was completed on January 13, 2021.
The researchers established primary endpoints as the mean change from baseline in glycated hemoglobin A1c (HbA1c) at Week 40 with five other key secondary endpoints that included mean change in body weight and percentage of patients achieving prespecified HbA1c levels. The HbA1c changes were reported as -2.11, -2.40, and -2.34% with 5 mg, 10 mg, and 15 mg doses of tirzepatide, respectively, versus -0.86% that was observed with placebo administration. When considering other endpoints, the mean change in body weight was -5.4, -7.5, -8.8, and 1.6 kg with 5 mg, 10 mg, and 15 mg tirzepatide and placebo, respectively, when compared with baseline. When compared with individuals treated with placebo, higher percentages of patients treated with tirzepatide had HbA1c less than 7% (85%-90% vs. 34%).
The researchers reported that treatment was discontinued prematurely by 10%, 12%, 18%, and 3% of participants in the tirzepatide 5 mg, 10 mg, and 15 mg groups and placebo group, respectively. The authors also wrote that when considering alternative diabetic treatments, "Insulins are widely used in patients with type 2 diabetes and inadequate glycemic control with oral glucose-lowering medications. Although increasing the basal insulin dose often improves glycemic control, it can also be associated with increased risk of hypoglycemia and weight gain, resulting in inadequate intensification of insulin dose in clinical practice."
The authors concluded, "The results from the current study provide clinically relevant information relative to the use of tirzepatide in combination with a basal insulin that should be of help to clinicians when this treatment option is considered."
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