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Blood glucose management in type 1 diabetes (T1D) remains a challenge, with only ~30% of adults within the recommended consensus guidelines. Novel drugs like glucagon-like peptide-1 receptor agonists (GLP-1RAs) and glucose-dependent insulinotropic polypeptide (GIP)/GLP-1RAs have emerged as promising add-ons to insulin in T1D.
This application has been designed to test in a prospective study whether adding a new medicine called tirzepatide (GIP/GLP-1RA) to the usual insulin therapy would make a difference for people with T1D in terms of better glucose control.
Full description
Glycemic control in type 1 diabetes (T1D) remains a challenge, with ~30% of adults achieving an A1c target of 7%. The glucagon-like peptide-1 receptor agonists (GLP-1RAs) and glucose-dependent insulinotropic polypeptide (GIP)/GLP-1RAs have emerged as a promising therapy in T1D. Retrospective studies have shown patients with T1D can significantly improve glycemic control with a reduction in insulin dose and body weight when long-acting GLP-1RAs or GIP/GLP-1RAs are added to insulin therapy. However, randomized controlled trials (RCT) are still lacking.
This is a prospective, randomized, open-label design. The investigators will enroll 42 participants over 18 years of age with confirmed T1D diagnosis ≥6 months, currently on automatic insulin delivery (AID) therapy for at least three months, with A1C ≥6.5% and ≤10%and BMI ≥23 kg/m2. Participants will be randomized in a 1:1 ratio to either tirzepatide 5.0 mg or continue with the Standard of Care (SoC) for 12 weeks (after a titration phase with the lowest dose of 2.5 mg). The primary endpoint is continuous glucose monitoring (CGM) percent time spent between 3.9 and 10.0 mmol/L (TIR) from baseline to follow-up after 12 weeks of treatment. Secondary endpoints include the change in 24/7 CGM percent time >10.0 mmol/L, 24/7 CGM percent time >13.9 mmol/L, 24/7 CGM percent time <3.9 mmol/L, 24/7 CGM percent time <3.0 mmol/L and the change in body mass index (BMI).
This is the first prospective study to investigate the efficacy and safety of tirzepatide (GIP/GLP1-RAs) as an adjuvant therapy to AID. This study may contribute unique data to significantly improving glucose outcomes, reducing the T1D burden, improving the quality of life, and re-directing attention to further treatment in T1D beyond insulin therapies.
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42 participants in 2 patient groups
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Jose F Garcia-Tirado, PhD; Marie-Aline Gerard, MSc
Data sourced from clinicaltrials.gov
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