Tirzepatide Versus Intensified Conventional Care After 2 Years of Treatment in Early Type 2 Diabetes : A Randomized Clinical Trial
Abstract
Background: Initiation of treatment with tirzepatide, a once-weekly glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist (GLP-1RA), early after a diagnosis of type 2 diabetes (T2D) may establish better and more durable glycemic control than current treatment approaches per guidelines and clinical practice.
Objective: To assess the efficacy and safety of tirzepatide versus intensified conventional care (ICC) in participants with early T2D who have inadequate glycemic control with diet, exercise, and metformin.
Design: Randomized, open-label, parallel-group, phase 4 trial (SURPASS-EARLY). (ClinicalTrials.gov: NCT05433584).
Setting: 78 sites in 10 countries.
Participants: 794 adults with at most 4 years of T2D history treated with metformin.
Intervention: Tirzepatide (15 mg or maximum tolerated dose) or ICC (including GLP-1RAs but excluding tirzepatide) used in clinical practice and supported by local treatment guidelines.
Measurements: The primary objective was to show the noninferiority of tirzepatide to ICC for change in hemoglobin A1c (HbA1c) from baseline to 2 years. Secondary objectives were to show the superiority of tirzepatide for change in HbA1c, weight, and waist circumference.
Results: Tirzepatide was superior to ICC for mean changes from baseline to 2 years in HbA1c (-1.99 percentage points [95% CI, -2.12 to -1.87 percentage points] vs. -1.32 percentage points [CI, -1.44 to -1.19 percentage points]; estimated treatment…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 794 participants or records.
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