Tirzepatide (Mounjaro®) Benefit for EArly glycemic and weight managemenT in patients with type 2 diabetes vs. oral semaglutide (Rybelsus®) in real world setting – the T BEAT study (2023-12154)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Drug utilisation

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10BX16) tirzepatide

  tirzepatide

  (A10BJ06) semaglutide

  semaglutide
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  540

Study design details

• Main study objective:
  The main objective is to compare the real-world effectiveness of tirzepatide vs. oral semaglutide as measured by HbA1c and body weight change from baseline after up to 12 months of treatment.
• Outcomes:
  Primary objective is to compare the real-world effectiveness of tirzepatide vs. oral semaglutide as measured by HbA1c change from baseline after up to 12 months of treatment. Key secondary objective is to compare the real-world effectiveness of tirzepatide vs. oral semaglutide as measured by body weight change and percent change from baseline after up to 12 months of treatment.
• Data analysis plan:
  In the efficacy estimand analysis, change from baseline in HbA1c after up to 12 months of treatment will be analyzed for the EAS using a MMRM with index treatment, visit, treatment by visit interaction, and baseline variables with imbalance remaining after performing IPTW despite being used for the PS model as fixed effects. In the ITT estimand analysis, change from baseline in HbA1c after up to 12 months of treatment will be analyzed for the FAS using an ANCOVA model with index treatment and baseline variables with imbalance remaining after performing IPTW despite being used for the PS model as covariates. Missing values for HbA1c at the 12-month evaluation point will be imputed based on participants who discontinued index therapy or initiated some rescue medication before or at 12 months and whose HbA1c values at the 12-month evaluation point are available (‘retrieve dropout’).