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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/106060
• EU PAS number:
  EUPAS106059
• Study ID:
  106060
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  Primary objective: - 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: - 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. Other secondary objectives: - To compare the real-world effectiveness of tirzepatide vs. oral semaglutide as measured by the proportion of participants achieving HbA1c targets (<5.7%, <6%, ≤6.5%, <7%) after up to 12 months of treatment. - To compare the real-world effectiveness of tirzepatide vs. oral semaglutide as measured by the proportion of participants who achieve weight loss targets (≥3%, ≥5%, ≥10%, ≥15%) after up to 12 months of treatment. - To compare the real-world effectiveness of tirzepatide vs. oral semaglutide as measured by metabolic parameters (waist circumference, blood pressure, serum lipids, liver function, and fasting plasma glucose FPG) after up to 12 months of treatment. - To compare the real-world effectiveness of tirzepatide vs. oral semaglutide as measured by treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire change version DTSQc) after up to 12 months of treatment. - To compare the treatment persistency of tirzepatide vs. oral semaglutide over up to 12 months of treatment.
• Study status:
  Planned

Research institution and networks

Institutions

Eli Lilly and Company

Study timelines

Date when funding contract was signed

Planned: 02/08/2023

Study start date

Planned: 15/12/2023

Date of final study report

Planned: 31/12/2025

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

Eli Lilly Japan K.K., Mitsubishi Tanabe Pharma Corporation

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable