Tirzepatide Versus Intensified Conventional Care After 2 Years of Treatment in Early Type 2 Diabetes : A Randomized Clinical Trial
Primary result · Mean change in HbA1cResult — go to the resultEstimated treatment difference −0.68 percentage points CI −0.84 to −0.51Authors' conclusion
In participants with early T2D uncontrolled with metformin, tirzepatide treatment resulted in superior reductions in HbA1c, weight, and waist circumference, and more participants achieved normoglycemia (HbA1c <5.7%) with tirzepatide than ICC after 2 years.
Study context
- Population
- Adults with early T2D (≤4 years history) inadequately controlled with diet, exercise and metformin; 78 sites in 10 countries
- Participants
- 794 adults
- Comparison
- Tirzepatide vs intensified conventional care
- Primary endpoint
- Noninferiority of tirzepatide to ICC for change in hemoglobin A1c (HbA1c) from baseline
- Follow-up
- 2 years
Methodological detailsopen-label, parallel-group, phase 4, noninferiority
- Open-label
- Parallel-group
- Phase 4
- Noninferiority
Primary result
Mean change in HbA1c · baseline to 2 years
Estimated treatment difference
−0.68 percentage points
CI −0.84 to −0.51
P < 0.001
Change by group
Tirzepatide
−1.99
mean · 95% CI −2.12–-1.87 · percentage points
Intensified conventional care (ICC)
−1.32
mean · CI −1.44–-1.19 · percentage points
Tirzepatidevs ICC
estimated treatment difference −0.68 percentage points (CI −0.84 to −0.51); P < 0.001
As reported in the abstract
Secondary outcomes
| Outcome | Estimated treatment difference (kg) (CI) | P value | |
|---|---|---|---|
| Change in weight · baseline to 2 yearsTreatment regimen estimand | −8.0 (−9.39 to −6.50) | P < 0.001 | |
| −10−505Difference, kg (linear scale) |
| Outcome | Estimated treatment difference (cm) (CI) | P value | |
|---|---|---|---|
| Change in waist circumference · baseline to 2 yearsTreatment regimen estimand | −6.2 (−7.54 to −4.93) | P < 0.001 | |
| −10−505Difference, cm (linear scale) |
Normoglycemia (HbA1c <5.7%) · 2 years
Safety
- The most common adverse events were gastrointestinal in both groups
Original publication
Tirzepatide Versus Intensified Conventional Care After 2 Years of Treatment in Early Type 2 Diabetes : A Randomized Clinical Trial. Ann Intern Med. Published 26 May 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →