Objective:

To evaluate the efficacy and safety of oral orforglipron in reducing HbA1c levels in patients with inadequately controlled type 2 diabetes.

Approach:

Key Findings:

• Mean HbA1c reductions were 1.58, 1.88, and 1.82 percentage points for 3 mg, 12 mg, and 36 mg of orforglipron, respectively, compared to 0.79 percentage points with placebo.
• Higher proportions of patients achieved HbA1c levels below 7% and 6.5% in the orforglipron groups compared to placebo.
• Body weight decreased by about 3% with the 3-mg dose and about 5% with the 12-mg and 36-mg doses.
• Insulin dose requirements increased less among patients receiving orforglipron compared to placebo.
• Common adverse events were gastrointestinal, generally mild to moderate, with treatment discontinuation rates similar to placebo.

Interpretation:

Limitations:

• Trial duration limited to 40 weeks, restricting long-term safety and efficacy assessment.
• Standardized insulin-titration algorithm may not reflect routine clinical practice.
• Background insulin adjustments may have influenced outcomes.
• Continuous glucose monitoring was not utilized.

Conclusion:

Sources:

• JAMA
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