Efficacy and safety of once‐weekly efpeglenatide in people with suboptimally controlled type 2 diabetes: The AMPLITUDE‐D , AMPLITUDE‐L and AMPLITUDE‐S randomized controlled trials
Authors' conclusion
In people with T2D suboptimally controlled with oral glucose-lowering drugs and/or BI, QW efpeglenatide was non-inferior to dulaglutide in terms of HbA1c reduction and showed numerically greater improvements than placebo in glycaemic control and body weight, with safety consistent with the GLP-1 RA class.
Study context
- Population
- People with T2D suboptimally controlled with oral glucose-lowering drugs and/or basal insulin (BI)
- Comparison
- QW efpeglenatide vs dulaglutide or placebo
Methodological detailsthree phase 3 trials, multicentre
- Three phase 3 trials
- Multicentre
Primary result
As reported in the abstract
HbA1c change from baseline (AMPLITUDE-D) · week 56
Each group vs dulaglutide 1.5 mgLeast squares mean treatment difference, % (95% CI)
Efpeglenatide 4 mg−0.35 mmol/mol (−2.20, 1.49)
−0.03(−0.20% to 0.14%)
Efpeglenatide 6 mg−0.90 mmol/mol (−2.76, 0.96)
−0.08(−0.25% to 0.09%)
Further findings
Body weight change (AMPLITUDE-D) · baseline to week 56
- Body weight reductions similar across all treatment groups
- ≈3 kg
HbA1c and body weight (AMPLITUDE-L, AMPLITUDE-S)
- Numerically greater reduction in HbA1c and body weight at all efpeglenatide doses vs placebo
Safety
ADA level 2 hypoglycaemia (< 54 mg/dL [< 3.0 mmol/L])
- AMPLITUDE-D
- ≤ 1%
- AMPLITUDE-L
- ≤ 10%
- AMPLITUDE-S
- ≤ 4%
- Across all treatment groups
Adverse events
- AE profile consistent with other GLP-1 RAs; gastrointestinal AEs most frequent in all three studies
Original publication
Efficacy and safety of once‐weekly efpeglenatide in people with suboptimally controlled type 2 diabetes: The AMPLITUDE‐D , AMPLITUDE‐L and AMPLITUDE‐S randomized controlled trials. Diabetes Obes Metab. Published 26 April 2023. doi:10.
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