Efficacy and safety of the SGLT2 inhibitor empagliflozin versus placebo and the DPP-4 inhibitor linagliptin versus placebo in young people with type 2 diabetes (DINAMO): a multicentre, randomised, double-blind, parallel group, phase 3 trial
Authors' conclusion
Empagliflozin provided clinically relevant placebo-corrected reductions in HbA1c, whereas linagliptin did not, and might offer a new treatment option for young people with type 2 diabetes.
Study context
- Population
- Young people aged 10–17 years with T2D, HbA1c 6.5–10.5% [48–91 mmol/mol], previously treated with metformin or insulin; 108 centres in 15 countries262 screened
- Participants
- 158 people
- Comparison
- Empagliflozin vs placebo and linagliptin vs placebo
- Empagliflozinn = 52
- Linagliptinn = 53
- Placebon = 53reference
- Primary endpoint
- Change from baseline in HbA1c
- Follow-up
- 26 weeks
Methodological detailsmulticentre, double-blind, placebo-controlled, parallel group, phase three, re-randomisation at weeks 14 and 26, Safety assessed until week 52
- Multicentre
- Double-blind
- Placebo-controlled
- Parallel group
- Phase three
- Re-randomisation at weeks 14 and 26
- Safety assessed until week 52
Primary result
As reported in the abstract
HbA1c change from baseline · up to week 26
Each group vs placeboAdjusted mean HbA1c change from baseline, % (95% CI)P value
Empagliflozin−9.2 mmol/mol (95% CI −16.4 to −2.1); empagliflozin pooled
−0.84(−1.50 to −0.19)
P = 0.012Linagliptin−3.8 mmol/mol (95% CI −10.8 to 3.3)
−0.34(−0.99 to 0.30)
P = 0.29Safety
Adverse events · up to week 26 · empagliflozin pooled
Severe adverse events · up to week 26
Hypoglycaemia
- Severe hypoglycaemia cases
- 0
- Most frequently reported AE, with higher rates on active drug vs placebo
Original publication
Efficacy and safety of the SGLT2 inhibitor empagliflozin versus placebo and the DPP-4 inhibitor linagliptin versus placebo in young people with type 2 diabetes (DINAMO): a multicentre, randomised, double-blind, parallel group, phase 3 trial. Lancet Diabetes Endocrinol. Published 1 February 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →