Hypoglycaemia frequency and physiological response after double or triple doses of once-weekly insulin icodec vs once-daily insulin glargine U100 in type 2 diabetes: a randomised crossover trial
Authors' conclusion
Double or triple doses of once-weekly icodec lead to a similar risk of hypoglycaemia compared with double or triple doses of once-daily glargine U100. During hypoglycaemia, comparable symptomatic and moderately greater endocrine responses are elicited by icodec vs glargine U100.
Study context
- Population
- Adults with T2D (age 18–72 years, BMI 18.5–37.9 kg/m², HbA1c ≤75 mmol/mol [≤9.0%]) on basal insulin ± oral glucose-lowering drugs; Medical University of Graz, Austria
- Comparison
- Double or triple doses of once-weekly icodec vs once-daily glargine U100
- Primary endpoint
- Clinically significant hypoglycaemia (PGnadir <3.0 mmol/l) after double or triple doses during induced hypoglycaemia
Methodological detailssingle-centre, open-label, two-period crossover, Hypoglycaemia induced at steady state after double and triple doses by glucose clamp, PG allowed to fall to no less than 2.5 mmol/l
- Single-centre
- Open-label
- Two-period crossover
- Hypoglycaemia induced at steady state after double and triple doses by glucose clamp, PG allowed to fall to no less than 2.5 mmol/l
Primary result
As reported in the abstract
Icodec (double dose) vs Glargine U100 (double dose): P = 0.63 · Icodec (triple dose) vs Glargine U100 (triple dose): P = 0.14
Further findings
PGnadir ≤2.5 mmol/l — Icodec (double dose) vs Glargine U100 (double dose) · comparable
P = 0.63
| Outcome | Estimate | P value | |
|---|---|---|---|
| Counterregulatory hormone response after triple dosesIcodecvs Glargine U100 | treatment ratio (adrenaline at PG3.0 mmol/l) 2.54 (95% CI 1.69–3.82) | P < 0.001 | |
| Counterregulatory hormone response after triple dosesIcodecvs Glargine U100 | treatment ratio (cortisol at PG3.0 mmol/l) 1.64 (95% CI 1.13–2.38) | P = 0.01 | |
| Counterregulatory hormone response after triple dosesIcodecvs Glargine U100 | treatment ratio (cortisol at PGnadir) 1.80 (95% CI 1.09–2.97) | P = 0.02 | |
| 0.20.5125Ratio (log scale) |
| Outcome | P value |
|---|---|
| PGnadir ≤2.5 mmol/lIcodec (triple dose) vs Glargine U100 (triple dose) · higher with glargine U100 | P = 0.03 |
- Counterregulatory hormone response after triple doses: only participants with PGnadir <3.0 mmol/l and/or hypoglycaemic symptoms analysed
Time to decline from PG 5.5 to 3.0 mmol/l
- No statistically significant treatment differences; 2.9-4.5 h after double dose and 2.2-2.4 h after triple dose
Recovery from hypoglycaemia by constant i.v. glucose
- Recovery took <30 min for all treatments
Counterregulatory hormone response after triple doses
- All counterregulatory hormones increased during hypoglycaemia induction with both insulins at both doses
Hypoglycaemic symptoms score (HSS), vital signs and cognitive function
- No statistically significant treatment differences
Original publication
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