Saxagliptin/dapagliflozin is non‐inferior to insulin glargine in terms of β‐cell function in subjects with latent autoimmune diabetes in adults: A 12‐month, randomized, comparator‐controlled pilot study
Authors' conclusion
Saxagliptin/dapagliflozin was non-inferior to glargine in terms of β-cell function in this 12-month, small, phase 2b study, enrolling people with LADA with still viable endogenous insulin production. Weight loss was greater with saxagliptin/dapagliflozin, with no differences in glycaemic control or hypoglycaemic risk.
Study context
- Population
- People with latent autoimmune diabetes in adults (LADA) with fasting C-peptide ≥0.2 nmol/L (0.6 ng/mL)
- Participants
- 33 people
- Comparison
- Saxagliptin/dapagliflozin vs insulin glargine, both on top of metformin
- Primary endpoint
- 2-h mixed meal-stimulated C-peptide AUC
- Follow-up
- 12 months after randomization
Methodological detailsphase 2b, multicentre, open-label, comparator-controlled, parallel-group, non-inferiority, pilot
- Phase 2b
- Multicentre
- Open-label
- Comparator-controlled
- Parallel-group
- Non-inferiority
- Pilot
Primary result
As reported in the abstract
Median C-peptide AUC · 12 months
P for non-inferiority = 0.0087
Secondary outcomes
Median, kg/m²
| Outcome | Saxagliptin/dapagliflozin | Insulin glargine | P value |
|---|---|---|---|
| Median BMI change · end of studyMore weight lost with saxagliptin/dapagliflozin | −0.4 (95% CI −1.6–-0.3) | +0.4 (95% CI −0.3; +1.1) | P = 0.0076 |
HbA1c
- No differences in HbA1c
Safety
- No differences in the number of participants experiencing hypoglycaemic events
Original publication
Saxagliptin/dapagliflozin is non‐inferior to insulin glargine in terms of β‐cell function in subjects with latent autoimmune diabetes in adults: A 12‐month, randomized, comparator‐controlled pilot study. Diabetes Obes Metab. Published 31 January 2024. doi:10.
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