Diabetes research and clinical practice · 2025
Combining glucagon-like peptide 1 analogues with sodium-glucose cotransporter 2 inhibitors to treat patients with type 1 diabetes, BMI > 25 kg/m2, and chronic kidney disease - A randomised, controlled pilot study.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Al Ozairi Ebaa, Taghadom Etab, Irshad Mohammad, Yousef Anas Al, AlKandari Jumana, Al-Najim Werd, Alabdulkader Shahd, Miras Alexander D, le Roux Carel W
Аннотация
AIMS: We investigated the safety and efficacy of combining glucagon-like peptide-1 (GLP-1) analogues with sodium-glucose cotransporter 2 inhibitors (SGLT2i) in patients with type 1 diabetes, BMI > 25 kg/m2, and early chronic kidney disease.
METHODS: This single-centre pilot study (NCT05390307) randomised 60 participants to usual care, GLP-1, SGLT2i, GLP-1 + SGLT2i, or GLP-1 + SGLT2i + lifestyle modification for 6 months. The primary endpoint was change in bodyweight. Secondary endpoints included markers of kidney disease, glycaemic, blood pressure, and lipids. Analyses were performed using both intention-to-treat and per-protocol approaches.
RESULTS: In the intention-to-treat analysis, the GLP-1 + SGLT2i + lifestyle group achieved significantly greater bodyweight loss than usual care [-9·6%, (95 %CI -14·4, -4·9), p < 0.001], and SGLT2i alone [-8·0 (95 %CI -12·6, -3·4), p = 0·002]. No significant differences in glycaemia or blood pressure were observed among groups. However, the GLP-1 + SGLT2i + lifestyle showed a reduction in urine albumin creatinine ratio from 784·9mg/g (95 %CI 500·7, 1069·1) to 287·6mg/g (95 %CI -1·6, 576·8), p < 0·001). Adverse events occurred in 50% of participants in both the usual care (n = 6/12) and medication groups (n = 24/48).
CONCLUSIONS: In patients with type 1 diabetes, BMI > 25 kg/m2, and chronic kidney disease, the combining GLP-1 + SGLT2i + lifestyle modification was safe and produced significant weight loss but did not significantly improve metabolic and blood pressure control.
METHODS: This single-centre pilot study (NCT05390307) randomised 60 participants to usual care, GLP-1, SGLT2i, GLP-1 + SGLT2i, or GLP-1 + SGLT2i + lifestyle modification for 6 months. The primary endpoint was change in bodyweight. Secondary endpoints included markers of kidney disease, glycaemic, blood pressure, and lipids. Analyses were performed using both intention-to-treat and per-protocol approaches.
RESULTS: In the intention-to-treat analysis, the GLP-1 + SGLT2i + lifestyle group achieved significantly greater bodyweight loss than usual care [-9·6%, (95 %CI -14·4, -4·9), p < 0.001], and SGLT2i alone [-8·0 (95 %CI -12·6, -3·4), p = 0·002]. No significant differences in glycaemia or blood pressure were observed among groups. However, the GLP-1 + SGLT2i + lifestyle showed a reduction in urine albumin creatinine ratio from 784·9mg/g (95 %CI 500·7, 1069·1) to 287·6mg/g (95 %CI -1·6, 576·8), p < 0·001). Adverse events occurred in 50% of participants in both the usual care (n = 6/12) and medication groups (n = 24/48).
CONCLUSIONS: In patients with type 1 diabetes, BMI > 25 kg/m2, and chronic kidney disease, the combining GLP-1 + SGLT2i + lifestyle modification was safe and produced significant weight loss but did not significantly improve metabolic and blood pressure control.