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

Author:

Maddaloni Ernesto1ORCID,Naciu Anda M.2,Mignogna Carmen1,Galiero Raffaele3,Amendolara Rocco1,Fogolari Marta45,Satta Chiara6,Serafini Chiara6,Angeletti Silvia45,Cavallo Maria Gisella1,Cossu Efisio6,Sasso Ferdinando Carlo3,Buzzetti Raffaella1ORCID,Pozzilli Paolo78ORCID,

Affiliation:

1. Department of Experimental Medicine Sapienza University of Rome Rome Italy

2. Unit of Metabolic Bone and Thyroid Diseases Fondazione Policlinico Universitario Campus Bio‐Medico Rome Italy

3. Department of Advanced Medical and Surgical Sciences University of Campania Luigi Vanvitelli Naples Italy

4. Unit of Clinical Laboratory Science Campus Bio‐Medico University of Rome Rome Italy

5. Laboratory Unit Fondazione Policlinico Universitario Campus Bio‐Medico Rome Italy

6. Diabetology Unit Policlinico Universitario of Cagliari Cagliari Italy

7. Diabetes Fondazione Policlinico Universitario Campus Bio‐Medico Rome Italy

8. Centre of Immunobiology, Blizard Institute St. Bartholomew's and London School of Medicine London UK

Abstract

AbstractAimTo compare the efficacy and safety of saxagliptin/dapagliflozin and insulin glargine in people with latent autoimmune diabetes in adults (LADA).MethodsIn this phase 2b multicentre, open‐label, comparator‐controlled, parallel‐group, non‐inferiority study, we randomly assigned 33 people with LADA who had a fasting C‐peptide concentration ≥0.2 nmol/L (0.6 ng/mL) to receive 1‐year daily treatment with either the combination of saxagliptin (5 mg) plus dapagliflozin (10 mg) or insulin glargine (starting dose: 10 IU), both on top of metformin. The primary outcome was the 2‐h mixed meal‐stimulated C‐peptide area under the curve (AUC), measured 12 months after randomization. Secondary outcomes were glycated haemoglobin (HbA1c) levels, change in body mass index (BMI), and hypoglycaemic events.ResultsIn the modified intention‐to‐treat analysis, the primary outcome was similar in participants assigned to saxagliptin/dapagliflozin or to insulin glargine (median C‐peptide AUC: 152.0 ng*min/mL [95% confidence interval {CI} 68.2; 357.4] vs. 122.2 ng*min/mL [95% CI 84.3; 255.8]; p for noninferiority = 0.0087). Participants randomized to saxagliptin/dapagliflozin lost more weight than those randomized to insulin glargine (median BMI change at the end of the study: −0.4 kg/m2 [95% CI −1.6; −0.3] vs. +0.4 kg/m2 [95% CI −0.3; +1.1]; p = 0.0076). No differences in HbA1c or in the number of participants experiencing hypoglycaemic events were found.ConclusionsSaxagliptin/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.

Funder

AstraZeneca

Publisher

Wiley

Subject

Endocrinology,Endocrinology, Diabetes and Metabolism,Internal Medicine

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