In patients with type 2 diabetes (T2D) and moderate-to-severe chronic kidney disease (CKD), treatment with dulaglutide produced glycaemic control similar to that of insulin glargine, with a reduced decline in estimated glomerular filtration rate (eGFR). This is finding of the AWARD-7 study published in the journal The Lancet Diabetes & Endocrinology.
Katherine R. Tuttle, Providence Health Care, University of Washington, Spokane, WA, USA, and colleagues to assess the efficacy and safety of dulaglutide in patients with type 2 diabetes and moderate-to-severe chronic kidney disease.
Dulaglutide, a glucagon-like peptide 1 receptor agonist consists of GLP-1 covalently linked to an Fc fragment of human IgG4. It is used for the treatment of T2D and can be used once weekly.
For the study, eligible patients (N=577) were randomized to receive dulaglutide 1.5mg once-weekly , dulaglutide 0.75mg (N=190) once-weekly, or insulin glargine daily , all in combination with insulin lispro, for 52 weeks. HbA1c at 26 weeks with a 0.4% non-inferiority margin was designated as the primary outcome, while secondary outcomes included eGFR and urine albumin-to-creatinine ratio.
- At 26 weeks, dulaglutide was found to be non-inferior to insulin glargine in its effects on HbA1c.
- At 52 weeks, eGFR was higher with dulaglutide 1·5 mg and dulaglutide 0·75 mg than with insulin glargine.
- At 52 weeks, the effects of dulaglutide 1·5 mg and 0·75 mg on UACR reduction were not significantly different from that of insulin glargine.
- Proportions of patients with any serious adverse events were similar across groups, 20% with dulaglutide 1·5 mg, 24% with dulaglutide 0·75 mg, and 27% with insulin glargine).
- Dulaglutide was associated with higher rates of nausea (20% with dulaglutide 1·5 mg and 14% with 0·75 mg, vs 5% with insulin glargine) and diarrhoea (17% with dulaglutide 1·5 mg and 16% with 0·75 mg, vs 7% with insulin glargine) and lower rates of symptomatic hypoglycaemia.
- End-stage renal disease occurred in 38 participants: 4% with dulaglutide 1·5 mg, 7% with dulaglutide 0·75 mg, and 8% with insulin glargine.