Weight loss in patients with type 2 diabetes receiving once‐weekly dulaglutide plus insulin lispro or insulin glargine plus insulin lispro: A post‐hoc analysis of the AWARD‐4 study across baseline body mass index subgroups. Issue 6 (15th March 2019)

• Record Type: Journal Article
• Authors: Fuechtenbusch, Martin; Aberle, Jens; Heitmann, Elke; Nicolay, Claudia; Jung, Heike
• Is Part Of: Diabetes, obesity & metabolism. Volume 21:Issue 6(2019)
• Page Start: 1340
• Page End: 1348
• Publication Date: 2019-03-15
• Subjects: Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.13658
• Languages: English
• ISSNs: 1462-8902

Abstract

Abstract : Aims: Insulin‐treated patients with type 2 diabetes (T2D) and obesity are challenged in achieving body weight stability or reduction, in addition to glycaemic control. Post‐hoc analyses of body weight and insulin dose data from the AWARD‐4 trial involved comparison of treatment with once‐weekly dulaglutide 1.5 mg (N = 295) or 0.75 mg (N = 293) and treatment with daily insulin glargine (N = 296), each with prandial insulin lispro (± metformin). Materials and methods: Changes in weight and in the proportion of patients without weight gain or with weight loss of at least 3%, 5% or 10% or composites of HbA1c less than 7% without weight gain and weight loss of at least 3% after 52 weeks were compared between the dulaglutide (either dose) groups and the insulin glargine group, overall and by baseline BMI (<30, 30‐<35, ≥35 kg/m 2 ), using analysis of covariance and logistic regression, including interaction terms. Results: The following parameters were statistically significant ( P < 0.01) in favour of the dulaglutide‐treated groups, at lower mean total daily insulin doses, vs the insulin glargine group. The achieved targets were more pronounced with dulaglutide 1.5 mg than with insulin glargine: LSM weight change difference, −3.23 kg; proportion of patients without weight gain, 49.0% vs 19.0%; proportion of patients with weight loss ≥3%, 21.7% vs 5.7% or with weight loss ≥5%, 10.5% vs 2.4%; proportion of patients with HbA1c <7% without weight gain, 26.2% vs 7.9%; proportion of patients with HbA1c <7% and weight loss ≥3%, 11.9% vs 1.4%, respectively. Treatment effect for these parameters was not significantly different across BMI categories. Conclusions: Larger proportions of patients in late‐stage T2D needing treatment intensification achieved glycemic control without weight gain or with weight loss at lower insulin doses with once‐weekly dulaglutide plus daily prandial insulin than with a basal‐bolus insulin regimen, overall and across all three BMI subgroups.