Patients ( N = 9,901) were randomized (1:1) to receive either a once-weekly subcutaneous injection of dulaglutide 1.5 mg or placebo, in addition to the standard of care for type 2 diabetes and CVD of the specific country, during a median follow-up of 5.4 years. Adults aged ≥50 years with either established or newly diagnosed type 2 diabetes and additional CV risk factors or established CVD, aged ≥55 years with subclinical CVD, or aged ≥60 years with two or more CV risk factors were included. Briefly, this was a multicenter, global, randomized, double-blind, placebo-controlled clinical trial. Research Design and MethodsĪ full description of study methods, efficacy, and safety results from the REWIND CV outcomes trial has been previously published ( 6, 7), and additional details of the REWIND trial can be found at as NCT01394952. The current post hoc analysis assesses whether changes in HbA 1c levels in the dulaglutide 1.5 mg group varied with diabetes duration, microvascular disease (retinopathy and/or nephropathy), or BMI, either separately or combined, and whether the rate of change in HbA 1c during the first 12 months and subsequent 60 months of therapy differed in patients assigned to dulaglutide 1.5 mg versus placebo added to standard care for diabetes. In addition to the CV efficacy of dulaglutide demonstrated in REWIND, HbA 1c outcomes over long-term use is an important clinical consideration to help tailor therapy and further improve and manage diabetes complications. During this trial, patients assigned to dulaglutide had a least-squares mean (LSM) glycated hemoglobin (HbA 1c) that was 0.61% lower than patients assigned to placebo during a median follow-up period of 5.4 years ( 6). The Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) cardiovascular (CV) outcomes trial demonstrated that the addition of dulaglutide 1.5 mg to the standard care for type 2 diabetes and either CV risk factors or previous CV disease (CVD) reduced the hazard of a composite outcome of CV death, nonfatal myocardial infarction, or nonfatal stroke in patients with type 2 diabetes ( 6). Despite the greater rate of HbA 1c increase in the dulaglutide group during this period, mean HbA 1c values remained below baseline in the dulaglutide group and below mean HbA 1c values in the placebo group. The dulaglutide group also experienced a higher rate of HbA 1c increase from 12 to 72 months compared with the placebo group that became nonsignificant after adjustment for diabetes duration, prior microvascular disease, and BMI combined. Slope analyses revealed that the dulaglutide group experienced a higher rate of HbA 1c reduction compared with the placebo group from 0 to 12 months before and after adjustment. Significant reductions were apparent at all time points and were independent of these baseline characteristics. HbA 1c was significantly reduced in patients treated with dulaglutide compared with placebo during 72 months of treatment (least-squares mean difference = −0.61%, P 0.07).
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