BRENZAVVY Safety and Effectiveness Compared to Sitagliptin as an Adjunct to Metformin for Treatment of Type 2 Diabetes Mellitus in Adults
Study Design
A phase 3, randomized, double-blind, active-controlled, parallel-group trial compared the safety and effectiveness of BRENZAVVY, 20 mg, to sitagliptin, 100 mg, in adults with type 2 diabetes mellitus and medicated with metformin (≥ 1500 mg day-1) for at least 8 weeks prior to the screening visit. 386 adults received BRENZAVVY or sitagliptin in addition to ongoing metformin for 24 weeks. Eligible patients were stratified based on their baseline HbA1c (> 8.5% or not). The primary endpoint was the intergroup difference in the change in HbA1c from baseline to week 24.
Study Population
The study population had a mean age of 59.4 years, a mean duration of disease of 8.8 years and mean body mass of 89.9 kg. The mean HbA1c at baseline was 7.99%.
HbA1c
BRENZAVVY was noninferior to sitagliptin for the management of type 2 diabetes mellitus in a population poorly controlled by metformin alone. The model-adjusted mean change in HbA1c from baseline to week 24 was −0.74% in the BRENZAVVY arm and −0.82% in the sitagliptin arm. The improvement in glycemic control was clinically meaningful. At week 24, 75 of the BRENZAVVY treated patients (41.7%) achieved a treatment goal of HbA1c < 7.0%.
Body Mass
BRENZAVVY was superior to sitagliptin for the reduction in body mass from baseline to week 24 for study participants with a BMI ≥ 25 kg m-2 at baseline measurement. Following 24 weeks of treatment with BRENZAVVY, the intergroup model-adjusted difference from those treated with sitagliptin was −2.54 kg.
Fasting Plasma Glucose
BRENZAVVY was superior to sitagliptin for reduction of fasting plasma glucose concentration from baseline to week 24. A decrease by 32.8 mg dL-1 was observed in the BRENZAVVY arm compared to 26.1 mg dL-1 in the sitagliptin arm.
REFERENCES: 1. Halvorsen YD, Lock JP, Zhou W, Zhu F, Freeman MW. A 24-week, randomized, double-blind, active-controlled clinical trial comparing bexagliflozin with sitagliptin as an adjunct to metformin for the treatment of type 2 diabetes in adults. Diabetes Obes Metab. 2019;21(10):2248-2256. doi:10.1111/dom.13801; PMID: 31161692