Effect of dulaglutide 3.0 and 4.5 mg on weight in patients with type 2 diabetes: Exploratory analyses of AWARD‐11

Abstract

Aim To evaluate the impact of dulaglutide 3.0 and 4.5 mg versus 1.5 mg on body weight in patients with type 2 diabetes (T2D) based on exploratory analyses of the AWARD‐11 trial. Materials and Methods Patients were randomized to once‐weekly dulaglutide 1.5 (n = 612), 3.0 (n = 616) or 4.5 mg (n = 614) for 52 weeks. The primary objective was superiority of dulaglutide 3.0 and/or 4.5 mg over 1.5 mg in HbA1c reduction at 36 weeks. Secondary and exploratory assessments included weight reduction in the overall trial population and baseline body mass index (BMI) and HbA1c subgroups. Results At baseline, patients had a mean age of 57.1 years, HbA1c 8.6% (70 mmol/mol), weight 95.7 kg and BMI 34.2 kg/m2. At 36 weeks, dulaglutide 3.0 and 4.5 mg were superior to 1.5 mg for weight change from baseline (1.5 mg, −3.1 kg; 3.0 mg, −4.0 kg [P = .001]; 4.5 mg, −4.7 kg [P < .001]). Higher dulaglutide doses were associated with numerically greater weight reduction compared with 1.5 mg in each baseline BMI and HbA1c subgroup. Absolute weight reduction increased with increasing BMI category, but percentage weight loss was similar between subgroups. Weight reductions with dulaglutide were greater in patients with lower versus higher baseline HbA1c. Conclusions In patients with T2D, inadequately controlled by metformin, incremental weight loss was observed with dulaglutide 1.5, 3.0 and 4.5 mg doses regardless of baseline BMI or HbA1c. Although absolute weight loss was numerically greater in patients with higher baseline BMI, percentage of weight loss was similar between BMI subgroups.

Efficacy and safety of high‐dose glucagon‐like peptide‐1, glucagon‐like peptide‐1/glucose‐dependent insulinotropic peptide, and glucagon‐like peptide‐1/glucagon receptor agonists in type 2 diabetes

“…The trial design, study population characteristics, and HbA1c‐ and body weight‐lowering effects of the different agents are displayed in Table 2 62‐74 . It is important to take differences in baseline characteristics (age, duration of diabetes, HbA1c, and body weight) and in concomitant glucose‐lowering agents into account when interpreting results.…”

“…The trial design, study population characteristics, and HbA1c-and body weight-lowering effects of the different agents are displayed in Table 2. [62][63][64][65][66][67][68][69][70][71][72][73][74] It is important to take differences in baseline characteristics (age, duration of diabetes, HbA1c, and body weight) and in concomitant glucose-lowering agents into account when interpreting results. Baseline HbA1c varied between 7.9% and 8.3% in all trials, except for a higher HbA1c in SUSTAIN FORTE, AWARD-11, and SURPASS-4 (Table 2).…”

Glucagon‐like peptide‐1 receptor agonist prescribing patterns in adolescents with type 2 diabetes

“…9 In adults, GLP-1RAs have been found to reduce weight, improve glycaemic control, and decrease insulin dosage. [10][11][12][13][14][15][16][17][18] Therefore, GLP-1RAs were an attractive 'off-label' adjunct therapy in youth with T2D and obesity to reduce body weight and HbA1c prior to the FDA approval of liraglutide and exenatide ER. [19][20][21] As more GLP-1RAs become FDA approved, an area of additional research should be to evaluate how prescribing patterns change over time with increasing access to these medications.…”

GLP-1 receptor agonists, polycystic ovary syndrome and reproductive dysfunction: Current research and future horizons

“…The escalation of DULA given once every week in a dose of 3 mg or 4.5 mg achieved further incremental reductions in body weight, regardless of baseline A1C or BMI, compared to 1.5 mg once weekly in patients with T2D. 60 In a recent study, which was conducted in a DHEA-induced PCOS female rat model, 3 different doses of DULA were administered subcutaneously for 3 weeks in the treatment arm. 61 Fifty SD rats were randomized into either the DHEA-induced PCOS arm (n = 40) or the control arm (n = 10).…”