Davies M, et al. - The impacts of oral semaglutide with placebo (primary) and open-label subcutaneous semaglutide (secondary) on glycemic control in patients with type 2 diabetes are compared in this study. The current study showed that the oral semaglutide resulted in better glycemic control than placebo more than 26 weeks among patients with type 2 diabetes. These outcomes support phase 3 studies to evaluate longer-term and clinical outcomes, and in addition to safety.

Methods

• For this research, they designed a phase 2, randomized, parallel-group, dosage-finding, 26-week trial with 5-week follow-up.
• This study was conducted at 100 sites (hospital clinics, general practices, and clinical research centers) in 14 countries between December 2013 and December 2014.
• Of 1106 participants evaluated, 632 with type 2 diabetes and insufficient glycemic control utilizing diet and exercise alone or a stable dose of metformin were randomized.
• Randomization was stratified by metformin utilization.

Results

• They observed that the baseline characteristics were comparable across treatment groups.
• Of the 632 randomized patients (mean age, 57.1 years [SD, 10.6]; men, 395 (62.7%); diabetes duration, 6.3 years [SD, 5.2]; body weight, 92.3 kg [SD, 16.8]; BMI, 31.7 [SD, 4.3]), 583 (92%) completed the trial.
• Mean change in HbA1c level from baseline to week 26 reduced with oral semaglutide (dosage-dependent range, -0.7% to -1.9%) and subcutaneous semaglutide (-1.9%) and placebo (-0.3%); oral semaglutide reductions were significant vs placebo (dosage-dependent estimated treatment difference [ETD] range for oral semaglutide vs placebo, -0.4% to -1.6%; P = .01 for 2.5 mg, <.001 for all other dosages).
• Reductions in body weight were greater with oral semaglutide (dosage-dependent range, -2.1 kg to -6.9 kg) and subcutaneous semaglutide (-6.4 kg) vs placebo (-1.2 kg), and significant for oral semaglutide dosages of 10 mg or more vs placebo (dosage-dependent ETD range, -0.9 to -5.7 kg; P < .001).
• Adverse events were reported by 63% to 86% (371 of 490 patients) in the oral semaglutide groups, 81% (56 of 69 patients) in the subcutaneous semaglutide group, and 68% (48 of 71 patients) in the placebo group; mild to moderate gastrointestinal events were most common.