748-P: GLP-1 Receptor Agonists Dulaglutide and Semaglutide in Japanese Patients with Type 2 Diabetes—Randomized, Parallel-Group, Multicenter, Open-Label Trial

• Published in: Diabetes (New York, N.Y.) Vol. 72; no. Supplement_1; p. 1
• Main Authors: KIMURA, TOMOHIKO, KATAKURA, YUKINO, SHIMODA, MASASHI, KAWASAKI, FUMIKO, YAMABE, MIZUHO, TATSUMI, FUMINORI, MATSUKI, MICHIHIRO, IWAMOTO, YUICHIRO, ANNO, TAKATOSHI, FUSHIMI, YOSHIRO, KAMEI, SHINJI, KIMURA, YUKIKO, SANADA, JUNPEI, HIRATA, YURIE, NAKANISHI, SHUHEI, MUNE, TOMOATSU, KAKU, KOHEI, KANETO, HIDEAKI
• Format: Journal Article
• Language: English
• Published: New York American Diabetes Association 20.06.2023
• Subjects: Agonists; Antidiabetics; Diabetes; Diabetes mellitus (non-insulin dependent); GLP-1 receptor agonists; Low density lipoprotein; Patient satisfaction; Patients
• ISSN: 0012-1797; 1939-327X
• DOI: 10.2337/db23-748-P

The clinical usefulness of once weekly GLP-1 receptor agonists, dulaglutide (D) and semaglutide (S), on domestically approved doses in Japan, was assessed by the multicenter RCT to compare the efficacy, safety and patient satisfaction of D at a dose of 0.75mg and S at a dose of 0.25-1.0mg in patients with type 2 diabetes. The study protocol was approved by the IRB of Kawasaki Medical School (No.5276-01). A total 120 patients eligible for the criteria with HbA1c of 7% or more were randomly assigned to groups D and S (D:S = 59:61), and 107 subjects completed the trial for 24 weeks (D:S=53:54). Backgrounds of 107 subjects were age 62.7 ± 10.7 years, disease duration 13.9 ± 7.4 years, BMI 29.3 ± 5.9 kg/m2, HbA1c 8.0 ± 0.6%. There were no differences in these parameters between 2 groups. Dose of S was escalated by 4 weeks from 0.25mg to adequate dose for each, and average dose was 0.63±0.24mg. The primary endpoint was the difference of HbA1c level between 2 groups at 24 weeks. The HbA1c level at 24 weeks was significantly lower in S than D (D: 8.1±0.6→7.4±0.8 vs S: 7.9±0.5→ 6.7±0.5%, p<0.0001). Reduction in BMI and VFA levels were also more significant in S (D vs. S), BMI: 29.2→28.8 vs. 29.4→28.1 kg/m2, VFA: 174.5→164.6 vs. 175.8→153.2cm2, respectively (p< 0.05). The achievement rate of HbA1c <7% was higher in S (D vs S; 30.8% vs 70.4%, p<0.0001). The parameters such as LDL-C, ALT, γGTP, and apo B/A1 were decreased, and the L/S ratio was increased only in S. Compared the changes in L/S ratio less than 0.9 at baseline, which is diagnosed as NAFLD by CT, between two groups, the ratio was significantly elevated only in the S, but not in D at 24weeks. Gastrointestinal symptoms were observed in 13.2% of D and 46.3% of S (p<0.01). DTR-QoL scores related to pain and gastrointestinal symptoms were superior in D. This prospective trial demonstrated that S has more pronounced effects on glucose and BMI lowering, as well as a reduction in liver fat percentage and visceral fat area.