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Comparison of the effect on glycemic control and quality of life between semaglutide and, liraglutide or dulaglutide in patients with type 2 diabetes -prospective randomized controlled trial- (Semaglutide study)

Study for the effects of semaglutid on glycemic control and quality of life in patients with type 2 diabetes (Semaglutide study)

Nomoto Hiroshi

Hokkaido University Hospital

N-14, W-5, Kita-ku, Sapporo, Hokkaido 060-8648, Japan.

hmiyoshi@med.hokudai.ac.jp

Nakamura Akinobu

Hokkaido University

N-15, W-7, Kita-ku, Sapporo 060-8638, Japan.

+81-11-706-5915

akinbo@huhp.hokudai.ac.jp

Not Recruiting

Nov. 06, 2020

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1) HbA1c 6.0-10.0%
2) BMI >= 22 kg/m2
3) patients who were treated with liraglutide or dulaglutide at least for 12 weeks
4) written informed consent

1) patients with type 2 diabetes who were treated with GLP-1 receptor agonist other than liraglutide or dulaglutide, 2) history of anaphylaxis of semaglutide, 3) unstable retinopathy, 4) severe hepatic dysfunction or renal dysfunction, 5) severe ketosis, diabetic coma, 6) severe infection, surgery, serious trauma, 7) pregnancy,8) patients who are inadequate to enter this study due to the other reasons by physician's judgments

Both

type 2 diabetes

Plan A) Continue liraglutide 0.9-1.8 mg/day or switch to subcutaneous once weekly semaglutide. Participants in the semaglutide group follow an escalation regimen of semaglutide 0.5-1.0 mg (maintenance dose reached after 4 weeks of 0.25 mg semaglutide once weekly).
Plan B) Continue dulaglutide 0.75 mg/week or switch to subcutaneous once weekly semaglutide. Participants in the semaglutide group follow an escalation regimen of semaglutide 0.5-1.0 mg (maintenance dose reached after 4 weeks of 0.25 mg semaglutide once weekly).

D003924

The change in HbA1c at 24 weeks from baseline

1) The change in QOL scores, 2) adverse effects, 3) The change in weight, abdominal circumference, blood pressure and pulse 4) The change in the other blood and urinary tests, 5) The factors associated with improvement of HbA1c and secondary endopoints, 6) Comparison of variation in each group when semaglutide shows surperiority over conventional GLP-1 receptor agonists both in plan A and B

+81-11-706-7934

Oct. 08, 2020

No

none