Metformin monotherapy in children and adolescents with type 2 diabetes mellitus in Japan

Diabetology International
Nobuo MatsuuraStudy Group of the Pediatric Clinical Trial of Metformin in Japan

Abstract

To evaluate the safety and effectiveness of metformin monotherapy for 52 weeks, including 24 weeks of treatment and a 28-week extension period for evaluation of long-term safety, in 37 Japanese pediatric patients with type 2 diabetes mellitus. This study design was an open-label, non-randomized, multicenter trial. The primary effectiveness endpoint was the changes from baseline to the final visit at 24 weeks in HbA1c. The secondary endpoints were the rate for achieving the treatment goal, and the changes in glycated albumin, fasting blood glucose, fasting insulin, HOMA-IR, and fasting serum lipids. Metformin was administrated at the dose of 500 mg/day up to a maximum of 2000 mg/day taken in two or three divided doses. The mean change of HbA1c at the final visit at 24 weeks for 20 metformin-naïve patients (Group A) was - 0.66 ± 0.95% and that of 17 already-on metformin patients (Group B) was - 0.98 ± 1.62%. These figures proved the effectiveness of metformin as defined before the study. Secondary effectiveness endpoints were also improved. The improvement of blood glucose, fasting insulin and serum lipid levels proved the effectiveness of metformin without increasing body weight. Adverse effects such as nausea and diarrhea were ...Continue Reading

References

Sep 17, 2009·Pediatric Diabetes·Arlen L RosenbloomGeorgeanna J Klingensmith
May 1, 2012·The New England Journal of Medicine·UNKNOWN TODAY Study GroupFrancine Kaufman
Jan 30, 2013·Pediatrics·Kenneth C CopelandUNKNOWN American Academy of Pediatrics
Jan 1, 2014·World Journal of Diabetes·Thomas Reinehr
Apr 8, 2014·Mayo Clinic Proceedings·Sumana Narasimhan, Ruth S Weinstock
Sep 4, 2014·Pediatric Diabetes·Phil ZeitlerUNKNOWN International Society for Pediatric and Adolescent Diabetes
Feb 19, 2015·Pediatric Diabetes·Megan M KelseyUNKNOWN Treatment Options for Type 2 Diabetes in Adolescents and Youth Study Group
Feb 24, 2015·The Journal of Pediatrics·Carolyn E Ievers-LandisUNKNOWN Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study Group
Jul 15, 2015·Current Medical Research and Opinion·Leslie Hazel-FernandezJonathan Bouchard
Jan 25, 2016·Current Diabetes Reports·Petter BjornstadKristen J Nadeau

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Citations

Jun 3, 2021·Diabetologia·Laura Pyle, Megan M Kelsey

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