BACKGROUND: Type 2 diabetes patients insufficiently controlled withsulfonylurea (SU) are commonly treated by switching to twice-daily premix insulin replacing SU. The efficacy of glargine (GL) added on to SU compared with the premix therapy has not been analyzed in Japan. METHODS: The open-label two-arm study was conducted in 30 type 2 diabetes patients poorly controlled [hemoglobin A(1c) (HbA(1c)) >7.5%] with SU with or without other oral hypoglycemic agents (OHAs). The GL group injected once-daily GL in addition to the OHAs. The aspart 70/30 (70/30) group discontinued SU among the OHAs and injected twice-daily 70/30. Patients were recommended either method in a block random method, and if twice-daily 70/30 was rejected, once-daily GL was selected only at the first time. The insulin dose was titrated to achieve a target fasting plasma glucose of <120 mg/dL and/or HbA(1c) of <7%. RESULTS:Nineteen of 20 patients treated with GL and 11 of 14 patients treated with 70/30 completed the 6-month study. Mean HbA(1c) improved from 8.45% to 7.5% in the GL group and from 9.13% to 7.93% in the 70/30 group. The mean HbA(1c) decrease during 6 months was -0.95% in the GL group and -1.20% in the 70/30 group (P = 0.49). Mean insulin doses at 6 months were 12.0 units/day for the GL group and 26.7 units/day for the 70/30 group. Both therapies were well tolerated without severe hypoglycemia. CONCLUSION: Once-daily GL injection added on to OHAs was equally safe and effective compared with twice-daily injection of aspart 70/30 premix replacing SU in type 2 patients insufficiently controlled with OHAs.
RCT Entities:
BACKGROUND: Type 2 diabetespatientsinsufficiently controlled with sulfonylurea (SU) are commonly treated by switching to twice-daily premix insulin replacing SU. The efficacy of glargine (GL) added on to SU compared with the premix therapy has not been analyzed in Japan. METHODS: The open-label two-arm study was conducted in 30 type 2 diabetespatients poorly controlled [hemoglobin A(1c) (HbA(1c)) >7.5%] with SU with or without other oral hypoglycemic agents (OHAs). The GL group injected once-daily GL in addition to the OHAs. The aspart 70/30 (70/30) group discontinued SU among the OHAs and injected twice-daily 70/30. Patients were recommended either method in a block random method, and if twice-daily 70/30 was rejected, once-daily GL was selected only at the first time. The insulin dose was titrated to achieve a target fasting plasma glucose of <120 mg/dL and/or HbA(1c) of <7%. RESULTS: Nineteen of 20 patients treated with GL and 11 of 14 patients treated with 70/30 completed the 6-month study. Mean HbA(1c) improved from 8.45% to 7.5% in the GL group and from 9.13% to 7.93% in the 70/30 group. The mean HbA(1c) decrease during 6 months was -0.95% in the GL group and -1.20% in the 70/30 group (P = 0.49). Mean insulin doses at 6 months were 12.0 units/day for the GL group and 26.7 units/day for the 70/30 group. Both therapies were well tolerated without severe hypoglycemia. CONCLUSION: Once-daily GL injection added on to OHAs was equally safe and effective compared with twice-daily injection of aspart 70/30 premix replacing SU in type 2 patientsinsufficiently controlled with OHAs.
Authors: Rimke C Vos; Mariëlle Jp van Avendonk; Hanneke Jansen; Alexander N Goudswaard; Maureen van den Donk; Kees Gorter; Anneloes Kerssen; Guy Ehm Rutten Journal: Cochrane Database Syst Rev Date: 2016-09-18
Authors: Rehan Qayyum; Shari Bolen; Nisa Maruthur; Leonard Feldman; Lisa M Wilson; Spyridon S Marinopoulos; Padmini Ranasinghe; Muhammed Amer; Eric B Bass Journal: Ann Intern Med Date: 2008-09-15 Impact factor: 25.391
Authors: Wenying Yang; Xiaoming Zhuang; Yukun Li; Qing Wang; Rongwen Bian; Jianguo Shen; Eva Hammerby; Li Yang Journal: Health Qual Life Outcomes Date: 2014-11-26 Impact factor: 3.186