AIMS: To compare the efficacy and safety of these two agents and the impact on surrogate markers related to diabetic complications in Japanese type 2 diabetic patients. METHODS: In a multicenter, open-label trial, 130 patients whose diabetes had been inadequately controlled (HbA1c, 6.9-9.5%) withmetformin and/or sulphonylurea were randomly assigned to a sitagliptin group (50 mg/day) or a pioglitazone group (15 mg/day) and were followed up for 24 weeks. At 16 weeks, if the patient's HbA1c level was ≥6.5%, the dose of sitagliptin or pioglitazone was increased up to 100 or 30 mg/day, respectively. Main outcome measure was the difference in the mean changes in the HbA1c level from baseline at 24 weeks between these two groups. RESULTS: Of the 130 patients who were enrolled, 115 subjects (sitagliptin group: 58 patients, pioglitazonegroup: 57 patients) completed this trial. At 0 weeks, the mean HbA1c level was 7.47 ± 0.66% in the sitagliptin group and 7.40 ± 0.61% in the pioglitazone group. At 24 weeks, the mean changes in the HbA1c level from baseline were -0.86 ± 0.63% versus -0.58 ± 0.68% (p = 0.024). Hypoglycaemia (2 patients, 3.4% vs. 2 patients, 3.5%), gastrointestinal symptoms (3 patients, 5.2% vs. 1 patient, 1.8%) and pretibial oedema (0 patients, 0% vs. 39 patients, 68.4%, p < 0.001) were observed for 24 weeks. CONCLUSIONS:Sitagliptin was not only more tolerable, but also more effective than pioglitazone in Japanese type 2 diabetic patients who had been treated withmetformin and/or sulphonylurea.
RCT Entities:
AIMS: To compare the efficacy and safety of these two agents and the impact on surrogate markers related to diabetic complications in Japanese type 2 diabeticpatients. METHODS: In a multicenter, open-label trial, 130 patients whose diabetes had been inadequately controlled (HbA1c, 6.9-9.5%) with metformin and/or sulphonylurea were randomly assigned to a sitagliptin group (50 mg/day) or a pioglitazone group (15 mg/day) and were followed up for 24 weeks. At 16 weeks, if the patient's HbA1c level was ≥6.5%, the dose of sitagliptin or pioglitazone was increased up to 100 or 30 mg/day, respectively. Main outcome measure was the difference in the mean changes in the HbA1c level from baseline at 24 weeks between these two groups. RESULTS: Of the 130 patients who were enrolled, 115 subjects (sitagliptin group: 58 patients, pioglitazone group: 57 patients) completed this trial. At 0 weeks, the mean HbA1c level was 7.47 ± 0.66% in the sitagliptin group and 7.40 ± 0.61% in the pioglitazone group. At 24 weeks, the mean changes in the HbA1c level from baseline were -0.86 ± 0.63% versus -0.58 ± 0.68% (p = 0.024). Hypoglycaemia (2 patients, 3.4% vs. 2 patients, 3.5%), gastrointestinal symptoms (3 patients, 5.2% vs. 1 patient, 1.8%) and pretibial oedema (0 patients, 0% vs. 39 patients, 68.4%, p < 0.001) were observed for 24 weeks. CONCLUSIONS:Sitagliptin was not only more tolerable, but also more effective than pioglitazone in Japanese type 2 diabeticpatients who had been treated with metformin and/or sulphonylurea.
Authors: Martin C S Wong; Harry H X Wang; Mandy W M Kwan; Daisy D X Zhang; Kirin Q L Liu; Sky W M Chan; Carmen K M Fan; Brian C Y Fong; Shannon T S Li; Sian M Griffiths Journal: PLoS One Date: 2014-03-10 Impact factor: 3.240
Authors: Jong Ho Kim; Sang Soo Kim; Hong Sun Baek; In Kyu Lee; Dong Jin Chung; Ho Sang Sohn; Hak Yeon Bae; Mi Kyung Kim; Jeong Hyun Park; Young Sik Choi; Young Il Kim; Jong Ryeal Hahm; Chang Won Lee; Sung Rae Jo; Mi Kyung Park; Kwang Jae Lee; In Joo Kim Journal: Diabetes Metab J Date: 2016-04-21 Impact factor: 5.376