STUDY OBJECTIVE: To evaluate the long-term safety and efficacy of glyburide versus pioglitazone in patients with a recent diagnosis of type 2 diabetes mellitus. DESIGN: Prospective, randomized, multicenter, double-blind trial with a 16-week titration period and a 40-week maintenance period. SETTING: Sixty-five investigative sites in the United States and Puerto Rico. PATIENTS: Five hundred two subjects with a recent diagnosis of type 2 diabetes that was unsuccessfully treated with diet and exercise were randomly assigned to study treatment. Of the 251 patients in each treatment group, 128 (51.0%) glyburide-treated patients and 134 (53.4%) pioglitazone-treated patients completed the study. INTERVENTIONS: Dosages of randomly assigned glyburide and pioglitazone were titrated every 4 weeks for 16 weeks in 5-mg/day and 15-mg/day increments, respectively, until a fasting plasma glucose level between 69 and 141 mg/dl was achieved. The optimized regimen was maintained during the subsequent 40-week double-blind phase. MEASUREMENTS AND MAIN RESULTS: At week 56, glyburide and pioglitazone improved glucose control comparably (change in hemoglobin A(1c) -2.02% and -2.07%, respectively, p=0.669). Withdrawal due to lack of efficacy or adverse events occurred more frequently with glyburide (20.8%) than pioglitazone (12.8%, p<0.032). Significantly higher percentages of glyburide- than pioglitazone-treated patients had a hypoglycemic (24.3% vs 4.4%, p=0.0001) or cardiac (8.8% vs 4.4%, p=0.0478) event. Edema (4.8% vs 7.9%, p=0.1443) and weight gain (4.4% vs 4.0%, p=0.8238) did not differ significantly between the glyburide and pioglitazone groups. Only a few patients discontinued study drug because of weight gain (one glyburide, one pioglitazone), edema (one pioglitazone), or a cardiac event (two glyburide). CONCLUSION: With long-term treatment, both glyburide and pioglitazone resulted in comparable glycemic control; however, pioglitazone was associated with less hypoglycemia and fewer withdrawals due to lack of efficacy or adverse events.
RCT Entities:
STUDY OBJECTIVE: To evaluate the long-term safety and efficacy of glyburide versus pioglitazone in patients with a recent diagnosis of type 2 diabetes mellitus. DESIGN: Prospective, randomized, multicenter, double-blind trial with a 16-week titration period and a 40-week maintenance period. SETTING: Sixty-five investigative sites in the United States and Puerto Rico. PATIENTS: Five hundred two subjects with a recent diagnosis of type 2 diabetes that was unsuccessfully treated with diet and exercise were randomly assigned to study treatment. Of the 251 patients in each treatment group, 128 (51.0%) glyburide-treated patients and 134 (53.4%) pioglitazone-treated patients completed the study. INTERVENTIONS: Dosages of randomly assigned glyburide and pioglitazone were titrated every 4 weeks for 16 weeks in 5-mg/day and 15-mg/day increments, respectively, until a fasting plasma glucose level between 69 and 141 mg/dl was achieved. The optimized regimen was maintained during the subsequent 40-week double-blind phase. MEASUREMENTS AND MAIN RESULTS: At week 56, glyburide and pioglitazone improved glucose control comparably (change in hemoglobin A(1c) -2.02% and -2.07%, respectively, p=0.669). Withdrawal due to lack of efficacy or adverse events occurred more frequently with glyburide (20.8%) than pioglitazone (12.8%, p<0.032). Significantly higher percentages of glyburide- than pioglitazone-treated patients had a hypoglycemic (24.3% vs 4.4%, p=0.0001) or cardiac (8.8% vs 4.4%, p=0.0478) event. Edema (4.8% vs 7.9%, p=0.1443) and weight gain (4.4% vs 4.0%, p=0.8238) did not differ significantly between the glyburide and pioglitazone groups. Only a few patients discontinued study drug because of weight gain (one glyburide, one pioglitazone), edema (one pioglitazone), or a cardiac event (two glyburide). CONCLUSION: With long-term treatment, both glyburide and pioglitazone resulted in comparable glycemic control; however, pioglitazone was associated with less hypoglycemia and fewer withdrawals due to lack of efficacy or adverse events.
Authors: A Avogaro; M Federici; J Betteridge; R Bonadonna; I W Campbell; G H Schernthaner; B Staels; E Farinaro; G Crepaldi Journal: J Endocrinol Invest Date: 2011-11 Impact factor: 4.256
Authors: David E Kemp; Faramarz Ismail-Beigi; Stephen J Ganocy; Carla Conroy; Keming Gao; Sarah Obral; Elizabeth Fein; Robert L Findling; Joseph R Calabrese Journal: J Affect Disord Date: 2011-07-22 Impact factor: 4.839
Authors: Mahmoud Ibrahim; Megahed Abu Al Magd; Firas A Annabi; Samir Assaad-Khalil; Ebtesam M Ba-Essa; Ibtihal Fahdil; Sehnaz Karadeniz; Terry Meriden; Aly A Misha'l; Paolo Pozzilli; Samad Shera; Abraham Thomas; Suhad Bahijri; Jaakko Tuomilehto; Temel Yilmaz; Guillermo E Umpierrez Journal: BMJ Open Diabetes Res Care Date: 2015-06-16