Résumé :
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[BDSP. Notice produite par INIST 7B1sR0x3. Diffusion soumise à autorisation]. Context. - Although the long-term health benefits of good glycemic control in patients with diabetes are well documented, shorter-term quality of life (QOL) and economic savings generally have been reported to be minimal or absent. Objective. - To examine short-term outcomes of glycemic control in type 2 diabetes mellitus (DM). Design. - Double-blind, randomized, placebo-controlled, parallel trial. Setting. - Sixty-two sites in the United States. Participants. - A total of 569 male and female volunteers with type 2 DM. Intervention. - After a 3-week, single-blind placebo-washout period, participants were randomized to diet and titration with either 5 to 20 mg of glipizide gastrointestinal therapeutic system (GITS) (n=377) or placebo (n=192) for 12 weeks. Main Outcome Measures. - Change from baseline in glucose and hemoglobin A1c (HbA1c) levels and symptom distress, QOL, and health economic indicators by questionnaires and diaries. Results. - After 12 weeks, mean ( SE) HbA1c and fasting blood glucose levels decreased with active therapy (glipizide GITS) vs placebo (7.5% 0.1% vs 9.3% 0.1% and 7.0 0.1 mmol/L [126 2 mg/dL] vs 9.3 0.2 mmol/L [168 4 mg/dL], respectiveiy ; P<. 001). Quality-of-life treatment differences (SD units) for symptom distress (+0.59 ; P<. 001), general perceived health (+0.36 ; P=004), cognitive functioning (+0.34 ; P=005), and the overall visual analog scale (VAS) (+0.24 ; P=04) were significantly more favorable for active therapy. (...)
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