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Health Economic Benefits and Quality of Life During Improved Glycemic Control in Patients With Type 2 Diabetes Mellitus: A Randomized, Controlled, Double-Blind Trial

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 typ...

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Published in:JAMA : the journal of the American Medical Association 1998-11, Vol.280 (17), p.1490-1496
Main Authors: Testa, Marcia A, Simonson, Donald C
Format: Article
Language:English
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Summary: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], respectively; P
ISSN:0098-7484
1538-3598
DOI:10.1001/jama.280.17.1490