The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Export

@article{citeulike:1580614, abstract = {OBJECTIVE: To compare the abilities and associated hypoglycemia risks of insulin glargine and human NPH insulin added to oral therapy of type 2 diabetes to achieve 7\% HbA(1c). RESEARCH DESIGN AND METHODS: In a randomized, open-label, parallel, 24-week multicenter trial, 756 overweight men and women with inadequate glycemic control (HbA(1c) >7.5\%) on one or two oral agents continued prestudy oral agents and received bedtime glargine or NPH once daily, titrated using a simple algorithm seeking a target fasting plasma glucose (FPG) <or=100 mg/dl (5.5 mmol/l). Outcome measures were FPG, HbA(1c), hypoglycemia, and percentage of patients reaching HbA(1c) <or=7\% without documented nocturnal hypoglycemia. RESULTS: Mean FPG at end point was similar with glargine and NPH (117 vs. 120 mg/dl [6.5 vs. 6.7 mmol/l]), as was HbA(1c) (6.96 vs. 6.97\%). A majority of patients ( approximately 60\%) attained HbA(1c) <or=7\% with each insulin type. However, nearly 25\% more patients attained this without documented nocturnal hypoglycemia (<or=72 mg/dl [4.0 mmol/l]) with glargine (33.2 vs. 26.7\%, P < 0.05). Moreover, rates of other categories of symptomatic hypoglycemia were 21-48\% lower with glargine. CONCLUSIONS: Systematically titrating bedtime basal insulin added to oral therapy can safely achieve 7\% HbA(1c) in a majority of overweight patients with type 2 diabetes with HbA(1c) between 7.5 and 10.0\% on oral agents alone. In doing this, glargine causes significantly less nocturnal hypoglycemia than NPH, thus reducing a leading barrier to initiating insulin. This simple regimen may facilitate earlier and effective insulin use in routine medical practice, improving achievement of recommended standards of diabetes care.}, address = {Oregon Health and Science University, Portland, Oregon 97201, USA. riddlem@ohsu.edu}, author = {Riddle, Matthew C. and Rosenstock, Julio and Gerich, John and {Insulin Glargine 4002 Study Investigators}}, citeulike-article-id = {1580614}, citeulike-linkout-0 = {http://dx.doi.org/10.2337/diacare.26.11.3080}, citeulike-linkout-1 = {http://care.diabetesjournals.org/content/26/11/3080.abstract}, citeulike-linkout-2 = {http://care.diabetesjournals.org/content/26/11/3080.full.pdf}, citeulike-linkout-3 = {http://view.ncbi.nlm.nih.gov/pubmed/14578243}, citeulike-linkout-4 = {http://www.hubmed.org/display.cgi?uids=14578243}, doi = {10.2337/diacare.26.11.3080}, issn = {0149-5992}, journal = {Diabetes care}, keywords = {combination, diabetes, glargine, hypoglycemia, insulin, nph, oral, target}, month = {November}, number = {11}, pages = {3080--3086}, posted-at = {2009-09-26 06:45:34}, priority = {0}, title = {The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients.}, url = {http://dx.doi.org/10.2337/diacare.26.11.3080}, volume = {26}, year = {2003} }

TY - JOUR ID - citeulike:1580614 L3 - citeulike-article-id:1580614 N2 - OBJECTIVE: To compare the abilities and associated hypoglycemia risks of insulin glargine and human NPH insulin added to oral therapy of type 2 diabetes to achieve 7% HbA(1c). RESEARCH DESIGN AND METHODS: In a randomized, open-label, parallel, 24-week multicenter trial, 756 overweight men and women with inadequate glycemic control (HbA(1c) >7.5%) on one or two oral agents continued prestudy oral agents and received bedtime glargine or NPH once daily, titrated using a simple algorithm seeking a target fasting plasma glucose (FPG) <or=100 mg/dl (5.5 mmol/l). Outcome measures were FPG, HbA(1c), hypoglycemia, and percentage of patients reaching HbA(1c) <or=7% without documented nocturnal hypoglycemia. RESULTS: Mean FPG at end point was similar with glargine and NPH (117 vs. 120 mg/dl [6.5 vs. 6.7 mmol/l]), as was HbA(1c) (6.96 vs. 6.97%). A majority of patients ( approximately 60%) attained HbA(1c) <or=7% with each insulin type. However, nearly 25% more patients attained this without documented nocturnal hypoglycemia (<or=72 mg/dl [4.0 mmol/l]) with glargine (33.2 vs. 26.7%, P < 0.05). Moreover, rates of other categories of symptomatic hypoglycemia were 21-48% lower with glargine. CONCLUSIONS: Systematically titrating bedtime basal insulin added to oral therapy can safely achieve 7% HbA(1c) in a majority of overweight patients with type 2 diabetes with HbA(1c) between 7.5 and 10.0% on oral agents alone. In doing this, glargine causes significantly less nocturnal hypoglycemia than NPH, thus reducing a leading barrier to initiating insulin. This simple regimen may facilitate earlier and effective insulin use in routine medical practice, improving achievement of recommended standards of diabetes care. IS - 11 JF - Diabetes care SN - 0149-5992 AD - Oregon Health and Science University, Portland, Oregon 97201, USA. riddlem@ohsu.edu EP - 3086 TI - The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. VL - 26 SP - 3080 KW - combination KW - diabetes KW - glargine KW - hypoglycemia KW - insulin KW - nph KW - oral KW - target AU - Riddle, Matthew AU - Rosenstock, Julio AU - Gerich, John PY - 2003/11// UR - http://dx.doi.org/10.2337/diacare.26.11.3080 ER -