TY - JOUR
T1 - Effect of troglitazone in insulin-treated patients with type II diabetes mellitus
AU - Schwartz, Sherwyn
AU - Raskin, Philip
AU - Fonseca, Vivian
AU - Graveline, Jane F.
PY - 1998/3/26
Y1 - 1998/3/26
N2 - Background: Troglitazone is a new oral antidiabetic drug that increases the sensitivity of peripheral tissues to insulin. It may therefore increase the efficacy of exogenous insulin in patients with insulin-resistant diabetes mellitus. Methods: We studied the effect of troglitazone or placebo in 350 patients with poorly controlled non-insulin-dependent (type II) diabetes mellitus (glycosylated hemoglobin values, 8 to 12 percent; normal, 4.3 to 6.1 percent) despite therapy with at least 30 U of insulin daily. The patients were randomly assigned to receive 200 mg of troglitazone (116 patients), 600 mg of troglitazone (116 patients), or placebo (118 patients) daily for 26 weeks. Insulin doses were not increased and were reduced only to prevent hypoglycemia. Glycosylated hemoglobin, serum glucose while fasting, serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglycerides were measured 5 times during an 8- week base-line period and 10 times during the 26-week treatment period. Daily insulin doses were recorded during both periods. Results: Ninety percent of the patients completed the study. The adjusted mean glycosylated hemoglobin values decreased by 0.8 and 1.4 percentage points, respectively, in the group given 200 mg of troglitazone and the group given 600 mg of troglitazone, and fasting serum glucose concentrations decreased by 35 and 49 mg per deciliter (1.9 and 2.7 mmol per liter), respectively, despite decreases in the insulin dose of 11 percent and 29 percent (P<0.001 for all comparisons with the placebo group). Serum total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol concentrations increased slightly and serum triglyceride concentrations decreased slightly in the troglitazone- treated patients. Conclusions: When given in conjunction with insulin, troglitazone improves glycemic control in patients with type II diabetes mellitus.
AB - Background: Troglitazone is a new oral antidiabetic drug that increases the sensitivity of peripheral tissues to insulin. It may therefore increase the efficacy of exogenous insulin in patients with insulin-resistant diabetes mellitus. Methods: We studied the effect of troglitazone or placebo in 350 patients with poorly controlled non-insulin-dependent (type II) diabetes mellitus (glycosylated hemoglobin values, 8 to 12 percent; normal, 4.3 to 6.1 percent) despite therapy with at least 30 U of insulin daily. The patients were randomly assigned to receive 200 mg of troglitazone (116 patients), 600 mg of troglitazone (116 patients), or placebo (118 patients) daily for 26 weeks. Insulin doses were not increased and were reduced only to prevent hypoglycemia. Glycosylated hemoglobin, serum glucose while fasting, serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglycerides were measured 5 times during an 8- week base-line period and 10 times during the 26-week treatment period. Daily insulin doses were recorded during both periods. Results: Ninety percent of the patients completed the study. The adjusted mean glycosylated hemoglobin values decreased by 0.8 and 1.4 percentage points, respectively, in the group given 200 mg of troglitazone and the group given 600 mg of troglitazone, and fasting serum glucose concentrations decreased by 35 and 49 mg per deciliter (1.9 and 2.7 mmol per liter), respectively, despite decreases in the insulin dose of 11 percent and 29 percent (P<0.001 for all comparisons with the placebo group). Serum total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol concentrations increased slightly and serum triglyceride concentrations decreased slightly in the troglitazone- treated patients. Conclusions: When given in conjunction with insulin, troglitazone improves glycemic control in patients with type II diabetes mellitus.
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U2 - 10.1056/NEJM199803263381302
DO - 10.1056/NEJM199803263381302
M3 - Article
C2 - 9516220
AN - SCOPUS:0032568310
SN - 0028-4793
VL - 338
SP - 861
EP - 866
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 13
ER -