Once- and twice-daily dosing with rosiglitazone improves glycemic control in patients with type 2 diabetes.
OBJECTIVE
To determine the efficacy of rosiglitazone compared with placebo in reducing hyperglycemia.


METHODS
After a 4-week placebo run-in period, 959 patients were randomized to placebo or rosiglitazone (total daily dose 4 or 8 mg) for 26 weeks. The primary measure of efficacy was change in the HbA1c concentration.


RESULTS
Rosiglitazone produced dosage-dependent reductions in HbA1c of 0.8, 0.9, 1.1, and 1.5% in the 4 mg o.d., 2 mg b.i.d., 8 mg o.d., and 4 mg b.i.d. groups, respectively, compared with placebo. Clinically significant decreases from baseline in HbA1c were observed in drug-naive patients at all rosiglitazone doses and in patients previously treated with oral monotherapy at rosiglitazone 8 mg o.d. and 4 mg b.i.d. Clinically significant decreases from baseline in HbA1c were also observed with rosiglitazone 4 mg b.i.d. in patients previously treated with combination oral therapy. Approximately 33% of drug-naive patients treated with rosiglitazone achieved HbA1c < or =7% at study end. The proportions of patients with at least one adverse event were comparable among the rosiglitazone and placebo groups. There was no evidence of hepatotoxicity in any treatment group. There were statistically significant increases in weight and serum lipids in all rosiglitazone treatment groups compared with placebo. For LDL and HDL cholesterol, the observed increase appeared to be dose related.


CONCLUSIONS
Rosiglitazone at total daily doses of 4 and 8 mg significantly improved glycemic control in patients with type 2 diabetes and was well tolerated.
Phillips
L S
LS
Division of Endocrinology, Emory University School of Medicine, Atlanta, Georgia 30322, USA. medlsp@emory.edu
Grunberger
G
G
Miller
E
E
Patwardhan
R
R
Rappaport
E B
EB
Salzman
A
A
D000368:Aged; D001786:Blood Glucose / Q000032:analysis / Q000378:metabolism*; D002096:C-Peptide / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005215:Fasting; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D007333:Insulin Resistance; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D010919:Placebos; D000077154:Rosiglitazone; D013844:Thiazoles / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D045162:Thiazolidinediones; D014280:Triglycerides / Q000097:blood
D001786:Blood Glucose; D002096:C-Peptide; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008055:Lipids; D010919:Placebos; D000077154:Rosiglitazone; D013844:Thiazoles; D045162:Thiazolidinediones; D014280:Triglycerides