Document Detail


Addition of rosiglitazone to existing sulfonylurea treatment in chinese patients with type 2 diabetes and exposure to hepatitis B or C.
MedLine Citation:
PMID:  12725705     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The effects of adding rosiglitazone to existing sulfonylurea (SU) treatment have not previously been studied in Chinese patients with type 2 diabetes and no known pre-existing hepatic impairment. Patients were randomized to receive rosiglitazone 2 mg twice daily (R4 + SU) or 4 mg twice daily (R8 + SU) or placebo (SU + P) for 24 weeks in addition to existing SU treatment. Most patients were taking concomitant glibenclamide (34%) or gliclazide (25%). Changes in glycosylated hemoglobin (HbA(1c)), fasting plasma glucose (FPG), and plasma insulin concentrations were measured. Of the 530 patients enrolled (45% male, mean age 59 years), 105 were in the SU + P group, 215 in the R4 + SU group, and 210 in the R8 + SU group. The mean baseline HbA(1c) was 9.8%, and FPG was 183.8 mg/dL. Compared with placebo, addition of rosiglitazone (2 or 4 mg twice daily) produced significant decreases in mean HbA(1c) (1.04% and 1.44%, respectively; p < 0.0001) and FPG (21.6 and 36.0 mg/dL, respectively; p < 0.0001). There were statistically significant (p < 0.0001) reductions from baseline in insulin concentration of 23.3 and 30.4 pmol/L in the R4 + SU and R8 + SU groups, respectively. Despite the high prevalence of seropositivity for hepatitis B and/or C at baseline (56%), there was no evidence of hepatotoxicity. No clinically significant changes in routine hematology, biochemistry, or electrocardiogram were observed. The addition of rosiglitazone to SU produced clinically significant improvements in glycemic control in Chinese patients with type 2 diabetes. Rosiglitazone plus SU was well tolerated irrespective of hepatitis B and C serological status.
Authors:
X-X Zhu; C-Y Pan; G-W Li; H-L Shi; H Tian; W-Y Yang; J Jiang; X-C Sun; C Davies; W-H Chow
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Diabetes technology & therapeutics     Volume:  5     ISSN:  1520-9156     ISO Abbreviation:  Diabetes Technol. Ther.     Publication Date:  2003  
Date Detail:
Created Date:  2003-05-02     Completed Date:  2003-10-23     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  100889084     Medline TA:  Diabetes Technol Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  33-42     Citation Subset:  IM    
Affiliation:
Shanghai Huashan Hospital, Shanghai, China.
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MeSH Terms
Descriptor/Qualifier:
Adult
Asian Continental Ancestry Group
Blood Glucose / analysis
China
Diabetes Mellitus, Type 2 / drug therapy*
Double-Blind Method
Drug Therapy, Combination
Environmental Exposure*
Female
Gliclazide / therapeutic use
Glyburide / therapeutic use
Hemoglobin A, Glycosylated / drug effects,  metabolism
Hepatitis B / prevention & control*
Hepatitis C / prevention & control*
Humans
Hypoglycemic Agents / therapeutic use*
Insulin / blood
Male
Middle Aged
Sulfonylurea Compounds / therapeutic use*
Thiazoles / therapeutic use*
Thiazolidinediones*
Chemical
Reg. No./Substance:
0/Blood Glucose; 0/Hemoglobin A, Glycosylated; 0/Hypoglycemic Agents; 0/Sulfonylurea Compounds; 0/Thiazoles; 0/Thiazolidinediones; 10238-21-8/Glyburide; 11061-68-0/Insulin; 122320-73-4/rosiglitazone; 21187-98-4/Gliclazide
Comments/Corrections
Comment In:
Diabetes Technol Ther. 2003;5(1):43-4   [PMID:  12725706 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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