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Rosiglitazone in Type 2 diabetes mellitus: an evaluation in British Indo‐Asian patients
Author(s) -
Barnett A. H.,
Grant P. J.,
Hitman G. A.,
Mather H.,
Pawa M.,
Robertson L.,
Trelfa A.
Publication year - 2003
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1046/j.1464-5491.2003.00925.x
Subject(s) - medicine , rosiglitazone , placebo , type 2 diabetes , type 2 diabetes mellitus , diabetes mellitus , endocrinology , gastroenterology , insulin , confidence interval , clinical endpoint , randomized controlled trial , alternative medicine , pathology
Aims To evaluate the effectiveness of rosiglitazone in reducing hyperglycaemia in patients with Type 2 diabetes mellitus (DM) of Indo‐Asian origin taking concurrent sulphonylurea therapy. Methods A randomized, double‐blind, placebo‐controlled study of 26 weeks’ duration at 31 primary and secondary care centres in areas of the UK with a high Indo‐Asian population, including 177 patients aged 28–78 years. Rosiglitazone 8 mg/day or matching placebo was added to existing sulphonylurea therapy. The primary endpoint was change from baseline in glycosylated haemoglobin A 1c (HbA 1c ) at week 26. Results The mean changes in HbA 1c were −1.16% with rosiglitazone (baseline 9.21%) and +0.26% with placebo (baseline 9.06%) (treatment difference P < 0.001; 95% confidence interval (CI) −1.81, −1.08). HbA 1c fell below 8% in 55% and 19% of patients, respectively (treatment difference P < 0.001; 95% CI 0.22, 0.51). The greatest improvements occurred in patients whose glycaemic control was initially poor. Improvements in homeostasis model assessment of insulin sensitivity and pancreatic β‐cell function with rosiglitazone were not accompanied by a change in plasma insulin or C‐peptide after 26 weeks. Free fatty acids fell by 0.09 mmol/l with rosiglitazone and increased by 0.03 mmol/l with placebo (treatment difference P < 0.001; 95% CI −0.19, −0.07). Conclusion Rosiglitazone improved insulin sensitivity, pancreatic β‐cell function, and glycaemic control in Indo‐Asian patients with Type 2 DM who are at greater risk of the complications of Type 2 DM than other ethnic groups. Diabet. Med. 20, 387–393 (2003)