Rosiglitazone in Type 2 diabetes mellitus: an evaluation in British Indo‐Asian patients

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Abstract
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 A1c (HbA1c) at week 26. Results The mean changes in HbA1c 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). HbA1c 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)