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

Diabet Med. 2003 May;20(5):387-93. doi: 10.1046/j.1464-5491.2003.00925.x.

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 beta-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 beta-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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Asia / ethnology
  • Blood Glucose / drug effects
  • Blood Glucose / metabolism*
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / ethnology
  • Drug Therapy, Combination
  • Fasting
  • Female
  • Glycated Hemoglobin A / drug effects
  • Humans
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / therapeutic use*
  • Male
  • Middle Aged
  • Placebos
  • Rosiglitazone
  • Sensitivity and Specificity
  • Thiazoles / adverse effects
  • Thiazoles / therapeutic use*
  • Thiazolidinediones*
  • Treatment Outcome

Substances

  • Blood Glucose
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Placebos
  • Thiazoles
  • Thiazolidinediones
  • Rosiglitazone