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Rosiglitazone RECORD study: glucose control outcomes at 18 months
Author(s) -
Home P. D.,
Jones N. P.,
Pocock S. J.,
BeckNielsen H.,
Gomis R.,
Hanefeld M.,
Komajda M.,
Curtis P.
Publication year - 2007
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 - 10.1111/j.1464-5491.2007.02160.x
Subject(s) - rosiglitazone , metformin , medicine , endocrinology , type 2 diabetes , diabetes mellitus
Aims To compare glucose control over 18 months between rosiglitazone oral combination therapy and combination metformin and sulphonylurea in people with Type 2 diabetes. Methods RECORD, a multicentre, parallel‐group study of cardiovascular outcomes, enrolled people with an HbA 1c of 7.1–9.0% on maximum doses of metformin or sulphonylurea. If on metformin they were randomized to add‐on rosiglitazone or sulphonylurea (open label) and if on sulphonylurea to rosiglitazone or metformin. HbA 1c was managed to ≤ 7.0% by dose titration. A prospectively defined analysis of glycaemic control on the first 1122 participants is reported here, with a primary outcome assessed against a non‐inferiority margin for HbA 1c of 0.4%. Results At 18 months, HbA 1c reduction on background metformin was similar with rosiglitazone and sulphonylurea [difference 0.07 (95% CI −0.09, 0.23)%], as was the change when rosiglitazone or metformin was added to sulphonylurea [0.06 (−0.09, 0.20)%]. At 6 months, the effect on HbA 1c was greater with add‐on sulphonylurea, but was similar whether sulphonylurea was added to rosiglitazone or metformin. Differences in fasting plasma glucose were not statistically significant at 18 months [rosiglitazone vs. sulphonylurea −0.36 (−0.74, 0.02) mmol/l, rosiglitazone vs. metformin −0.34 (−0.73, 0.05) mmol/l]. Increased homeostasis model assessment insulin sensitivity and reduced C‐reactive protein were greater with rosiglitazone than metformin or sulphonylurea (all P ≤ 0.001). Body weight was significantly increased with rosiglitazone compared with sulphonylurea [difference 1.2 (0.4, 2.0) kg, P = 0.003] and metformin [difference 4.3 (3.6, 5.1) kg, P < 0.001]. Conclusions In people with diabetes, rosiglitazone in combination with metformin or sulphonylurea was demonstrated to be non‐inferior to the standard combination of metformin + sulphonylurea in lowering HbA 1c over 18 months, and produces greater improvements in C‐reactive protein and basal insulin sensitivity but is also associated with greater weight gain.