A double-blind randomized study comparing the effects of continuing or not continuing rosiglitazone + metformin therapy when starting insulin therapy in people with type 2 diabetes

Home, P.D., Bailey, C.J., Donaldson, J., Chen, H. and Stewart, M.W. (2007). A double-blind randomized study comparing the effects of continuing or not continuing rosiglitazone + metformin therapy when starting insulin therapy in people with type 2 diabetes. Diabetic Medicine, 24 (6), pp. 618-625.

Abstract

Aims: To compare the efficacy and safety of either continuing or discontinuing rosiglitazone + metformin fixed-dose combination when starting insulin therapy in people with Type 2 diabetes inadequately controlled on oral therapy. Methods: In this 24-week double-blind study, 324 individuals with Type 2 diabetes inadequately controlled on maximum dose rosiglitazone + metformin therapy were randomly assigned to twice-daily premix insulin therapy (target pre-breakfast and pre-evening meal glucose ≤ 6.5 mmol/l) in addition to either rosiglitazone + metformin (8/2000 mg) or placebo. Results: Insulin dose at week 24 was significantly lower with rosiglitazone + metformin (33.5 ± 1.5 U/day, mean ± se) compared with placebo [59.0 ± 3.0 U/day; model-adjusted difference -26.6 (95% CI -37.7, -15,5) U/day, P < 0.001]. Despite this, there was greater improvement in glycaemic control [HbA 1c rosiglitazone + metformin vs. placebo 6.8 ± 0.1 vs. 7.5 ± 0.1%; difference -0.7 (-0.8, -0.5)%, P < 0.001] and more individuals achieved glycaemic targets (HbA1c < 7.0% 70 vs. 34%, P < 0.001). The proportion of individuals reporting at least one hypoglycaemic event during the last 12 weeks of treatment was similar in the two groups (rosiglitazone + metformin vs. placebo 25 vs. 27%). People receiving rosiglitazone + metformin in addition to insulin reported greater treatment satisfaction than those receiving insulin alone. Both treatment regimens were well tolerated but more participants had oedema [12 (7%) vs. 4 (3%)] and there was more weight gain [3.7 vs. 2.6 kg; difference 1.1 (0.2, 2.1) kg, P = 0.02] with rosiglitazone + metformin. Conclusions: Addition of insulin to rosiglitazone + metformin enabled more people to reach glycaemic targets with less insulin, and was generally well tolerated. © 2007 The Authors.

Publication DOI: https://doi.org/10.1111/j.1464-5491.2007.02141.x
Divisions: Life & Health Sciences > Biosciences
Life & Health Sciences
Life & Health Sciences > Applied Health Research Group
Additional Information: © 2007 The Authors. Journal compilation © 2007 Diabetes UK. Diabetic Medicine.Re‐use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation.
Uncontrolled Keywords: insulin,metformin,randomized controlled trial,thiazolidinediones,type 2 diabetes mellitus,Endocrinology,Internal Medicine,Endocrinology, Diabetes and Metabolism
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Related URLs: http://www.scopus.com/inward/record.url?scp=34249337380&partnerID=8YFLogxK (Scopus URL)
http://onlinelibrary.wiley.com/doi/10.1111/j.1464-5491.2007.02141.x/abstract (Publisher URL)
Published Date: 2007-06
Authors: Home, P.D.
Bailey, C.J. ( 0000-0002-6998-6811)
Donaldson, J.
Chen, H.
Stewart, M.W.

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