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Priscilla Hollander, MD, PhD; Dahong Yu, PhD; Hubert S. Chou, MD, PhD

Arch Intern Med. 2007;167(12):1284-1290.

Background  The objective was to compare the efficacy and safety of adding low-dose rosiglitazone (2 or 4 mg/d) to insulin therapy vs continued insulin monotherapy in patients with type 2 diabetes mellitus who were unable to achieve glycemic control with insulin therapy alone.

Methods  In this 24-week, double-blind study, 630 individuals with type 2 diabetes mellitus that was inadequately controlled with insulin therapy alone were randomized to treatment with rosiglitazone (2 or 4 mg/d) or placebo in combination with ongoing insulin therapy. The dosage of insulin therapy could be adjusted at the investigator's discretion if required for hypoglycemia or additional glycemic control.

Results  The addition of rosiglitazone (2 or 4 mg/d) to insulin therapy significantly decreased mean glycated hemoglobin concentrations compared with placebo plus insulin (–0.3% [P = .02] and –0.4% [P<.001]) and compared with baseline (–0.6% and –0.8% [both P<.001]) after 24 weeks. The addition of 2 or 4 mg/d of rosiglitazone significantly decreased the C-reactive protein level (vs baseline: –22.0% [P<.001] and –34.2% [P<.001]; vs placebo: –22.2% [P = .003] and –32.0% [P<.001]) and fibrinogen (vs baseline: –10.5% and –12.0% [both P<.001]; vs placebo: –7.9% [P = .002] and –7.6% [P = .004]), while 4 mg/d of rosiglitazone significantly reduced matrix metalloproteinase 9 levels (vs baseline: –17.1% [P = .007]; vs placebo: –23.3% [P<.001]). The adverse event profile, including incidence of hypoglycemia and edema, was similar between treatment groups, and most adverse events were mild to moderate in intensity.

Conclusions  The addition of low-dose rosiglitazone to insulin therapy is an effective and well-tolerated treatment option for patients with type 2 diabetes mellitus who continue to have poor glycemic control despite administration of exogenous insulin as monotherapy.

Trial Registration  clinicaltrials.gov Identifier: NCT00054782

Author Affiliations: Endocrinology Center, Baylor University Medical Center, Dallas, Tex (Dr Hollander); and Clinical Development Group, Cardiovascular and Metabolic Medicine Development Center, GlaxoSmithKline, King of Prussia, Pa (Drs Yu and Chou).

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