This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on Web of Science (4)  • Contact me when this article is cited  Related Content  • Related letters  • Similar articles in this journal  Topic Collections  • Drug Therapy, Other  • Diabetes Mellitus  • Alert me on articles by topic  Social Bookmarking   What's this?

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).

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

RELATED LETTERS

Cardiovascular Safety of Low-Dose Rosiglitazone
Nasser Mikhail
Arch Intern Med. 2008;168(1):109.
EXTRACT | FULL TEXT  

Low-Dose Rosiglitazone in Patients With Type 2 Diabetes Mellitus Requiring Insulin Therapy
Cesar A. Lopez and Balavenkatesh Kanna
Arch Intern Med. 2008;168(5):548.
EXTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Rosiglitazone and pioglitazone in the treatment of diabetes mellitus
Odom et al.
Am J Health Syst Pharm 2008;65:1846-1850.
FULL TEXT  

Low-Dose Rosiglitazone in Patients With Type 2 Diabetes Mellitus Requiring Insulin Therapy
Lopez and Kanna
Arch Intern Med 2008;168:548-548.
FULL TEXT  

Cardiovascular Safety of Low-Dose Rosiglitazone
Mikhail
Arch Intern Med 2008;168:109-109.
FULL TEXT  

Rosiglitazone Reduces Liver Fat and Insulin Requirements and Improves Hepatic Insulin Sensitivity and Glycemic Control in Patients with Type 2 Diabetes Requiring High Insulin Doses
Juurinen et al.
J. Clin. Endocrinol. Metab. 2008;93:118-124.
ABSTRACT | FULL TEXT  

Anti-Diabetes and Anti-Obesity Medications: Effects on Weight in People With Diabetes
Hollander
Diabetes Spectr. 2007;20:159-165.
ABSTRACT | FULL TEXT