Last Updated: 2001-08-02 16:13:23 EDT (Reuters Health)
WESTPORT, CT (Reuters Health) – The addition of rosiglitazone prompts improvement in glycemic control in type 2 diabetics inadequately controlled on insulin alone, according to researchers from the University of Texas Southwestern Medical Center at Dallas and other centers.
Reporting in the July issue of Diabetes Care, Dr. Philip Raskin and colleagues note that rosiglitazone has been shown to improve insulin action in isolated tissue and to improve glycemic control in certain patients with type 2 diabetes.
To gain further information on the efficacy and safety of the agent, the researchers conducted a double-blind study of 319 type 2 diabetics who were poorly controlled on insulin monotherapy.
Patients underwent twice-daily insulin treatment and were randomized to receive additional therapy with rosiglitazone 4 or 8 mg daily or placebo. One aim of the study was "to keep insulin dosage constant, unless dose reduction was required to avoid hypoglycemia."
After 26 weeks, no change was seen in placebo patients, but those in both treatment groups had significantly improved glycemic control.
Patients in the 8-mg group showed a mean reduction in glycosylated hemoglobin A (HbA1c) over baseline of 1.2%, despite a 12% reduction of insulin dosage. More than 50% of patients in the 8-mg group showed an HbA1c reduction of at least 1%. There were no significant changes in cholesterol ratios associated with treatment, and serious adverse events did not differ among groups.
The researchers caution that the agent may take 3 months or more to achieve a maximal effect on HbA1c and "prescribers should be aware of the gradual onset of action."
Diabetes Care 2001;24:1226-1232.
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