Clinical studyGlycemic control with Glyburide/Metformin tablets in combination with rosiglitazone in patients with type 2 diabetes: a randomized, double-blind trial☆
Section snippets
Study sample
The study was carried out at 61 centers in the United States. All patients gave written informed consent before participating. Patients with inadequately controlled type 2 diabetes (glycosylated hemoglobin [HbA1C] levels >7.0% and ≤10.0%) were enrolled if they were between 20 and 78 years of age and had a body mass index between 23 and 40 kg/m2 (inclusive). All patients were on a stable regimen with an oral antidiabetic agent for 8 weeks before screening. For the lead-in phase, the inclusion
Results
Of the 453 patients enrolled, 365 who were receiving stable doses of glyburide/metformin were assigned randomly to 24 weeks of double-blind treatment with either rosiglitazone (n = 181) or placebo (n = 184) (Figure 1). Forty-four of the 88 patients who were excluded during the lead-in phase did not meet randomization criteria. A total of 261 patients (72%) completed the 24-week study.
The mean (±SD) age of the 365 randomly assigned patients was 57 ± 9 years (Table 1). Most were white (74% [n =
Discussion
Because type 2 diabetes is a chronic and progressive disease, most patients eventually require a combination pharmacologic approach to achieve or maintain glycemic control (2). In the earlier stages of disease when monotherapy fails, the combination of two or three oral agents may suffice; if glycemic control still cannot be achieved, insulin therapy may be required 1, 5. Addition of metformin to a failed sulfonylurea monotherapy regimen, or vice versa, often improves glucose control. Further
Acknowledgements
The contributions of the patients and the clinic staff to the success of this study are greatly appreciated.
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2012, Endocrine PracticeCitation Excerpt :In addition to metformin, other widely used agents in the U.S. to treat T2DM fall into two main categories: those that increase plasma insulin levels (by either providing an exogenous source of insulin or by augmenting the beta cell insulin secretory capacity through a variety of different mechanisms e.g., sulfonylureas, meglitinides, glucagon-like peptide-1 analogs or mimetics [GLP-1 analogs], or dipeptidyl peptidase-4 inhibitors [DPP4Is]), although GLP-1 analogs and DPP4Is also act to inhibit hyperglucagonemia to a certain extent, and those that increase insulin sensitivity by acting at the muscle and/or liver), (e.g., pioglitazone). Yet, many T2DM patients continue to have uncontrolled hyperglycemia, even with double or triple antihyperglycemic therapy (8,9). Additional anti-diabetes agents that act through different but complimentary mechanisms would be useful in managing hyperglycemia, especially postprandially.
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2011, Diabetes Research and Clinical PracticeCitation Excerpt :Infact, the mean weight of subjects was decreased by 1.7 kg over 6 months (p < 0.0001), and nearly half the subjects (46.2%) lost 2 kg of weight. These results are in contrast to those reported previously that treatment with rosiglitazone is associated with weight gain [35,45]. Furthermore, recent results from a fat distribution study in patients with T2D suggest that weight gain with rosiglitazone is associated with an increase in subcutaneous fat and not visceral fat, which is more closely associated with cardiovascular (CV) risk [26], whereas this is likely to be due to both an increase in subcutaneous and higher risk visceral fat [46].
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This study was supported by a grant from the Bristol-Myers Squibb Pharmaceutical Research Institute, Princeton, New Jersey. Dr. Dailey has received grant support from Bristol-Myers Squibb and has served on its Speakers Bureau and as an occasional consultant.