Effects of Colesevelam HCl, Rosiglitazone, or Sitagliptin on Glycemic Control and the Lipid Profile in Subjects With Type 2 Diabetes Inadequately Controlled on Metformin Monotherapy. Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists [Endocr Pract] Journal article | | Title | Effects of Colesevelam HCl, Rosiglitazone, or Sitagliptin on Glycemic Control and the Lipid Profile in Subjects With Type 2 Diabetes Inadequately Controlled on Metformin Monotherapy. | | Author(s) | Rigby SP, Handelsman Y, Lai YL, Abby SL, Tao B, Jones MR | | Institution | Primary Care Associates of Ohio, Kent, OH, USA. | | Source | Endocr Pract 2009 Sep 28.:1-34. | | Abstract | Objective: Metformin is recommended as first-line therapy in individuals with type 2 diabetes mellitus (T2DM), but additional antidiabetes agents are often required to achieve adequate glycemic control.
Methods: This 16-week, open-label pilot study evaluated the glycemic and lipid effects of colesevelam hydrochloride (HCl) 3.75 g/day, rosiglitazone 4 mg/day, or sitagliptin 100 mg/day when added to metformin monotherapy. Adults with inadequately controlled T2DM (glycated hemoglobin [A1C] 7.0%-10.0%, inclusive) on a stable metformin regimen (1500-2550 mg/day, inclusive for </=3 months) were eligible.
Results: In total, 169 subjects were randomized (colesevelam HCl [N=57], rosiglitazone [N=56], and sitagliptin [N=56]) and 141 subjects (83%) completed the study. Least-squares mean reductions in A1C from baseline were observed in all groups (colesevelam HCl: -0.3% [P<0.05]; rosiglitazone: -0.6% [P<0.0001]; sitagliptin: -0.4% [P<0.01]) at Week 16 last observation carried forward (LOCF). At study end, 10 subjects (17.9%) in the colesevelam HCl group, 19 subjects (35.2%) in the rosiglitazone group, and 15 subjects (27.3%) in the sitagliptin group achieved A1C <7.0%. Additionally, colesevelam HCl significantly reduced mean low-density lipoprotein (LDL)-cholesterol levels relative to baseline (11.6%), whereas levels were significantly increased with rosiglitazone and sitagliptin at Week 16 LOCF (7.8% and 7.7%, respectively). Twenty-two subjects (42.3%) in the colesevelam HCl group, 12 subjects (23.5%) in the rosiglitazone group, and 13 subjects (24.5%) in the sitagliptin group achieved LDL-cholesterol <100 mg/dL at Week 16 LOCF.
Conclusion: All three antidiabetes agents significantly improved glycemic control, but only colesevelam HCl also significantly reduced LDL-cholesterol levels in subjects with T2DM. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 19789153 |
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