EFFECTS OF COLESEVELAM, ROSIGLITAZONE, OR SITAGLIPTIN ON GLYCEMIC CONTROL AND LIPID PROFILE IN PATIENTS WITH TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED BY METFORMIN MONOTHERAPY

Objective: To evaluate the glycemic effect of colesevelam, rosiglitazone, or sitagliptin when added to metformi monotherapy in patients with type 2 diabetes mellitus (DM) and to examine the effects of these antidiabetes agents on lipid and lipoprotein levels Methods: This 16-week, open-label pilot study conducted between May 2007 and April 2008 at 20 sites in the United States, 7 sites in Mexico, and 6 sites in Colombia, enrolled adults with inadequately controlled type 2 DM (glycated hemoglbobin [HbA(Ic)], 7 0%-10 0%) on a stable metformin regimen (1500-2550 mg daily for >= 3 months) At Week 0, participants were randomly assigned 1 1 1 to open-label colesevelam hydrochloride, 3 75 g daily, open-label rosiglitazone maleate, 4 mg daily, or open-label sitagliptin phosphate, 100 mg daily, in addition to existing metformin therapy The primary efficacy variable was the change in HbA(Ic) from baseline to Week 16 with last (postbaseline) observation carried forward Results: In total, 169 participants were randomly assgined to treatment groups (colesevelam, n = 57, rosiglitazone, n = 56, and sitagliptin, n = 56), and 141 participants (83 4%) completed the study Least-squares mean reduction in HbA(Ic) from baseline were observed in all groups at Week 16 last observation carried forward (colesevelam, -0.3% [P<031] rosiglitazone -0 66% [P<.001]. sitagliptin - 04$ [P<009]) At study end, 10 of 56 participants (17 9%) in the colesevelam group, 19 of 54 (35 2%) in the rosiglitazone group, and 15 of 55 (27 3%) in the sitagliptin group achieved HbA(Ic) <70% Colesevelam significantly reduced mean low-density lipoprotein (LDL)-cholesterol levels relative to baseline (11.6%), whereas levels were signifiantly increased with rosiglitazone and sitagliptin at week 16 last observation carried forward (7 8% and 7 7%, respectively) Twenty-two of 52 participants (42 3%) in the colesevelam group, 12 of 51 (23.5%) in the rosiglitazone group, and 13 of 53 (24 5%) in the sitagliptin group achieved LDL cholesterol <100 mg/dL at Week 16 last observation carried forward Conslusion: All 3 antidiabetes agents significantly improved glycemic control, but only colesevelam also significantly reduced LDL-cholesterol levels in patients with type 2 DM (Endocr Pract, 2010;16;21-29)