PMID- 14757293 OWN - NLM STAT- MEDLINE DCOM- 20041007 LR - 20221207 IS - 0168-8227 (Print) IS - 0168-8227 (Linking) VI - 63 IP - 3 DP - 2004 Mar TI - Combination therapy with rosiglitazone and glibenclamide compared with upward titration of glibenclamide alone in patients with type 2 diabetes mellitus. PG - 213-23 AB - AIM: To compare the efficacy of combination therapy using rosiglitazone (8 mg per day) and glibenclamide (7.5 mg per day) with upward titration of glibenclamide as monotherapy (maximum dose=15 mg per day) in reducing HbA(1c) levels over 26 weeks in patients with type 2 diabetes mellitus (T2DM). METHODS: Three hundred and forty patients with T2DM inadequately controlled (FPG > or =7.0 and < or =15.0 mmol/l) on glibenclamide 7.5 mg per day were randomised to either additional treatment with rosiglitazone 8 mg per day or up-titration of the glibenclamide dose (maximum dose=15 mg per day). RESULTS: After 26 weeks, treatment with rosiglitazone combination reduced HbA(1c) by 0.81% (P<0.0001) and FPG by 2.4 mmol/l (P<0.0001) compared with glibenclamide monotherapy. HOMA-S and HOMA-B increased by 12 and 28%, respectively (P<0.0001 for both) with combination compared with glibenclamide monotherapy. With rosiglitazone combination and glibenclamide monotherapy, total cholesterol: HDL ratio reduced by 5 and 13%, triglycerides reduced by 6 and 2%, and FFAs reduced by 15 and 8%, respectively. Both treatments were well tolerated and had predictable safety profiles. CONCLUSION: For patients inadequately controlled on glibenclamide, addition of rosiglitazone provides significantly improved glycaemic control compared with uptitration of glibenclamide. This may be preferable to continued monotherapy with higher doses of glibenclamide. FAU - Kerenyi, Zsuzsa AU - Kerenyi Z AD - Fourth Department of Medicine, Szent Imre Hospital, Budapest, Hungary. FAU - Samer, Holger AU - Samer H FAU - James, Rachel AU - James R FAU - Yan, Ying AU - Yan Y FAU - Stewart, Murray AU - Stewart M LA - eng PT - Clinical Trial PT - Journal Article PT - Randomized Controlled Trial PL - Ireland TA - Diabetes Res Clin Pract JT - Diabetes research and clinical practice JID - 8508335 RN - 0 (C-Peptide) RN - 0 (Cholesterol, HDL) RN - 0 (Cholesterol, LDL) RN - 0 (Fatty Acids, Nonesterified) RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Insulin) RN - 0 (Placebos) RN - 0 (Thiazolidinediones) RN - 0 (Triglycerides) RN - 05V02F2KDG (Rosiglitazone) RN - SX6K58TVWC (Glyburide) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - C-Peptide/blood MH - Cholesterol, HDL/blood MH - Cholesterol, LDL/blood MH - Diabetes Mellitus, Type 2/*drug therapy MH - Double-Blind Method MH - Drug Therapy, Combination MH - Fasting MH - Fatty Acids, Nonesterified/blood MH - Female MH - Glyburide/adverse effects/*therapeutic use MH - Glycated Hemoglobin/analysis MH - Humans MH - Hypoglycemic Agents/*therapeutic use MH - Insulin/blood MH - Male MH - Middle Aged MH - Placebos MH - Rosiglitazone MH - Thiazolidinediones/adverse effects/*therapeutic use MH - Triglycerides/blood EDAT- 2004/02/06 05:00 MHDA- 2004/10/08 09:00 CRDT- 2004/02/06 05:00 PHST- 2004/02/06 05:00 [pubmed] PHST- 2004/10/08 09:00 [medline] PHST- 2004/02/06 05:00 [entrez] AID - S0168822703002262 [pii] AID - 10.1016/j.diabres.2003.09.009 [doi] PST - ppublish SO - Diabetes Res Clin Pract. 2004 Mar;63(3):213-23. doi: 10.1016/j.diabres.2003.09.009.