Rosiglitazone and Metformin in patients with type-2 Diabetes Mellitus who are inadequately controlled on Metformin alone

Abstract

Type 2 Diabetes Mellitus is almost reaching epidemic levels. With tight hyperglycemic control the risk reduction is 24% for any diabetes related end-point and 32% for death related to diabetes, against only 0.9% decrease in HbAlc level. Complementary mode of actions of Rosiglitazone and Metformin can be used to maximize the therapeutic effect and to decrease the side effects. We evaluated the efficacy, safety and tolerability of the combination of Rosiglitazone and Metformin on change in HbAlc levels from baseline over a period 24 weeks in patients with type 2 diabetes mellitus. Twenty eight type 2 diabetes mellitus patients were recruited randomly presenting to West Medical Ward, Mayo hospital Lahore, through OPD, Diabetic Clinic and Emergency, who were on Metformin alone and were poorly controlled from September 2003 to July 2004. They were given Rosiglitazone 4 mg/day or 8 mg/day with metformin for a period of 24 weeks. Only 2 patients were dropped and 26 patients completed the study (46% were males and 54% were females), and none of patient was dropped due to adverse effects. Their fasting blood sugar measured at baseline and at 4, 8, 16 and 24 week. HbAlc was measured at start and at 24 weeks. The fasting blood glucose responders were 84.6%, with mean fall of 46 mg/dl. HbAlc responders were 73% patients. Average weight gain was 1.125 kg over 24 weeks. Out of 26 patients, 89% showed a mild decrease in hemoglobin concentration but none reaching anemic levels. Only 10% patients had a rise in liver enzymes, which was less than 2 times the normal. Addition of rosiglitazone, in patients with type 2 diabetes mellitus, who are inadequately controlled on metformin alone, resulted in better glycemic control but a large scale study is required and other combinations with Rosiglitazone like sulphonylurea and insulin should be compared.