Korean Diabetes J.  2008 Dec;32(6):506-512. 10.4093/kdj.2008.32.6.506.

The Efficacy of Fixed Dose Rosiglitazone and Metformin Combination Therapy in Poorly Controlled Subjects with Type 2 Diabetes Mellitus

• Sohn TS
• Lee JI
• Kim IJ
• Min KW
• Son HS

• KMID: 2222458
• DOI: http://doi.org/10.4093/kdj.2008.32.6.506

Abstract

BACKGROUND: Obese type 2 diabetic subjects are recently increasing in Korea, indicating the importance of insulin resistance rather than insulin secretory defects in the pathophysioloy of type 2 diabetes. The purpose of this study is to evaluate the safety and efficacy of fixed dose rosiglitazone/metformin combination therapy in poorly controlled subjects with type 2 diabetes mellitus.
METHODS
12 type 2 diabetic subjects who had a HbA1c > 11% or fasting plasma glucose > 15 mmol/L were included. After a 2 week screening period, the subjected took the fixed does rosiglitazone/metformin for 24 weeks. The treatment with rosiglitazone/metformin began at week 0 with an initial dose of 4 mg/1000 mg and, unless tolerability issues arose, subjects would be increased to 6 mg/1500 mg at week 4 and at week 8 to the maximum dose of 8 mg/2000 mg. The primary object of this study was to characterize the magnitude of HbA1c reduction from baseline after 24 weeks of rosiglitazone and metformin treatment in poorly controlled type 2 diabetics.
RESULTS
The mean age of the subjects was 48.9 +/- 10.6 years old, body mass index was 25.0 +/- 3.5 kg/m2, HbA1c was 12.0 +/- 1.0%, and fasting plasma glucose was 16.3 +/- 3.1 mmol/L. HbA1c was reduced to 7.54 +/- 1.45% and fasting plasma glucose reduced to 7.96 +/- 2.38 mmol/L at week 24. The proportion of HbA1c responder who showed the reduction from baseline of > or = 0.7% or HbA1c < 7% was 11 among 12 subjects (91.7%). 41% of the subjects (5 among 12 subjects) achieved HbA1c level < 7.0% and 75% (9 among 12 subjects) achieved HbA1c level < 8.0%.
CONCLUSIONS
In this study, rosiglitazone and metformin combination therapy was effective in glycemic control in poorly controlled subjects with type 2 diabetes mellitus.

Keyword

Metformin; Rosiglitazone; Type 2 diabetes

MeSH Terms

Body Mass Index
Diabetes Mellitus, Type 2
Fasting
Glucose
Insulin
Insulin Resistance
Korea
Mass Screening
Metformin
Plasma
Thiazolidinediones
Glucose
Insulin
Metformin
Thiazolidinediones

Reference

1. Cho NH. Prevalence Of Diabetes And Management Status In Korean Population. Korean J Med. 2005. 68:1–3.

2. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998. 352:837–853.

3. Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA. 1999. 281:2005–2012.

4. Fonseca V, Rosenstock J, Patwardhan R, Salzman A. Effect of metformin and rosiglitazone combination therapy in patients with type 2 diabetes mellitus: a randomized controlled trial. JAMA. 2000. 283:1695–1702.

5. Jones TA, Sautter M, Van Gaal LF, Jones NP. Addition of rosiglitazone to metformin is most effective in obese, insulin-resistant patients with type 2 diabetes. Diabetes Obes Metab. 2003. 5:163–170.

6. Park JY, Lee KU, Kim CH, Kim HK, Hong SK, Park KS, Lee HK, Min HK. Past and current obesity in Koreans with non-insulin-dependent diabetes mellitus. Diabetes Res Clin Pract. 1997. 35:49–56.

7. Yoon KH, Ko SH, Cho JH, Lee JM, Ahn YB, Song KH, Yoo SJ, Kang MI, Cha BY, Lee KW, Son HY, Kang SK, Kim HS, Lee IK, Bonner-Weir S. Selective beta-cell loss and alpha-cell expansion in patients with type 2 diabetes mellitus in Korea. J Clin Endocrinol Metab. 2003. 88:2300–2308.

8. Kim DJ, Song KE, Park JW, Cho HK, Lee KW, Huh KB. Clinical characteristics of Korean type 2 diabetic patients in 2005. Diabetes Res Clin Pract. 2007. 77S:S252–S257.

9. Ginsberg HN. Insulin resistance and cardiovascular disease. J Clin Invest. 2000. 106:453–458.

10. Grundy SM, Benjamin IJ, Burke GL, Chait A, Eckel RH, Howard BV, Mitch W, Smith SC Jr, Sowers JR. Diabetes and cardiovascular disease. Circulation. 1999. 100:1134–1146.

11. Baily CJ. Treating insulin resistance in type 2 diabetes with metformin and thiazolidinediones. Diabetes Obes Metab. 2005. 7:675–691.

12. Nathan DM, Buse JB, Davidson MB, Heine RJ, Holman RR, Sherwin R, Zinman B. Management of hyperglycemia in type 2 diabetes: A consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2006. 29:1963–1972.

13. Diamant M, Heine R. Thiazolidinediones in type 2 diabetes mellitus: current clinical evidence. Drugs. 2003. 63:1373–1405.

14. Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP, Kravitz BG, Lachin JM, O'Neill MC, Zinman B, Viberti G. ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006. 355:2427–2443.

15. Miyazaki Y, Glass L, Triplitt C, Matsuda M, Cusi K, Mahankali A, Mahankali S, Mandarino LJ, DeFronzo RA. Effect of rosiglitazone on glucose and non-esterified fatty acid metabolism in Type II diabetic patients. Diabetologia. 2001. 44:2210–2219.

16. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007. 356:2457–2471.

17. Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJ. Rosiglitazone evaluated for cardiovascular outcomes--an interim analysis. N Engl J Med. 2007. 357:28–38.