Skip to main content
SpringerLink
Log in

Rosiglitazone versus bedtime insulin in the treatment of patients with conventional oral antidiabetic drug failure: A 1-year randomized clinical trial

  • Published:
Advances in Therapy Aims and scope Submit manuscript

Abstract

This study was conducted to evaluate the efficacy and tolerability of rosiglitazone in the treatment of patients with secondary oral antidiabetic drug (OAD) failure and to directly compare its use with bedtime insulin. A total of 112 Chinese patients with type 2 diabetes and conventional OAD failure were recruited. Patients were randomly assigned to treatment with rosiglitazone or bedtime isophane insulin; they continued to take their original oral antidiabetic drugs. Glycemic index, other clinical profiles, and tolerability were assessed during treatment and 1 y after add-on treatment was provided. Among the 112 patients, mean age (±SD) was 58.2±11.0 y (median, 58 y; range, 37 to 84 y). Both rosiglitazone (n=56) and insulin (n=56) significantly improved fasting glucose (2.4 and 3.7 mmol/L, respectively) and hemoglobin A1c concentrations (1.1% and 1.3%, respectively). Both therapies increased body mass index after 1 y of treatment (0.9 and 0.8 kg/m2, respectively). Only rosiglitazone increased high-density lipoprotein cholesterol concentrations (0.1 mmol/L). Four patients (7.1 %) who were given rosiglitazone developed adverse effects (2, ankle edema, and 2, gastrointestinal disturbance). Six insulin-treated patients (10.7%) described adverse effects (5, early morning hypoglycemia, and 1, anxiety). Investigators concluded that in Chinese patients with type 2 diabetes and secondary conventional OAD failure, 1 y of treatment with rosiglitazone or bed-time insulin added to the regular regimen resulted in similar improvements in glycemic control. Rosiglitazone was also associated with improved high-density lipoprotein cholesterol levels. The addition of rosiglitazone may offer a safe and effective alternative to bedtime insulin treatment.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Groop LC, Widen E, Ferrannini E. Insulin resistance and insulin deficiency in the pathogenesis of type 2 (non-insulin-dependent) diabetes mellitus: errors of metabolism or of methods?Diabetologia. 1993; 36: 1326–1331.

    Article  PubMed  CAS  Google Scholar 

  2. Gerich JE. Oral hypoglycemic agents.N Engl J Med. 1989; 321: 1231–1245.

    Article  PubMed  CAS  Google Scholar 

  3. Zimmerman BR. Sulfonylureas.Endocrinol Metab Clin North Am. 1997; 26: 511–522.

    Article  PubMed  CAS  Google Scholar 

  4. Pugh JA, Wagner ML, Sawyer J, Ramirez G, Tuley M, Friedberg SJ. Is combination sulfonylurea and insulin therapy useful in NIDDM patients: a meta-analysis.Diabetes Care. 1992; 15: 953–959.

    Article  PubMed  CAS  Google Scholar 

  5. Chow CC, Tsang LWW, Sorensen JP, Cockram CS. Comparison of insulin with or without continuation of oral hypoglycemic agents in the treatment of secondary failure in NIDDM patients.Diabetes Care. 1995; 18: 307–314.

    Article  PubMed  CAS  Google Scholar 

  6. Johnson JL, Wolf SL, Kabadi UM. Efficacy of insulin and sulfonylurea combination therapy in type II diabetes: a meta-analysis of the randomized placebo-controlled trials.Arch Intern Med. 1996; 156: 259–264.

    Article  PubMed  CAS  Google Scholar 

  7. Buse J. Combining insulin and oral agents.Am J Med. 2000; 108(suppl 6A): 23S-32S.

    Article  PubMed  CAS  Google Scholar 

  8. Bloomgarden ZT. Thiazolidinediones.Diabetes Care. 2005; 28: 488–493.

    Article  PubMed  CAS  Google Scholar 

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

    Article  PubMed  CAS  Google Scholar 

  10. Young PW, Cawthorne MA, Coyle PJ, et al. Repeat treatment of obese mice with BRL 49653, a new potent insulin sensitizer, enhances insulin action in white adipocytes: association with increased insulin binding and cell-surface GLUT4 as measured by photoaffinity labeling.Diabetes. 1995; 44: 1087–1092.

    Article  PubMed  CAS  Google Scholar 

  11. Reginato MJ, Lazar MA. Mechanisms by which thiazolidinediones enhance insulin action.Trends Endocrinol Metab. 1999; 10: 9–13.

    Article  PubMed  CAS  Google Scholar 

  12. Raskin P, Rappaport EB, Cole ST, Yan Y, Patwardhan R, Freed MI. Rosiglitazone short-term monotherapy lowers fasting and post-prandial glucose in patients with Type II diabetes.Diabetologia. 2000; 43: 278–284.

    Article  PubMed  CAS  Google Scholar 

  13. Wolffenbuttel BH, Gomis R, Squatrito S, Jones NP, Patwardhan RN. Addition of low-dose rosiglitazone to sulphonylurea therapy improves glycaemic control in Type 2 diabetic patients.Diabetes Med. 2000; 17: 40–47.

    Article  CAS  Google Scholar 

  14. 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.

    Article  PubMed  CAS  Google Scholar 

  15. Friedewald WT, Levy RI, Fredrickason DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge.Clin Chem. 1972; 18: 499–502.

    PubMed  CAS  Google Scholar 

  16. Korytkowski M. When oral agents fail: practical barriers to starting insulin.Int J Obes Relat Metab Disord. 2002; 26(suppl 3): S18-S24.

    Article  PubMed  CAS  Google Scholar 

  17. Stolar MW. Atherosclerosis in diabetes: the role of hyperinsulinemia.Metabolism. 1988; 37(suppl 1): 1–9.

    Article  PubMed  CAS  Google Scholar 

  18. Orbay E, Sargin M, Sargin H, Gozu H, Bayramicli OU, Yayla A. Addition of rosiglitazone to glimepirid and metformin combination therapy in type 2 diabetes.Endocr J. 2004; 51: 521–527.

    Article  PubMed  CAS  Google Scholar 

  19. Dailey GE, Noor MA, Park JS, Bruce S, Fiedorek FT. Glycemic control with glyburide/metformin tablets in combination with rosiglitazone in patients with type 2 diabetes: a randomized, double-blind trial.Am J Med. 2004; 116: 223–229.

    Article  PubMed  CAS  Google Scholar 

  20. Aljabri K, Kozak SE, Thompson DM. Addition of pioglitazone or bedtime insulin to maximal doses of sulfonylurea and metformin in type 2 diabetes patients with poor glucose control: a prospective, randomized trial.Am J Med. 2004; 116: 230–235.

    Article  PubMed  CAS  Google Scholar 

  21. Florkowski CM. Management of co-existing diabetes mellitus and dyslipidemia: defining the role of thiazolidinediones.Am J Cardiovasc Drugs. 2002; 2: 15–21.

    Article  PubMed  CAS  Google Scholar 

  22. Lee CH, Olson P, Evans RM. Minireview: lipid metabolism, metabolic diseases, and peroxisome proliferator-activated receptors.Endocrinology. 2003; 144: 2201–2207.

    Article  PubMed  CAS  Google Scholar 

  23. Yki-Jarvinen H, Ryysy L, Nikkila K, Tulokas T, Vanamo R, Heikkila M. Comparison of bedtime insulin regimens in patients with type 2 diabetes mellitus: a randomized, controlled trial.Ann Intern Med. 1999; 130: 389–396.

    PubMed  CAS  Google Scholar 

  24. Scheen AJ. Thiazolidinediones and liver toxicity.Diabetes Metab. 2001; 27: 305–313.

    PubMed  CAS  Google Scholar 

  25. Scheen AJ. Hepatotoxicity with thiazolidinediones: is it a class effect?Drug Saf. 2001; 24: 873–888.

    Article  PubMed  CAS  Google Scholar 

  26. Lebovitz HE, Kreider M, Freed MI. Evaluation of liver function in type 2 diabetic patients during clinical trials: evidence that rosiglitazone does not cause hepatic dysfunction.Diabetes Care. 2002; 25: 815–821.

    Article  PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Medicine, AH Nethersole Hospital, 11 Chuen On Road Tai Po, Hong Kong

    Gary T. C. Ko MD, FRCPI & Patrick C. C. Tsang MBBS, MRCP

  2. St. Teresa’s Hospital, AH Nethersole Hospital, Hong Kong, China

    Hendena P. S. Wai MBChB, FRCR

  3. Department of Medicine, AH Nethersole Hospital, Hong Kong, China

    Eva C. Y. Kan MPhil & Hamish C. K. Chan MBChB, FRCP

Authors
  1. Gary T. C. Ko MD, FRCPI
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Patrick C. C. Tsang MBBS, MRCP
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Hendena P. S. Wai MBChB, FRCR
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Eva C. Y. Kan MPhil
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Hamish C. K. Chan MBChB, FRCP
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

About this article

Cite this article

Ko, G.T.C., Tsang, P.C.C., Wai, H.P.S. et al. Rosiglitazone versus bedtime insulin in the treatment of patients with conventional oral antidiabetic drug failure: A 1-year randomized clinical trial. Adv Therapy 23, 799–808 (2006). https://doi.org/10.1007/BF02850321

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1007/BF02850321

Keywords

Search

Navigation