Combination therapy for Type 2 diabetes: repaglinide plus rosiglitazone

  1. P. Raskin1,*,
  2. J. McGill1,2,
  3. M. F. Saad1,3,
  4. J. M. Cappleman1,4,
  5. W. Kaye1,5,
  6. N. Khutoryansky1,6,
  7. P. M. Hale1,6

Article first published online: 5 FEB 2004

DOI: 10.1111/j.1464-5491.2004.01143.x

Issue

Diabetic Medicine

Diabetic Medicine

Volume 21, Issue 4, pages 329–335, April 2004

Additional Information

How to Cite

Raskin, P., McGill, J., Saad, M. F., Cappleman, J. M., Kaye, W., Khutoryansky, N. and Hale, P. M. (2004), Combination therapy for Type 2 diabetes: repaglinide plus rosiglitazone. Diabetic Medicine, 21: 329–335. doi: 10.1111/j.1464-5491.2004.01143.x

Author Information

  1. 1

    University of Texas, South western Medical Center, Dallas, TX,

  2. 2

    Washington University, St Louis, MO,

  3. 3

    Los Angeles Diabetes Center, Alhambra, CA,

  4. 4

    Primary Care Specialists, Ocoee, FL,

  5. 5

    Metabolic Research Institute Inc., West Palm Beach, FL, and

  6. 6

    Novo Nordisk Pharmaceuticals Inc., Princeton, NJ, USA

* Dr Philip Raskin, The University of Texas, South western Medical Center at Dallas, Department of Internal Medicine, 5323 Harry Hines Blvd., Dallas, TX 75235-8858, USA. E-mail: philip.raskin@utsouth-western.edu

Publication History

  1. Issue published online: 20 FEB 2004
  2. Article first published online: 5 FEB 2004
  3. Accepted 17 June 2003

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Keywords:

  • thiazolidinedione;
  • oral antidiabetic drug;
  • insulin secretagogue;
  • lipids

Abstract

Aims  This 24-week, randomized, multicentre, open-label, parallel-group clinical trial compared efficacy and safety of repaglinide monotherapy, rosiglitazone monotherapy, and combination therapy (repaglinide plus rosiglitazone) in Type 2 diabetes after unsatisfactory response to sulphonylurea or metformin monotherapy.

Methods  Enrolled patients (n = 252) were adults having Type 2 diabetes for at least 1 year, with HbA1c values > 7.0% after previous monotherapy (sulphonylurea or metformin, ≥ 50% maximal dose). Prior therapy was withdrawn for 2 weeks, followed by randomization to repaglinide, rosiglitazone, or repaglinide/rosiglitazone. Study treatments were initiated with a 12-week dose optimization period (doses optimized according to labelling), followed by a 12-week maintenance period. Efficacy endpoints were changes in HbA1c values (primary) or fasting plasma glucose values (secondary).

Results  Baseline HbA1c values were comparable (9.3% for repaglinide, 9.0% for rosiglitazone, 9.1% for combination). Mean changes in HbA1c values at the end of treatment were greater for repaglinide/rosiglitazone therapy (−1.43%) than for repaglinide (−0.17%) or rosiglitazone (−0.56%) monotherapy. Reductions of fasting plasma glucose values were also greater for combination therapy (−5.2 mmol/l, −94 mg/dl) than for repaglinide monotherapy (−3.0 mmol/l, −54 mg/dl) or rosiglitazone monotherapy (−3.7 mmol/l, −67 mg/dl). Minor hypoglycaemic events occurred in 9% of combination therapy patients, vs. 6% for repaglinide and 2% for rosiglitazone. Individual weight gains for combination therapy were correlated to HbA1c response.

Conclusions  The combination therapy regimen was well tolerated. In patients previously showing unsatisfactory response to oral monotherapy, glycaemic reductions were greater for the repaglinide/rosiglitazone combination regimen than for use of either repaglinide or rosiglitazone alone.

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