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Combination therapy for Type 2 diabetes: repaglinide plus rosiglitazone
Author(s) -
Raskin P.,
McGill J.,
Saad M. F.,
Cappleman J. M.,
Kaye W.,
Khutoryansky N.,
Hale P. M.
Publication year - 2004
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/j.1464-5491.2004.01143.x
Subject(s) - repaglinide , rosiglitazone , medicine , metformin , type 2 diabetes , combination therapy , pioglitazone , nateglinide , diabetes mellitus , regimen , endocrinology , gastroenterology , pharmacology
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 HbA 1c 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 Prior therapy was withdrawn for 2 weeks, followed by randomization to repaglinide, rosiglitazone, or repaglinide/rosiglitazone.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 HbA 1c values (primary) or fasting plasma glucose values (secondary). Results Baseline HbA 1c values were comparable (9.3% for repaglinide, 9.0% for rosiglitazone, 9.1% for combination). Mean changes in HbA 1c 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 HbA 1c 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.