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Troglitazone in combination with sulphonylurea improves glycaemic control in Type 2 diabetic patients inadequately controlled by sulphonylurea therapy alone
Author(s) -
Buysschaert M.,
Bobbioni E.,
Starkie M.,
Frith L.,
Group For The Troglitazone Study
Publication year - 1999
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 - 10.1046/j.1464-5491.1999.00029.x
Subject(s) - troglitazone , medicine , endocrinology , tolerability , type 2 diabetes , placebo , adverse effect , diabetes mellitus , combination therapy , peroxisome proliferator activated receptor , receptor , alternative medicine , pathology
Summary Aim The aim of this study was to investigate the effectiveness of troglitazone (a peroxisome proliferator‐activated receptor‐γ agonist developed primarily for the treatment of Type 2 diabetes mellitus (DM)), 100 or 200 mg/day, in terms of glycaemic control, lipid profile and tolerability, when given in addition to existing sulphonylurea therapy. Methods A 16‐week, randomized, parallel‐group placebo‐controlled trial in 259 Type 2 diabetic patients already on sulphonylurea therapy. Results At week 16, adjusted geometric mean HbA1c with troglitazone 100 mg (7.7%; P = 0.023) and 200 mg (7.4%; P < 0.001) was lower with sulphonylurea alone (8.2%). At all weeks, adjusted geometric mean fasting serum glucose levels were lower in both troglitazone groups, compared with sulphonylurea alone ( P = 0.007 to P < 0.001). At week 16, both troglitazone groups showed reductions in immune reactive insulin compared with sulphonylurea alone (200 mg, 13%; P = 0.032: 100 mg, 5%; NS). Troglitazone reduced serum levels of nonesterified fatty acids at week 16 (100 mg, 12%; P = 0.042) and at all weeks (200 mg, 17–24%; P = 0.014 to P < 0.001). The incidence of drug‐related adverse events was similar in all groups (23–24% of patients). There was no apparent association between hypoglycaemia and the addition of troglitazone to sulphonylurea therapy. Conclusions Troglitazone 100 or 200 mg added to usual sulphonylurea therapy in patients with Type 2 DM is associated with a significant improvement in glycaemic control, without altering the adverse‐event profile of the sulphonylurea. Diabet. Med. 16, 147–153 (1999)