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Metformin-glibenclamide versus metformin plus rosiglitazone in patients with type 2 diabetes inadequately controlled on metformin monotherapy.
Diabetes Obes Metab 2006; 8(2):156-63DO

Abstract

AIM

This double-blind study evaluated the efficacy and safety of metformin-glibenclamide tablets vs. metformin plus rosiglitazone therapy in patients with type 2 diabetes inadequately controlled on metformin monotherapy.

SUBJECTS AND METHODS

After an open-label, metformin lead-in phase, 318 patients were randomly assigned to treatment based on metformin-glibenclamide 500/2.5 mg tablets (initial daily dose 1000/5 mg) or metformin 500 mg plus rosiglitazone 4 mg (initial daily dose 1000-2000 mg + 4 mg, depending on previous treatment) for 24 weeks. Doses were titrated to achieve the therapeutic glycaemic target. The primary efficacy variable was the change in HbA1C.

RESULTS

At week 24, metformin-glibenclamide tablets resulted in significantly greater reductions in HbA1C (-1.5%) and fasting plasma glucose [-2.6 mmol/l (-46 mg/dl)] than metformin plus rosiglitazone [-1.1%, p < 0.001; -2 mmol/l (-36 mg/dl), p = 0.03]. More patients receiving metformin-glibenclamide attained HbA1C <7.0% than did those in the metformin plus rosiglitazone group (60 vs. 47%) and had fasting plasma glucose levels <7 mmol/l (<126 mg/dl) by week 24 (34 vs. 25%). Both treatments were well tolerated. Frequency of adverse gastrointestinal events was comparable between groups. Four per cent of patients receiving metformin-glibenclamide withdrew because of symptomatic hypoglycaemia contrasted with 3% of patients receiving metformin plus rosiglitazone who withdrew because of persistent hyperglycaemia. Hypoglycaemic events were mild or moderate in intensity and were easily self-managed.

CONCLUSIONS

Metformin-glibenclamide tablets resulted in significantly greater reductions in HbA1C and fasting plasma glucose compared with metformin plus rosiglitazone in patients with type 2 diabetes inadequately controlled on metformin monotherapy.

Authors+Show Affiliations

Department of Medicine, Baylor College of Medicine, Houston, TX, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

16448519

Citation

Garber, A, et al. "Metformin-glibenclamide Versus Metformin Plus Rosiglitazone in Patients With Type 2 Diabetes Inadequately Controlled On Metformin Monotherapy." Diabetes, Obesity & Metabolism, vol. 8, no. 2, 2006, pp. 156-63.
Garber A, Klein E, Bruce S, et al. Metformin-glibenclamide versus metformin plus rosiglitazone in patients with type 2 diabetes inadequately controlled on metformin monotherapy. Diabetes Obes Metab. 2006;8(2):156-63.
Garber, A., Klein, E., Bruce, S., Sankoh, S., & Mohideen, P. (2006). Metformin-glibenclamide versus metformin plus rosiglitazone in patients with type 2 diabetes inadequately controlled on metformin monotherapy. Diabetes, Obesity & Metabolism, 8(2), pp. 156-63.
Garber A, et al. Metformin-glibenclamide Versus Metformin Plus Rosiglitazone in Patients With Type 2 Diabetes Inadequately Controlled On Metformin Monotherapy. Diabetes Obes Metab. 2006;8(2):156-63. PubMed PMID: 16448519.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Metformin-glibenclamide versus metformin plus rosiglitazone in patients with type 2 diabetes inadequately controlled on metformin monotherapy. AU - Garber,A, AU - Klein,E, AU - Bruce,S, AU - Sankoh,S, AU - Mohideen,P, PY - 2006/2/2/pubmed PY - 2006/8/22/medline PY - 2006/2/2/entrez SP - 156 EP - 63 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 8 IS - 2 N2 - AIM: This double-blind study evaluated the efficacy and safety of metformin-glibenclamide tablets vs. metformin plus rosiglitazone therapy in patients with type 2 diabetes inadequately controlled on metformin monotherapy. SUBJECTS AND METHODS: After an open-label, metformin lead-in phase, 318 patients were randomly assigned to treatment based on metformin-glibenclamide 500/2.5 mg tablets (initial daily dose 1000/5 mg) or metformin 500 mg plus rosiglitazone 4 mg (initial daily dose 1000-2000 mg + 4 mg, depending on previous treatment) for 24 weeks. Doses were titrated to achieve the therapeutic glycaemic target. The primary efficacy variable was the change in HbA1C. RESULTS: At week 24, metformin-glibenclamide tablets resulted in significantly greater reductions in HbA1C (-1.5%) and fasting plasma glucose [-2.6 mmol/l (-46 mg/dl)] than metformin plus rosiglitazone [-1.1%, p < 0.001; -2 mmol/l (-36 mg/dl), p = 0.03]. More patients receiving metformin-glibenclamide attained HbA1C <7.0% than did those in the metformin plus rosiglitazone group (60 vs. 47%) and had fasting plasma glucose levels <7 mmol/l (<126 mg/dl) by week 24 (34 vs. 25%). Both treatments were well tolerated. Frequency of adverse gastrointestinal events was comparable between groups. Four per cent of patients receiving metformin-glibenclamide withdrew because of symptomatic hypoglycaemia contrasted with 3% of patients receiving metformin plus rosiglitazone who withdrew because of persistent hyperglycaemia. Hypoglycaemic events were mild or moderate in intensity and were easily self-managed. CONCLUSIONS: Metformin-glibenclamide tablets resulted in significantly greater reductions in HbA1C and fasting plasma glucose compared with metformin plus rosiglitazone in patients with type 2 diabetes inadequately controlled on metformin monotherapy. SN - 1462-8902 UR - https://www.unboundmedicine.com/medline/citation/16448519/Metformin_glibenclamide_versus_metformin_plus_rosiglitazone_in_patients_with_type_2_diabetes_inadequately_controlled_on_metformin_monotherapy_ L2 - https://doi.org/10.1111/j.1463-1326.2005.00570.x DB - PRIME DP - Unbound Medicine ER -