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Results of a randomized, double-blind, placebo-controlled study administering glimepiride to patients with type 2 diabetes mellitus inadequately controlled with rosiglitazone monotherapy.
Clin Ther. 2004 Nov; 26(11):1783-90.CT

Abstract

OBJECTIVE

This study was designed to assess the efficacy and safety of glimepiride plus rosiglitazone for type 2 diabetes mellitus (DM) inadequately controlled with rosiglitazone monotherapy.

METHODS

This was a randomized, double-blind, placebo-controlled, multicenter study Patients were assigned to a 6-week forced titration of either glimepiride or placebo in combination with rosiglitazone (4 or 8 mg/d) followed by a maintenance period of 20 weeks. The outcomes were changes in glycosylated hemoglobin (HbA(1c)), fasting plasma glucose (FPG), lipid levels, and body weight, as well as safety measures.

RESULTS

Forty patients (23 women, 17 men) with type 2 DM were included in the study The mean (SD) age was 60.2 (7.8) years in the glimepiride group and 50.8 (9.7) years in the placebo group (P < 0.002). Mean (SD) screening HbA(1c) was 7.9% (0.6%) among patients receiving glimepiride and 8.4% (0.6%) among those receiving placebo. Mean (SD) duration of DM was 7.2 (8.8) and 4.6 (4.0) years, respectively Mean (SD) FPG at randomization was 155.0 (22.9) mg/dL and 180.2 (36.9) mg/dL, respectively (P < 0.018). Combination therapy with glimepiride produced greater reductions versus placebo combination in HbA(1c) (mean [SE], -12% [0.1%] vs -03% [02%]; P < 0.001) and FPG (mean [SE], -24.4 [6.0] mg/dL vs 5.9 [8.0] mg/dL; P < 0.006). More patients in the glimepiride group achieved the HbA(1c) target of < or =7% (60% vs 143%; P < 0.008). There were no significant differences in the rate or type of adverse events between groups, and no episodes of severe hypoglycemia occurred with either treatment

CONCLUSIONS

The results of this study suggest that the combination of glimepiride and rosiglitazone was efficacious and well tolerated in a small sample of patients with type 2 DM. The combination might be used to improve glycemic control in patients inadequately controlled with rosiglitazone monotherapy.

Authors+Show Affiliations

Dennis McCluskey and Associates, Mogadore, Ohio, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

15639690

Citation

McCluskey, Dennis, et al. "Results of a Randomized, Double-blind, Placebo-controlled Study Administering Glimepiride to Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Rosiglitazone Monotherapy." Clinical Therapeutics, vol. 26, no. 11, 2004, pp. 1783-90.
McCluskey D, Touger MS, Melis R, et al. Results of a randomized, double-blind, placebo-controlled study administering glimepiride to patients with type 2 diabetes mellitus inadequately controlled with rosiglitazone monotherapy. Clin Ther. 2004;26(11):1783-90.
McCluskey, D., Touger, M. S., Melis, R., Schleusener, D. S., & McCluskey, D. (2004). Results of a randomized, double-blind, placebo-controlled study administering glimepiride to patients with type 2 diabetes mellitus inadequately controlled with rosiglitazone monotherapy. Clinical Therapeutics, 26(11), 1783-90.
McCluskey D, et al. Results of a Randomized, Double-blind, Placebo-controlled Study Administering Glimepiride to Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Rosiglitazone Monotherapy. Clin Ther. 2004;26(11):1783-90. PubMed PMID: 15639690.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Results of a randomized, double-blind, placebo-controlled study administering glimepiride to patients with type 2 diabetes mellitus inadequately controlled with rosiglitazone monotherapy. AU - McCluskey,Dennis, AU - Touger,M Scott, AU - Melis,Robert, AU - Schleusener,Debra S, AU - McCluskey,Dennis, PY - 2004/09/23/accepted PY - 2005/1/11/pubmed PY - 2005/3/30/medline PY - 2005/1/11/entrez SP - 1783 EP - 90 JF - Clinical therapeutics JO - Clin Ther VL - 26 IS - 11 N2 - OBJECTIVE: This study was designed to assess the efficacy and safety of glimepiride plus rosiglitazone for type 2 diabetes mellitus (DM) inadequately controlled with rosiglitazone monotherapy. METHODS: This was a randomized, double-blind, placebo-controlled, multicenter study Patients were assigned to a 6-week forced titration of either glimepiride or placebo in combination with rosiglitazone (4 or 8 mg/d) followed by a maintenance period of 20 weeks. The outcomes were changes in glycosylated hemoglobin (HbA(1c)), fasting plasma glucose (FPG), lipid levels, and body weight, as well as safety measures. RESULTS: Forty patients (23 women, 17 men) with type 2 DM were included in the study The mean (SD) age was 60.2 (7.8) years in the glimepiride group and 50.8 (9.7) years in the placebo group (P < 0.002). Mean (SD) screening HbA(1c) was 7.9% (0.6%) among patients receiving glimepiride and 8.4% (0.6%) among those receiving placebo. Mean (SD) duration of DM was 7.2 (8.8) and 4.6 (4.0) years, respectively Mean (SD) FPG at randomization was 155.0 (22.9) mg/dL and 180.2 (36.9) mg/dL, respectively (P < 0.018). Combination therapy with glimepiride produced greater reductions versus placebo combination in HbA(1c) (mean [SE], -12% [0.1%] vs -03% [02%]; P < 0.001) and FPG (mean [SE], -24.4 [6.0] mg/dL vs 5.9 [8.0] mg/dL; P < 0.006). More patients in the glimepiride group achieved the HbA(1c) target of < or =7% (60% vs 143%; P < 0.008). There were no significant differences in the rate or type of adverse events between groups, and no episodes of severe hypoglycemia occurred with either treatment CONCLUSIONS: The results of this study suggest that the combination of glimepiride and rosiglitazone was efficacious and well tolerated in a small sample of patients with type 2 DM. The combination might be used to improve glycemic control in patients inadequately controlled with rosiglitazone monotherapy. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/15639690/Results_of_a_randomized_double_blind_placebo_controlled_study_administering_glimepiride_to_patients_with_type_2_diabetes_mellitus_inadequately_controlled_with_rosiglitazone_monotherapy_ L2 - https://linkinghub.elsevier.com/retrieve/pii/0149-2918(04)80342-4 DB - PRIME DP - Unbound Medicine ER -