Glyburide and Metformin (Glyburide / Metformin Hydrochloride) - Summary

SUMMARY

Glyburide and metformin hydrochloride tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes, glyburide and metformin hydrochloride. Glyburide is an oral antihyperglycemic drug of the sulfonylurea class.

Glyburide and metformin hydrochloride tablets are indicated as initial therapy, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone.

Glyburide and metformin hydrochloride tablets are indicated as second-line therapy when diet, exercise, and initial treatment with a sulfonylurea or metformin do not result in adequate glycemic control in patients with type 2 diabetes. For patients requiring additional therapy, a thiazolidinedione may be added to glyburide and metformin hydrochloride tablets to achieve additional glycemic control.

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NEWS HIGHLIGHTS

Published Studies Related to Glyburide and Metformin (Glyburide / Metformin)

Saxagliptin, a potent, selective inhibitor of DPP-4, does not alter the pharmacokinetics of three oral antidiabetic drugs (metformin, glyburide or pioglitazone) in healthy subjects. [2011.07]
AIM: To evaluate the pharmacokinetic interactions of the potent, selective, dipeptidyl peptidase-4 inhibitor, saxagliptin, in combination with metformin, glyburide or pioglitazone... CONCLUSIONS: Saxagliptin can be co-administered with metformin, glyburide or pioglitazone without a need for dose adjustment of either saxagliptin or these OADs. (c) 2011 Blackwell Publishing Ltd.

Renal function in type 2 diabetes with rosiglitazone, metformin, and glyburide monotherapy. [2011.05]
BACKGROUND AND OBJECTIVES: In ADOPT (A Diabetes Outcomes Prevention Trial), initial monotherapy with rosiglitazone provided more durable glycemic control than metformin or glyburide in patients with recently diagnosed type 2 diabetes. Herein, we examine differences in albumin excretion, renal function (estimated GFR), and BP over 5 years between treatment groups... CONCLUSIONS: Over a 5-year period, initial monotherapy with rosiglitazone retards the rise of ACR compared with metformin, preserves eGFR compared with glyburide, and lowers BP relative to both comparators. Copyright (c) 2011 by the American Society of Nephrology

Effects of rosiglitazone, glyburide, and metformin on beta-cell function and insulin sensitivity in ADOPT. [2011.05]
CONCLUSIONS: The favorable combined changes in beta-cell function and insulin sensitivity over time with rosiglitazone appear to be responsible for its superior glycemic durability over metformin and glyburide as initial monotherapy in type 2 diabetes.

Comparison of pioglitazone vs glyburide in early heart failure: insights from a randomized controlled study of patients with type 2 diabetes and mild cardiac disease. [2010.05]
Pioglitazone may cause fluid retention, a well-known side effect of thiazolidinediones, and may exacerbate heart failure. Patients with type 2 diabetes and mild cardiac disease (New York Heart Association functional class I) received pioglitazone (n=151) or glyburide (n=149) for 1 year.Echocardiographic data suggested no significant deterioration in cardiac function with pioglitazone, although more heart failure (10 vs 7 patients), edema (21.2% vs 12.8%), and weight gain (2.56+/-4.62 kg vs 0.86+/-3.85 kg) were observed than with glyburide.

Metformin compared with glyburide in gestational diabetes: a randomized controlled trial. [2010.01]
OBJECTIVE: To compare the efficacy of metformin with glyburide for glycemic control in gestational diabetes... CONCLUSION: In this study, the failure rate of metformin was 2.1 times higher than the failure rate of glyburide when used in the management of gestational diabetes (95% confidence interval 1.2-3.9). CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00965991. LEVEL OF EVIDENCE: I.

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Clinical Trials Related to Glyburide and Metformin (Glyburide / Metformin)

AVANDIA With Glyburide In African American And Hispanic Patients With Type 2 Diabetes Not Controlled by Glyburide Alone [Completed]
This study was designed to evaluate the safety and efficacy of AVANDIA (rosiglitazone) (8mg once daily) in African American and Hispanic patients with type 2 diabetes mellitus. As microvascular and macrovascular disease are significant contributors to diabetes morbidity and mortality and previous studies suggest that the thiazolidinedione compounds could have potentially beneficial vascular effects, the effects of rosiglitazone therapy on serum parameters associated with endothelial dysfunction, vascular inflammation and impaired fibrinolysis were examined in this study. Improvement in these parameters suggests that rosiglitazone may provide an additional beneficial vascular effect, apart from its ability to improve glycemic control.

Glyburide Healthy Volunteer Study [Recruiting]
Glyburide is a medication that has been safely used for several decades to treat non-insulin dependent diabetes. This pilot study seeks to support the hypothesis that glyburide, administered at the lowest dose (1. 5 mg/dL daily) to healthy (non-diabetic) subjects is safe both physically and cognitively. The investigators are hopeful that the results of this study will provide the necessary foundation to evaluate this medication's use on a larger scale to determine the feasibility of using glyburide in soldiers either prophylactically or for treatment of brain injury.

A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes. [Completed]
This study will assess the potential pharmacodynamic and potential pharmacokinetic interaction between GK Activator (2) and glyburide, in type 2 diabetes patients not adequately controlled with glyburide as standard prescribed therapy. Patients will enter the study taking a dose of glyburide (10-20mg po daily) as prescribed prior to study start. GK Activator (2) 100mg bid will be added for 5 days. From days 6-12 patients will receive GK Activator (2) monotherapy, and from day 13 GK Activator (2) will be discontinued and glyburide treatment re-started. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Glyburide Healthy Volunteer Study [Recruiting]
Glyburide is a medication that has been safely used for several decades to treat non-insulin dependent diabetes. This pilot study seeks to evaluate whether glyburide, administered at the lowest dose (1. 5 mg/dL daily) to healthy (non-diabetic) subjects is safe both physically and cognitively. The investigators are hopeful that the results of this study will provide the necessary foundation to evaluate this medication's use on a larger scale to determine the feasibility of using glyburide in soldiers either prophylactically or for the treatment of brain injury.

Glyburide (RP-1127) for Traumatic Brain Injury (TBI) [Recruiting]
This is a randomized, double-blind, placebo-controlled, multi-institutional study of IV RP-1127 (Glyburide for Injection) begun within 10 hours of complicated mild, moderate or severe traumatic brain injury (TBI).

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