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)
Comparison of extended-release metformin in combination with a sulfonylurea (glyburide) to sulfonylurea monotherapy in adult patients with type 2 diabetes: a multicenter, double-blind, randomized, controlled, phase III study. [2007.05]
BACKGROUND: Metformin is widely used in the management of type 2 diabetes, either as monotherapy or in combination with other oral antihyperglycemic agents such as sulfonylureas and thiazolidinediones. Combination treatment with metformin and sulfonylurea in patients who failed monotherapy has been reported to be effective in maintaining glycemic control. OBJECTIVE: The purpose for this study was to compare the efficacy and tolerability of extended-release metformin (MER) administered with a sulfonylurea (glyburide) to sulfonylurea monotherapy in patients with type 2 diabetes... CONCLUSIONS: The combination of QD or BID treatment with MER+S was significantly more effective in lowering HbA(1c) and glucose levels than sulfonylurea monotherapy in these adult patients with type 2 diabetes. However, a significant increase in the prevalence of hypoglycemia was observed in the MER+S treatment groups compared with the sulfonylurea monotherapy group.
Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. [2006.12.07]
BACKGROUND: The efficacy of thiazolidinediones, as compared with other oral glucose-lowering medications, in maintaining long-term glycemic control in type 2 diabetes is not known... CONCLUSIONS: The potential risks and benefits, the profile of adverse events, and the costs of these three drugs should all be considered to help inform the choice of pharmacotherapy for patients with type 2 diabetes. (ClinicalTrials.gov number, NCT00279045 [ClinicalTrials.gov].). Copyright 2006 Massachusetts Medical Society.
Investigation of the pharmacokinetic and pharmacodynamic interactions between memantine and glyburide/metformin in healthy young subjects: a single-center, multiple-dose, open-label study. [2005.10]
BACKGROUND: The high prevalence rates of both Alzheimer's disease (AD) and type 2 diabetes mellitus in the elderly population suggest that concomitant pharmacotherapy is likely. Given the renal tubular transport and extensive urinary excretion of memantine and metformin, it was of interest to assess the pharmacokinetic and pharmacodynamic interaction with glyburide/metformin. OBJECTIVE: The primary goal of this study was to determine whether an in vivo pharmacokinetic or pharmacodynamic interaction exists between memantine (an uncompetitive, moderate-affinity, N-methyl-D-aspartate receptor antagonist with fast blocking/unblocking kinetics that is available in the United States for moderate to severe AD) and glyburide/metformin (a combination pharmacotherapy formulation approved for glycemic control in patients with type 2 diabetes mellitus)... CONCLUSIONS: No pharmacokinetic interactions between memantine and glyburide/metformin were detected in this study of healthy young volunteers. Memantine had no effect on the pharmacodynamic activities of glyburide and metformin, and the drug combination was well tolerated in this population.
PRESERVE-beta: two-year efficacy and safety of initial combination therapy with nateglinide or glyburide plus metformin. [2005.09]
CONCLUSIONS: Similar good glycemic control can be maintained for 2 years with either treatment regimen, but nateglinide/metformin may represent a safer approach to initial combination therapy.
Use of a claims-based active drug safety surveillance system to assess the risk of acute pancreatitis with exenatide or sitagliptin compared to metformin or glyburide. [2009.04]
CONCLUSIONS: These data do not provide evidence for an association of acute pancreatitis among initiators of exenatide or sitagliptin compared to met/gly initiators. These results are limited by the data available in an administrative, healthcare database.
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.
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.
Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients [Completed]
The purpose of this study is to compare the vascular effects of two commonly used diabetes
medications, rosiglitazone and glyburide in type 2 diabetic patients.
Effect of GlucoNorm vs Glyburide on Post-Prandial Hyperglycemia in Elderly Subjects With Type 2 Diabetes [Recruiting]
The results from the DECODE Study have shown that postprandial (1 - 2 hours after a meal)
hyperglycemia (elevated blood sugar) is more common in elderly people with diabetes than
younger people with diabetes and is the best predictor of the development of complications.
The DECODE Study involved 6941 people who already had diabetes and 702 who did not have
diabetes. Diabetes is diagnosed when the blood sugar 1st thing in the morning is over 7. 0
mmol/L. The DECODE Study showed that people at risk for diabetes can have a normal blood
sugar 1st thing in the morning but have a high blood sugar 2 hours after a meal and that
these people are at risk for developing heart disease and other complications of diabetes.
These people would not be identified as at risk if only a fasting blood sugar is done.
Studies in younger people with diabetes have shown that after a meal, insulin levels are
more like a person without diabetes and glucose (blood sugar) levels are lower with
GlucoNorm than with Glyburide. There is no data available that demonstrates this in elderly
people with type 2 diabetes.
You have been invited to participate in this study because you have type 2 diabetes
controlled by diet and/or exercise or metformin only and are over 65 years of age.
The purpose of this study is to determine whether GlucoNorm has a greater effect than
Glyburide on insulin levels and glucose (blood sugar) levels after a meal in elderly people
with type 2 diabetes who control their diabetes with diet and exercise.
Interplay Between Organic Anion Transporting Polypeptide (OATP) Transporters Transporters and CYP2C9 in Glyburide Pharmacokinetics (PK) [Not yet recruiting]
The purpose of this study is to investigate if the drugs rifampin and fluconazole when given
together increase the concentrations in the body of the oral diabetes medication glyburide.
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