MICRONASE SUMMARY
Micronase®
glyburide tablets, USP
MICRONASE Tablets contain glyburide, which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide is a white, crystalline compound, formulated as MICRONASE Tablets of 1.25, 2.5, and 5 mg strengths for oral administration.
MICRONASE Tablets are indicated as an adjunct to diet to lower the blood glucose in patients with non-insulin-dependent diabetes mellitus (Type II) whose hyperglycemia cannot be satisfactorily controlled by diet alone.
Glyburide may be used concomitantly with metformin when diet and glyburide or diet and metformin alone do not result in adequate glycemic control (see metformin insert).
In initiating treatment for non-insulin-dependent diabetes, diet should be emphasized as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. The importance of regular physical activity should also be stressed, and cardiovascular risk factors should be identified and corrective measures taken where possible. If this treatment program fails to reduce symptoms and/or blood glucose, the use of an oral sulfonylurea or insulin should be considered. Use of MICRONASE must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitution or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood glucose control on diet alone may be transient, thus requiring only short-term administration of MICRONASE.
During maintenance programs, MICRONASE should be discontinued if satisfactory lowering of blood glucose is no longer achieved. Judgment should be based on regular clinical and laboratory evaluations.
In considering the use of MICRONASE in asymptomatic patients, it should be recognized that controlling blood glucose in non-insulin-dependent diabetes has not been definitely established to be effective in preventing the long-term cardiovascular or neural complications of diabetes.
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NEWS HIGHLIGHTS
Published Studies Related to Micronase (Glyburide)
Impact of rosiglitazone and glyburide on nitrosative stress and myocardial blood flow regulation in type 2 diabetes mellitus. [2009.07]
Cardiovascular disease, the leading cause of death in patients with type 2 diabetes mellitus (T2DM), is usually preceded by endothelial dysfunction and altered myocardial blood flow (MBF) regulation... Rosiglitazone, but not glyburide, ameliorated markers of nitrosative stress and inflammation in subjects with T2DM without impairing myocardial perfusion.
Neonatal adiposity following maternal treatment of gestational diabetes with glyburide compared with insulin. [2009.05]
OBJECTIVE: We hypothesized that body composition would be similar among neonates of women with gestational diabetes (GDM) treated with glyburide or insulin... CONCLUSION: There was no difference in neonatal adiposity in infants of women treated for GDM with glyburide or insulin.
Evaluation of pharmacokinetic and pharmacodynamic interaction between the dipeptidyl peptidase IV inhibitor vildagliptin, glyburide and pioglitazone in patients with Type 2 diabetes. [2008.07]
Background: Vildagliptin is a selective inhibitor of dipeptidyl peptidase IV (DPP-4) that improves glycemic control and pancreatic b-cell function in patients with Type 2 diabetes. Vildagliptin may be an appropriate agent to combine with other antihyperglycemic agents in patients requiring combination therapy to achieve optimal glycemic control...
Beneficial effects of GLP-1 on endothelial function in humans: dampening by glyburide but not by glimepiride. [2007.11]
Sulfonylureas (SU) with glucagon-like peptide-1 (GLP-1)-based therapy are an emerging therapeutic combination for type 2 diabetes...
Glyburide for the treatment of gestational diabetes. A critical appraisal. [2007.07]
The clinical experience with glyburide treatment of GDM has moved ahead of the science...
Clinical Trials Related to Micronase (Glyburide)
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.
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.
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.
Glyburide Compared to Insulin in the Management of White's Classification A2 Gestational Diabetes [Recruiting]
The purpose of this study is to determine whether the oral administration of glyburide is as
effective as insulin in the treatment of gestational diabetes.
1. SYNOPSIS: Infants born to mothers with gestational diabetes(GDM) are at risk for a
variety of adverse perinatal outcomes including macrosomia with subsequent birth trauma
and cesarean delivery, neonatal hypoglycemia, polycythemia, jaundice, hypocalcemia,
respiratory depression and newborn intensive care unit admission. These adverse
outcomes are thought to be related to the degree of maternal hyperglycemia during
pregnancy. Women with GDM are typically treated with insulin to lower blood glucose
levels to as near-normal as possible. A single randomized trial has suggested that the
oral sulfonylurea, glyburide is a clinically effective and safe alternative to insulin
therapy.
2. Many obstetric care providers have adopted the use of glyburide in the routine
management of gestational diabetes. The American College of Obstetrics and Gynecology
and the American Diabetic Association both state that further studies are needed in a
larger patient population before the use of newer oral hypoglycemic agents can be
supported for use in pregnancy.
3. STATUS: Previous studies have demonstrated that there is no maternal-fetal transfer of
glyburide and when compared to insulin is an effective alternative to insulin.
Additionally, a published cost analysis concluded that glyburide is significantly less
costly than insulin for the treatment of GDM. The benefits of an oral agent for the
management of gestational diabetes include less discomfort for the patient in drug
administration, lower requirement for patient education in the administration of
injectable medications and less chance of error in dosing. Our study population is
more ethnically diverse and our incidence of large for gestational age infants is lower
than in the largely Hispanic population studied by Langer et al. Many obstetricians,
including ourselves, apply different criteria than Langer for diagnosing gestational
diabetes , and for deciding when to institute insulin therapy. It is our goal to
confirm the prior single study concerning the safety and efficacy of glyburide in
reducing the complications of GDM utilizing a more ethnically diverse population with
more realistic goals in glycemic control. To this end we will add to the medical
literature supporting this alternative therapy to insulin.
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