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Glynase (Glyburide) - Summary



GLYNASE PresTab Tablets contain micronized (smaller particle size) glyburide, which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide is a white, crystalline compound, formulated as GLYNASE PresTab Tablets of 1.5, 3, and 6 mg strengths for oral administration.

GLYNASE PresTab 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 GLYNASE PresTab 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 GLYNASE PresTab.

During maintenance programs, GLYNASE PresTab 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 GLYNASE PresTab 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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Published Studies Related to Glynase (Glyburide)

Glyburide is associated with attenuated vasogenic edema in stroke patients. [2014]
is not known... CONCLUSIONS: Several surrogate markers of vasogenic edema appear to be reduced in

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.

Nateglinide provides tighter glycaemic control than glyburide in patients with Type 2 diabetes with prevalent postprandial hyperglycaemia. [2011.05]
AIMS: Postprandial hyperglycaemia in patients with Type 2 diabetes mellitus has been linked to the development of cardiovascular disease. This study compared the effects of mealtime (thrice-daily) nateglinide with once-daily glyburide on postprandial glucose levels in patients with Type 2 diabetes and postprandial hyperglycaemia... CONCLUSIONS: Nateglinide leads to greater reductions in postprandial glucose excursions and is associated with a lower risk of hypoglycaemia than glyburide in this selected population of patients with Type 2 diabetes. (c) 2011 The Authors. Diabetic Medicine (c) 2011 Diabetes UK.

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Clinical Trials Related to Glynase (Glyburide)

Efficacy and Safety of TAK-559 Combined With Glyburide in Treating Subjects With Type 2 Diabetes Mellitus. [Terminated]
The purpose of this study is to determine the safety and efficacy of TAK-559, once daily (QD), combined with glyburide in treating Type 2 Diabetes.

A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Glyburide in Healthy Volunteers [Completed]
The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754) affect the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of a single dose of glyburide.

Glyburide Healthy Volunteer Study [Completed]
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) [Active, not 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).

Glyburide and Metformin for the Treatment of Gestational Diabetes Mellitus. Systematic Review [Completed]
Since the publication in the New England Journal of Medicine (NEJM) in 2000 of the Langer's trial comparing glyburide vs insulin in the treatment of gestational diabetes mellitus (GDM), additional studies of oral agents for the treatment of GDM have been published (observational, randomized controlled trials (RCT), and trials using other drugs like metformin). Some meta-analysis to summarize the evidence have been published: Nicholson 2009 (including 4 RCT addressing different drugs), Dhulkotia 2010 (including 6 RCT addressing different drugs, the meta-analysis combining all drugs altogether), Gui 2013 (including 5 RCT addressing metformin vs insulin). Oral agents are increasingly used for the treatment of GDM. Investigators aim to update the evidence on RCTs comparing glyburide and metformin vs insulin or between them and summarize this evidence using meta-analysis tools. Specifically, investigators aim at producing distinct meta-analyses for each one of the three drug comparisons. This information is not available in the literature since the most recent systematic reviews specifically dealing on oral agents for the treatment of GDM have addressed a single drug comparison (Gui 2013) or have combined different drug comparisons into a single meta-analysis (Dhulkotia 2010)

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Reports of Suspected Glynase (Glyburide) Side Effects

Death (3)Dyspnoea (3)Glaucoma (1)Nasopharyngitis (1)Cardiac Failure Congestive (1)Blood Glucose Increased (1)Pneumonia (1)Breast Cancer Female (1)

Page last updated: 2015-08-10

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