SUMMARY
Micronized Glyburide Tablets
1.5 mg, 3 mg and 6 mg
Micronized glyburide 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 micronized glyburide tablets of 1.5, 3 and 6 mg strengths for oral administration.
Micronized glyburide 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 micronized glyburide 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 micronized glyburide.
During maintenance programs, micronized glyburide 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 micronized glyburide 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 Micronized Glyburide (Glyburide)
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.
Effect of repaglinide versus glyburide on postprandial glucose and insulin values in elderly patients with type 2 diabetes. [2011.01]
BACKGROUND: studies in younger patients with diabetes have shown that insulin profiles are more physiologic and postprandial glucose levels are lower with repaglinide than with glyburide. We conducted this study to determine if the differences in insulin/glucose profiles between repaglinide and glyburide were similar or different in the elderly... CONCLUSIONS: we conclude that repaglinide results in a more physiologic insulin profile and less frequent hypoglycemia than glyburide in the elderly.
Clinical Trials Related to Micronized Glyburide (Glyburide)
Effects of Micronized Trans-resveratrol Treatment on Polycystic Ovary Syndrome (PCOS) Patients [Not yet recruiting]
The purpose of this study is to determine whether micronized trans-resveratrol improves
clinical (excessive hair, menstrual cycle), endocrine (androgens)and metabolic (lipids,
markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).
Evaluation of Pharmacokinetic Interaction Between Micronized Fenofibrate and Pitavastatin [Recruiting]
To develop combination product of micronized fenofibrate plus pitavastatin, we would like to
evaluate pharmacokinetic drug interaction by comparing the steady-state pharmacokinetic
characteristics of each arms after repeated administrating Lipilfen cap. 160mg(micronized
fenofibrate 160mg)by Dae Woong Pharma. and Livaro tab. 2mg (pitavastatin Ca 2mg) by Joong
Wae Pharm. through 3 period by separately or combinedly.
Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms [Recruiting]
The purpose of this study is to test whether a oral micronized progesterone reduces the
score, number and severity of hot flushes and night sweats in perimenopausal women. Oral
micronized progesterone is molecularly identical to human progesterone, a steroid hormone.
It is sold by prescription for use to prevent endometrial cancer in women taking estrogen in
menopause. This research study will test whether progesterone reduces perimenopausal hot
flushes and night sweats. It will also test whether progesterone improves sleep problems,
mood and health-related quality of life.
Vasomotor Symptoms (VMS) Progesterone Study: Vasomotor Symptoms and Endothelial Function - Trial of Oral Micronized Progesterone [Recruiting]
The primary purpose of this study is to determine the effects of a full dose (300 mg at hs)
of oral micronized progesterone (OMP) on vasomotor symptoms [VMS] (hot flushes/night
sweats), on forearm blood flow and on lipid levels and blood pressure in menopausal women
without cardiovascular disease and with moderate to severe VMS.
The hypotheses are that progesterone will improve hot flushes, increase
endothelium-dependent forearm blood flow and will decrease blood pressure without change in
lipid levels.
Progestagens for the Tertiary Prophylaxis of Preterm Delivery [Recruiting]
Objective: This trial would evaluate the clinical effectiveness of Progesterone(P) and
17-hydroxy Progesterone (17P) in reducing PTD, in symptomatic women at risk because of
cervical shortening, in the present pregnancy.
Main outcome: Delivery before 37 weeks.
Secondary outcomes: Gestational age at delivery, Delivery <32, <35 wks, hospital admissions
before delivery, birth-weight centile, NICU admission, days of NICU admission, days of
oxygen supply, composite neonatal complications, congenital neonatal malformations and
anomalies.
Allocated treatments will be:
Group A: 17P 341 mg i. m./weekly (Lentogest, AMSA, Italy); Group B: micronized P 200 mg per
vagina /day (Utrogestan, Besins Healthcare, Belgium) Group C: no treatment, clinical
observation
Concomitant treatments: Iron and folic acid supplementation, and Betamethasone (12 mg
repeated once 24 hours apart) will be permitted. Is not allowed the treatment with
tocolytics per os. Any treatment will be recorded.
Duration: The period of enrollment is 15 months. Cases not randomized by a clinical unit
will be competitively assigned later. Results are expected 20-24 months from starting.
Sample Size: hypothesizing a risk of PTD = 0. 30 efficacy is defined as a reduction to 50%
(risk = 0. 15). With a test potency = 0. 80 and alpha = 0. 025 study needs to enrol 160
patients/arm, with a total of 480 patients.
Data analysis: Methodological Unit will assign randomized treatment through a web site and
it will collect data through the same way.
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