AMARYL SUMMARY
AMARYL® (glimepiride tablets) is an oral blood-glucose-lowering drug of the sulfonylurea class. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder formulated into tablets of 1-mg, 2-mg, and 4-mg strengths for oral administration.
AMARYL is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin-dependent (Type II) diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled by diet and exercise alone. AMARYL may be used concomitantly with metformin when diet, exercise, and AMARYL or metformin alone do not result in adequate glycemic control.
AMARYL is also indicated for use in combination with insulin to lower blood glucose in patients whose hyperglycemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycemic agent. Combined use of glimepiride and insulin may increase the potential for hypoglycemia.
In initiating treatment for noninsulin-dependent diabetes, diet and exercise should be emphasized as the primary form of treatment. Caloric restriction, weight loss, and exercise are essential in the obese diabetic patient. Proper dietary management and exercise alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. In addition to regular physical activity, 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 AMARYL must be viewed by both the physician and patient as a treatment in addition to diet and exercise and not as a substitute for diet and exercise or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood glucose control on diet and exercise alone may be transient, thus requiring only short-term administration of AMARYL.
During maintenance programs, AMARYL monotherapy should be discontinued if satisfactory lowering of blood glucose is no longer achieved. Judgments should be based on regular clinical and laboratory evaluations. Secondary failures to AMARYL monotherapy can be treated with AMARYL-insulin combination therapy.
In considering the use of AMARYL in asymptomatic patients, it should be recognized that blood glucose control in NIDDM has not definitely been established to be effective in preventing the long-term cardiovascular and neural complications of diabetes. However, the Diabetes Control and Complications Trial (DCCT) demonstrated that control of HbA1c and glucose was associated with a decrease in retinopathy, neuropathy, and nephropathy for insulin-dependent diabetic (IDDM) patients.
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NEWS HIGHLIGHTS
Published Studies Related to Amaryl (Glimepiride)
Pioglitazone vs glimepiride: Differential effects on vascular endothelial function in patients with type 2 diabetes. [2009.07]
OBJECTIVE: The aim of this study was to compare the effect of glimepiride and pioglitazone on endothelial function in patients with type 2 diabetes already on metformin... CONCLUSIONS: In patients with type 2 diabetes already on metformin, addition of pioglitazone as compared to glimepiride, improved endothelial function despite similar glycemic control. The improvement in endothelial function was mainly due to a reduction in insulin resistance.
Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. [2009.02.07]
BACKGROUND: New treatments for type 2 diabetes mellitus are needed to retain insulin-glucose coupling and lower the risk of weight gain and hypoglycaemia. We aimed to investigate the safety and efficacy of liraglutide as monotherapy for this disorder... INTERPRETATION: Liraglutide is safe and effective as initial pharmacological therapy for type 2 diabetes mellitus and leads to greater reductions in HbA(1c), weight, hypoglycaemia, and blood pressure than does glimepiride.
Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin in type 2 diabetes mellitus (LEAD-2 Met). [2008.10.17]
Objective Efficacy and safety of adding liraglutide (a GLP-1 receptor agonist) to metformin were compared with adding placebo or glimepiride to metformin in subjects previously treated with oral antidiabetic (OAD) therapy. Research design and methods This 26-week, double-blind, double-dummy, placebo- and active-controlled, parallel-group trial randomized 1091 subjects (2:2:2:1:2) to once-daily liraglutide (either 0.6, 1.2, or 1.8 mg/day injected subcutaneously), or to placebo, or to glimepiride (4 mg once daily [QD]).
Improvement of glycaemic and lipid profiles with muraglitazar plus metformin in patients with type 2 diabetes: an active-control trial with glimepiride. [2008.09]
The efficacy and safety of muraglitazar versus glimepiride were evaluated in patients with type 2 diabetes. After open-label metformin monotherapy, 1,805 patients received randomised therapy with muraglitazar 2.5 mg or 5 mg or with glimepiride 1 mg in a double-blind 52-week study... Cardiovascular events were similar among groups (~2%), but there was an imbalance of total mortality in favour of glimepiride.
Comparison of pioglitazone vs glimepiride on progression of coronary atherosclerosis in patients with type 2 diabetes: the PERISCOPE randomized controlled trial. [2008.04.02]
CONTEXT: No antidiabetic regimen has demonstrated the ability to reduce progression of coronary atherosclerosis. Commonly used oral glucose-lowering agents include sulfonylureas, which are insulin secretagogues, and thiazolidinediones, which are insulin sensitizers. OBJECTIVE: To compare the effects of an insulin sensitizer, pioglitazone, with an insulin secretagogue, glimepiride, on the progression of coronary atherosclerosis in patients with type 2 diabetes... CONCLUSION: In patients with type 2 diabetes and coronary artery disease, treatment with pioglitazone resulted in a significantly lower rate of progression of coronary atherosclerosis compared with glimepiride. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00225277.
Clinical Trials Related to Amaryl (Glimepiride)
Exenatide Versus Glimepiride in Patients With Type 2 Diabetes [Active, not recruiting]
This study assesses the effects of twice-daily subcutaneous injection exenatide versus
treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell
function.
Fasting Study of Glimepiride Tablets 1 mg to Amaryl® Tablets 1 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's glimepiride 1 mg
tablets to Aventis Amaryl® 1 mg tablets following a single, oral 1 mg (1 x 1 mg) dose
administered under fasting conditions.
Food Study of Glimepiride Tablets 1 mg to Amaryl® Tablets 1 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's glimepiride 1 mg
tablets to Aventis Amaryl® 1 mg tablets following a single, oral 1 mg (1 x 1 mg) dose
administered under fed conditions.
Phase III Study for Glimepiride + Metformin Hydrochloride (Amaryl M) Slow Release (SR) [Completed]
Primary:
To show the equivalence in terms of efficacy glycated hemoglobin (HbA1c) of
glimepiride/metformin slow-release combination tablet (Amaryl M SR 2/500) once daily compared
with fixed-dose glimepiride/metformin combination tablet (Amaryl M 1/250) twice a day on
HbA1c in patients with type 2 Diabetes Mellitus (DM)
Secondary: To compare the following parameters in two treatment arm
- Efficacy; Fasting Plasma Glucose (FPG) and Post-prandial two hours plasma glucose
(PP2h)
- Response rates in terms of HbA1c, FPG
- Patient compliance
Safety:
- episodes of hypoglycemia
- adverse events
- laboratory values including hematology blood chemistry and urinalysis
- vital sign and physical examination
Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia [Active, not recruiting]
This study will look at two FDA approved medications that improve how the pancreas works in
patients with Type 2 Diabetes. In order to understand how these medications work in patients
with diabetes we must first measure the normal response in healthy volunteers without
diabetes. We will be looking at the body's normal physiological response to low blood sugar
and whether this will be modified by these medicationsThe hypothesis would be that
glimepiride induced insulin secretion will be inhibited by hypoglycemia.
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Page last updated: 2009-10-20
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