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Amaryl (Glimepiride) - Summary

 
 



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.


See all Amaryl indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Amaryl (Glimepiride)

Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomized, 24-week, double-blind, placebo-controlled trial. [2011.10]
AIMS: Progressive deterioration of glycaemic control in type 2 diabetes mellitus (T2DM) often requires treatment intensification. Dapagliflozin increases urinary glucose excretion by selective inhibition of renal sodium-glucose cotransporter 2 (SGLT2). We assessed the efficacy, safety and tolerability of dapagliflozin added to glimepiride in patients with uncontrolled T2DM... CONCLUSIONS: Dapagliflozin added to glimepiride in patients with T2DM uncontrolled on sulphonylurea monotherapy significantly improved HbA1c, reduced weight and was generally well tolerated, although events suggestive of genital infections were reported more often in patients receiving dapagliflozin. (c) 2011 Blackwell Publishing Ltd.

Exenatide or glimepiride added to metformin on metabolic control and on insulin resistance in type 2 diabetic patients. [2011.09]
The aim of this study was to evaluate the effect of exenatide compared to glimepiride on body weight, glycemic control and insulin resistance in type 2 diabetic patients taking metformin. One hundred and eleven patients with uncontrolled type 2 diabetes mellitus and intolerant to metformin at the highest dosages (2500-3000 mg/day) were enrolled in this study...

PIOfix-study: effects of pioglitazone/metformin fixed combination in comparison with a combination of metformin with glimepiride on diabetic dyslipidemia. [2011.06]
CONCLUSIONS: With comparable glycemic control, the fixed PM combination was more efficacious on HDL cholesterol improvement than the GM combination. Additional positive effects were observed for biomarkers of lipid metabolism, beta-cell function, activity of the visceral adipose tissue, and chronic systemic inflammation.

Liraglutide, a once-daily human glucagon-like peptide 1 analogue, provides sustained improvements in glycaemic control and weight for 2 years as monotherapy compared with glimepiride in patients with type 2 diabetes. [2011.04]
AIMS: Most treatments for type 2 diabetes fail over time, necessitating combination therapy. We investigated the safety, tolerability and efficacy of liraglutide monotherapy compared with glimepiride monotherapy over 2 years... CONCLUSION: Liraglutide monotherapy for 2 years provides significant and sustained improvements in glycaemic control and body weight compared with glimepiride monotherapy, at a lower risk of hypoglycaemia. (c) 2011 Blackwell Publishing Ltd.

Comparison of the efficacy of glimepiride, metformin, and rosiglitazone monotherapy in korean drug-naive type 2 diabetic patients: the practical evidence of antidiabetic monotherapy study. [2011.02]
BACKGROUND: Although many anti-diabetic drugs have been used to control hyperglycemia for decades, the efficacy of commonly-used oral glucose-lowering agents in Korean type 2 diabetic patients has yet to be clearly demonstrated... CONCLUSION: The efficacy of glimepiride, metformin, and rosiglitazone as antidiabetic monotherapies in drug-naive Korean type 2 diabetic patients was similar in the three groups, with no statistical difference. This study is the first randomized controlled trial to evaluate the efficacy of commonly-used oral hypoglycemic agents in Korean type 2 diabetic patients. An additional subgroup analysis is recommended to obtain more detailed information.

more studies >>

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

ADIponectin and Asymmetric Dimethylarginine (ADMA) Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination [Recruiting]
Primary Objective:

To evaluate the change in plasma levels of adiponectin and Asymmetric Dimethylarginine (ADMA) in type 2 diabetes patients after 12 weeks of treatment with Amaryl-M

Secondary Objectives:

1. To assess the role of Amaryl-M in the change of plasma levels of adiponectin and ADMA in type 2 diabetes patients after 8 weeks of therapy

2. To evaluate the brachial-ankle pulse wave velocity (baPWV) change after 8 and 12 weeks of therapy with Amaryl-M

3. To evaluate the efficacy of Amaryl-M in the improvement of patients glycemic level (Fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c))

4. To evaluate the change of Tumor Necrosis Factor - Alfa (TNF-Alfa) after 12 weeks of

therapy with Amaryl-M

5. To evaluate the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) change after 12 weeks of therapy with Amaryl-M

6. To evaluate the HOMA-╬▓ change after 12 weeks of therapy with Amaryl-M

7. To evaluate the relationship between adiponectin and ADMA level with FBG or HbA1c level

more trials >>

Reports of Suspected Amaryl (Glimepiride) Side Effects

Hypoglycaemia (89)Hyperglycaemia (25)Renal Failure (23)Blood Glucose Increased (21)Altered State of Consciousness (18)Intentional Overdose (13)Fall (13)Interstitial Lung Disease (13)Arthralgia (13)Weight Decreased (12)more >>


Page last updated: 2011-12-09

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