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Glucotrol XL (Glipizide Extended Releases) - Summary

 
 



GLUCOTROL XL SUMMARY

GLUCOTROL XL®
(glipizide)
Extended Release Tablets

Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class.

GLUCOTROL XL is indicated as an adjunct to diet for the control of hyperglycemia and its associated symptomatology in patients with type 2 diabetes formerly known as non-insulin-dependent diabetes mellitus (NIDDM) or maturity-onset diabetes, after an adequate trial of dietary therapy has proved unsatisfactory. GLUCOTROL XL is indicated when diet alone has been unsuccessful in correcting hyperglycemia, but even after the introduction of the drug in the patient's regimen, dietary measures should continue to be considered as important. In 12 week, well-controlled studies there was a maximal average net reduction in hemoglobin A1C of 1.7% in absolute units between placebo-treated and GLUCOTROL XL-treated patients.

In initiating treatment for type 2 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 blood glucose and symptoms of hyperglycemia. The importance of regular physical activity should also be stressed, 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 should be considered. If additional reduction of symptoms and/or blood glucose is required, the addition of insulin to the treatment regimen should be considered. Use of GLUCOTROL XL must be viewed by both the physician and patient as a treatment in addition to diet, and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood-glucose control on diet alone also may be transient, thus requiring only short-term administration of glipizide.

Some patients fail to respond initially or gradually lose their responsiveness to sulfonylurea drugs, including GLUCOTROL XL. In these cases, concomitant use of GLUCOTROL XL with other oral blood-glucose-lowering agents can be considered. Other approaches that can be considered include substitution of GLUCOTROL XL therapy with that of another oral blood-glucose-lowering agent or insulin. GLUCOTROL XL should be discontinued if it no longer contributes to glucose lowering. Judgment of response to therapy should be based on regular clinical and laboratory evaluations.

In considering the use of GLUCOTROL XL in asymptomatic patients, it should be recognized that controlling blood glucose in type 2 diabetes has not been definitely established to be effective in preventing the long-term cardiovascular or neural complications of diabetes. However, in insulin-dependent diabetes mellitus controlling blood glucose has been effective in slowing the progression of diabetic retinopathy, nephropathy, and neuropathy.


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NEWS HIGHLIGHTS

Published Studies Related to Glucotrol XL (Glipizide)

Effects of metformin versus glipizide on cardiovascular outcomes in patients with type 2 diabetes and coronary artery disease. [2013]
CONCLUSIONS: Treatment with metformin for 3 years substantially reduced major

Effects of Metformin Versus Glipizide on Cardiovascular Outcomes in Patients With Type 2 Diabetes and Coronary Artery Disease. [2012]
OBJECTIVEThe two major classes of antidiabetic drugs, sulfonylureas and metformin, may differentially affect macrovascular complications and mortality in diabetic patients. We compared the long-term effects of glipizide and metformin on the major cardiovascular events in type 2 diabetic patients who had a history of coronary artery disease (CAD).RESEARCH DESIGN AND METHODSThis study is a multicenter, randomized, double-blind, placebo-controlled clinical trial...

Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. [2011.09]
CONCLUSIONS: Despite similar 52-week glycemic efficacy, dapagliflozin reduced weight and produced less hypoglycemia than glipizide in type 2 diabetes inadequately controlled with metformin. Long-term studies are required to further evaluate genital and urinary tract infections with SGLT2 inhibitors.

Meal fat storage in subcutaneous adipose tissue: comparison of pioglitazone and glipizide treatment of type 2 diabetes. [2010.10]
Treatment of type 2 diabetes (T2DM) with pioglitazone changes abdominal fat in the opposite direction as treatment with glipizide. To determine whether these two medications affect adipose tissue meal fatty acid storage differently we studied 19 T2DM treated with either pioglitazone (n = 8) or glipizide (n = 11) and 11 non-DM control subjects matched for age, BMI, abdominal and leg fat...

Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. [2007.03]
AIM: To compare the efficacy and safety of sitagliptin vs. glipizide in patients with type 2 diabetes and inadequate glycaemic control [haemoglobin A(1c) (HbA(1c)) > or = 6.5 and < or = 10%] on metformin monotherapy... CONCLUSIONS: In this study, the addition of sitagliptin compared with glipizide provided similar HbA(1c)-lowering efficacy over 52 weeks in patients on ongoing metformin therapy. Sitagliptin was generally well tolerated, with a lower risk of hypoglycaemia relative to glipizide and with weight loss compared with weight gain with glipizide.

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Clinical Trials Related to Glucotrol XL (Glipizide)

Bioequivalence Study Of Glucotrol XL 2.5 Mg Tablets [Completed]
The objective of this study is to determine the bioequivalence of Glipizide GITS (Glucotrol XL) 2. 5 mg tablets manufactured at the Brooklyn, New York facility versus tablets manufactured at the facility in Barceloneta, Puerto Rico.

Efficacy and Safety Study of Alogliptin Compared to Glipizide in Elderly Diabetics [Recruiting]
The purpose of this study is to evaluate the efficacy and safety of alogliptin compared to glipizide in elderly diabetic patients who have not received treatment or are on a single oral medication.

Sitagliptin vs Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency [Recruiting]
The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in patients with moderate and severe renal insufficiency.

Sitagliptin vs Glipizide in Patients With Type 2 Diabetes Mellitus and End-Stage Renal Disease [Recruiting]
The purpose of the study is to compare sitagliptin and glipizide in lowering blood sugar in patients with end-stage renal disease on dialysis.

Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients [Recruiting]
This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.

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Reports of Suspected Glucotrol XL (Glipizide) Side Effects

Blood Glucose Increased (19)Malaise (18)Drug Ineffective (14)Cardiac Disorder (11)Diabetes Mellitus (10)Fall (10)Blood Cholesterol Increased (9)Rash (9)Weight Increased (8)Memory Impairment (8)more >>


Page last updated: 2014-11-30

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