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)
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.
Lack of an effect of pioglitazone or glipizide on lipoprotein-associated phospholipase A2 in type 2 diabetes. [2007.03]
OBJECTIVE: To study the effects of pioglitazone, a peroxisome proliferator-activated receptor-y agonist with vascular beneficial effects, and glipizide, an insulin secretagogue, on novel inflammatory vascular risk markers in subjects with and without type 2 diabetes... CONCLUSION: Type 2 diabetes is associated with elevated concentrations of the novel vascular risk marker LpPLA2 and inflammatory risk markers e-selectin and VCAM-1. Neither pioglitazone nor glipizide significantly altered LpPLA2, VCAM-1, or highly sensitive C-reactive protein levels after 12 weeks of therapy. In study subjects with type 2 diabetes, e-selectin concentrations declined significantly with pioglitazone therapy, whereas ICAM-1 concentrations decreased significantly with glipizide therapy.
Sustained-release versus immediate-release glipizide for treatment of type 2 diabetes mellitus in chinese patients: A randomized, double-blind, double-dummy, parallel-group, 12-week clinical study. [2006.09]
BACKGROUND: Few data exist that have compared sulfonylurea formulations in differing ethnic populations. Most studies of sulfonylureas have been performed in white patients with type 2 diabetes mellitus. OBJECTIVE: The aim of this study was to compare the efficacy and tolerability of a sustained-release glipizide (GSR) formulation with those of immediate-release glipizide (GIR) in Chinese patients with type 2 diabetes mellitus... CONCLUSION: In this small study, treatment with oral GSR (10 mg QD) was not significantly different from that of treatment with GIR (5 mg BID) with respect to short-term (12 weeks) FPG and HbA(1c) reductions in these ethnic Chinese adults with type 2 diabetes mellitus receiving treatment with a sulfonylurea.
Long-term beneficial effects of glipizide treatment on glucose tolerance in subjects with impaired glucose tolerance. [2006.06]
AIMS: To assess the efficacy and long-term effects of glipizide treatment on glucose and insulin metabolism in individuals with impaired glucose tolerance (IGT)... CONCLUSIONS: Short-term treatment with glipizide improves glucose and insulin metabolism in subjects with IGT primarily by improving insulin sensitivity mediated by lowering glucose toxicity, thereby providing the beta cells rest. Larger studies are needed to establish whether these effects are sufficient to prevent progression to manifest type 2 diabetes and associated cardiovascular morbidity in subjects at increased risk of developing type 2 diabetes.
Effects of pioglitazone versus glipizide on body fat distribution, body water content, and hemodynamics in type 2 diabetes. [2006.03]
CONCLUSIONS: When pioglitazone and glipizide are given in doses sufficient to achieve equivalent glycemic control in people with type 2 diabetes, pioglitazone increases total body water, thereby accounting for the majority of weight gain, tended to decrease visceral and abdominal fat content and blood pressure, and reduces systemic vascular resistance.
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.
Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Subjects With Type 2 Diabetes Mellitus [Recruiting]
The purpose of this study is to determine the safety and effectiveness of adding alogliptin
compared to glipizide with metformin in diabetic subjects.
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.
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Page last updated: 2007-08-04
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