Comparative Efficacy of a Once-Daily Controlled-Release Formulation of Glipizide and Immediate-Release Glipizide in Patients With NIDDM

Berelowitz, Michael; Fischette, Christine T.; Cefalu, William T.; Schade, David S.; Sutfin, T A; Kourides, Ione A.

doi:10.2337/diacare.17.12.1460

Cited by 48 publications

(21 citation statements)

References 3 publications

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“…Our study has confirmed these findings in showing that once-daily glipizide GITS therapy achieves the same degree of glycemic control as twice-daily administration of immediate-release glipizide despite their markedly different plasma concentration-time profiles. As another study, which was longer in duration, showed significantly lower fasting insulin levels, 9 lower fasting insulin may be the reason why there is no weight gain in long-term studies with glipizide GITS therapy.…”

Section: Comparison Of Extended-and Immediate-release Glipizidementioning

confidence: 89%

Pharmacokinetics and Pharmacodynamics of Extended‐Release Glipizide GITS Compared with Immediate‐Release Glipizide in Patients with Type II Diabetes Mellitus

Chung

Kourides

Canovatchel

et al. 2002

The Journal of Clinical Pharma

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This study was designed to compare the pharmacokinetic and short-term pharmacodynamic profile of extended-release glipizide GITS (Glucotrol XL) given in a dosage of 20 mg once daily with that of immediate-release glipizide (Glucotrol) 10mg twice daily in patients with type II diabetes mellitus. In an open-label, randomized, two-way crossover study, each glipizide formulation was administered for 5 days. Serial blood samples were drawn at baseline and on the 5th day of each treatment phase for measurement of glipizide, glucose, insulin, and C-peptide concentrations. At steady state, the mean Cmax after immediate-release glipizide was significantly greater than after glipizide GITS, and the tmax was considerably shorter. Although the mean Cmin with glipizide GITS was about 80% higher than with immediate-release glipizide, the mean AUC0-24 was significantly lower. Despite the lower plasma concentrations with glipizide GITS in this short-term study, the two formulations had similar effects on serum concentrations of glucose, insulin, and C-peptide. The absence of a pronounced peak plasma concentration with the GITS formulation might confer advantages in terms of maintaining clinical effectiveness and reducing the potential to cause adverse effects.

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Section: Comparison Of Extended-and Immediate-release Glipizidementioning

confidence: 89%

Pharmacokinetics and Pharmacodynamics of Extended‐Release Glipizide GITS Compared with Immediate‐Release Glipizide in Patients with Type II Diabetes Mellitus

Chung

Kourides

Canovatchel

et al. 2002

The Journal of Clinical Pharma

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“…Glipizide sustained release formulation is significantly more effective than the immediate release formulation of glipizide in reducing fasting plasma glucose levels and side effects. 30 Formulation of glipizide as mucoadhesive sustained release dosage form could also exhibit a decrease in side effects.…”

Section: In Vivo Studymentioning

confidence: 99%

Formulation and evaluation of mucoadhesive glipizide microspheres

Patel¹,

Patel²,

Amin

et al. 2005

AAPS PharmSciTech

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The purpose of this research was to formulate and systematically evaluate in vitro and in vivo performances of mucoadhesive microspheres of glipizide. Glipizide microspheres containing chitosan were prepared by simple emulsification phase separation technique using glutaraldehyde as a cross-linking agent. Results of preliminary trials indicate that volume of cross-linking agent, time for cross-linking, polymer-to-drug ratio, and speed of rotation affected characteristics of microspheres. Microspheres were discrete, spherical, and free flowing. The microspheres exhibited good mucoadhesive property in the in vitro wash-off test and also showed a high percentage drug entrapment efficiency. A 3 2 full factorial design was employed to study the effect of independent variables, polymer-to-drug ratio (X 1 ), and stirring speed (X 2 ) on dependent variables percentage mucoadhesion, t 80 , drug entrapment efficiency, and swelling index. The best batch exhibited a high drug entrapment efficiency of 75% and a swelling index of 1.42; percentage mucoadhesion after 1 hour was 78%. The drug release was also sustained for more than 12 hours. The polymer-to-drug ratio had a more significant effect on the dependent variables. In vivo testing of the mucoadhesive microspheres to albino Wistar rats demonstrated significant hypoglycemic effect of glipizide.

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“…Glipizide gastrointestinal therapeutic system (GITS), a controlledrelease sulphonylurea, was introduced [5]. A dose of 5 mg was administered for 2 days, then 10 mg; insulin was simultaneously slowly withdrawn over a period of 5 days.…”

mentioning

confidence: 99%

The identification of a R201H mutation in KCNJ11, which encodes Kir6.2, and successful transfer to sustained-release sulphonylurea therapy in a subject with neonatal diabetes: evidence for heterogeneity of beta cell function among carriers of the R201H mutation

et al. 2005

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Comparative Efficacy of a Once-Daily Controlled-Release Formulation of Glipizide and Immediate-Release Glipizide in Patients With NIDDM

Cited by 48 publications

References 3 publications

Pharmacokinetics and Pharmacodynamics of Extended‐Release Glipizide GITS Compared with Immediate‐Release Glipizide in Patients with Type II Diabetes Mellitus

Pharmacokinetics and Pharmacodynamics of Extended‐Release Glipizide GITS Compared with Immediate‐Release Glipizide in Patients with Type II Diabetes Mellitus

Formulation and evaluation of mucoadhesive glipizide microspheres

The identification of a R201H mutation in KCNJ11, which encodes Kir6.2, and successful transfer to sustained-release sulphonylurea therapy in a subject with neonatal diabetes: evidence for heterogeneity of beta cell function among carriers of the R201H mutation

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