Efficacy, Safety, and Dose-Response Characteristics of Glipizide Gastrointestinal Therapeutic System on Glycemic Control and Insulin Secretion in NIDDM: Results of two multicenter, randomized, placebo-controlled clinical trials

Simonson, Donald C.; Kourides, Ione A.; Feinglos, Mark N.; Shamoon, Harry; Fischette, Christine T.

doi:10.2337/diacare.20.4.597

Cited by 127 publications

(60 citation statements)

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“…However, several studies have demonstrated that the maximum effective doses of sulfonylureas are much lower than the recommended maximum daily dose [24,25]. Consistent with these reports, the daily dose of each sulfonylurea in the present study was found to be lower in patients with HbA1c levels <6.5% compared with patients with HbA1c levels ≥8.0% (Table 1).…”

Section: Acknowledgementssupporting

confidence: 82%

Present status of sulfonylurea treatment for type 2 diabetes in Japan: Second report of a cross-sectional survey of 15,652 patients

Arai¹,

Matoba²,

Hirao³

et al. 2010

Endocr J

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Section: Acknowledgementssupporting

confidence: 82%

Present status of sulfonylurea treatment for type 2 diabetes in Japan: Second report of a cross-sectional survey of 15,652 patients

Arai¹,

Matoba²,

Hirao³

et al. 2010

Endocr J

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“…In a similar study, a reduction in FBG levels by 42 mg/dl (25%) and HbA1c levels of 1.8% with glipizide therapy was reported by Testa et al 45 In another study, reduction in FBG level by 57-74 mg/dl and in HbA1c levels of 1.5-1.82 % after 3-5 month treatment with glipizide have been observed. 46 Our study showed similar decrease in FBG levels, but lesser decrease in HbA1c levels.…”

Section: Glycaemic Controlsupporting

confidence: 80%

Comparative evaluation of glipizide and fenugreek (Trigonella foenum-graecum) seeds as monotherapy and combination therapy on glycaemic control and lipid profile in patients with type 2 diabetes mellitus

Singh

Rai

Mahajan

2016

Int J Basic Clin Pharmacol

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Background: Diabetes is commonly associated with dyslipidemia, which is one of the major risk factors of coronary heart disease (CHD), the leading cause of mortality in patients with type 2 diabetic. It is thus desirable that an anti-diabetic drug must provide good glycaemic control and in addition cause correction of dyslipidaemia, at the same time being safe. Fenugreek, a traditional drug has been found to have beneficial effect on glycaemic control as well as lipid profile and may be thus useful in such patients. The study was thus planned to further explore the effect of fenugreek seed on glycaemic control and lipid profile by comparing it with a standard anti-diabetic drug glipizide. Methods: This 12 week, prospective, randomized, open-label, parallel group comparative study was conducted on 60 patients with type 2 diabetes. The patients were randomized to receive either glipizide 5 mg once daily (group A, n=20), fenugreek seed extract 500 mg twice a day (group B, n=20), or a combination of glipizide 2.5 mg and fenugreek seed extract 500 mg once daily (group C, n=20). The primary endpoint were the change in fasting blood glucose (FBG), glycated haemoglobin (HbA1c), and lipid profile from baseline after 12 weeks of treatment. Results: A statistically significant decline in mean FBG levels (group A -33.97%, p<0.001; versus group B -24.62%, p<0.001; versus group C -29.96%, p<0.001), and in HbA1c levels (group A -12.98 %, p<0.0001; group B -9.38%, p<0.0001; and group C -10.62%, p<0.0001) was seen in all three treatment groups. Total cholesterol (TC) reduced non-significantly in group A (-0.98%, p=0.1982), whereas in group B (-5.66%, p<0.001) and group C (-3.87%, p<0.001) it decreased significantly. Non-significant reduction in plasma triglycerides (TG) were seen in group A (-0.74%, p=0.0669), and significant reductions were seen in both group B (-17.23%, p<0.001) and group C (-11.34%, p<0.001). Low density lipoproteins cholesterol (LDL-C) showed nonsignificant reductions in group A (-0.74%, p=0.5482), and significant reductions in both group B (-4.15%, p<0.001) and group C (-2.68%, p=0.0463). Highdensity lipoproteins cholesterol (HDL-C) showed non-significant changes in all three groups (group A -0.60%, p =0.1529; group B 0.65%, p=0.2072; and group C 0.76%, p = 0.0543). The adverse drug reactions seen were mild in nature and none of the patients was withdrawn from the study because of serious adverse drug reactions. Conclusions: Monotherapy with fenugreek produced significant improvement in glycaemic control and dyslipidaemia. Glipizide monotherapy was more efficacious in controlling FBG and HbA1c levels than fenugreek monotherapy or in combination with fenugreek; glipizide monotherapy had no effect on lipid profile whereas fenugreek monotherapy was more efficacious in controlling dyslipidaemia than in combination with glipizide. Both drugs as monotherapy or in combination were well-tolerated by the patients.

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“…It is noteworthy that the decrement in the area under the plasma glucose concentration curve during the OGTT after administration of pioglitazone was decreased by 17% (P ϭ 0.01 vs. baseline; P Ͻ 0.01 vs. placebo). Thus, pioglitazone, unlike metformin (7) and sulfonylureas (22), significantly improved the postprandial glucose excursion. Consistent with this observation, the decrement in mean plasma glucose con- centration during the OGTT (68 Ϯ 14 mg/dl) was greater (P Ͻ 0.01) than the decrement in FPG concentration (50 Ϯ 12 mg/dl) after pioglitazone treatment.…”

Section: Regression Analysesmentioning

confidence: 99%

Improved Glycemic Control and Enhanced Insulin Sensitivity in Type 2 Diabetic Subjects Treated With Pioglitazone

et al. 2001

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OBJECTIVE -To elucidate the effects of pioglitazone treatment on glucose and lipid metabolism in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS -A total of 23 diabetic patients (age 30 -70 years, BMI Ͻ 36 kg/m2 ) who were being treated with a stable dose of sulfonylurea were randomly assigned to receive either placebo (n ϭ 11) or pioglitazone (45 mg/day) (n ϭ 12) for 16 weeks. Before and after 16 weeks of treatment, all subjects received a 75-g oral glucose tolerance test (OGTT); and hepatic and peripheral insulin sensitivity was measured with a two-step euglycemic insulin (40 and 160 mU ⅐ min Ϫ1 ⅐ m -2 ) clamp performed with 3-[ 3 H]glucose and indirect calorimetry. HbA 1c was measured monthly throughout the study period.RESULTS -After 16 weeks of pioglitazone treatment, the fasting plasma glucose (FPG; 184 Ϯ 15 to 135 Ϯ 11 mg/dl, P Ͻ 0.01), mean plasma glucose during OGTT (293 Ϯ 12 to 225 Ϯ 14 mg/dl, P Ͻ 0.01), and HbA 1c (8.9 Ϯ 0.3 to 7.2 Ϯ 0.5%, P Ͻ 0.01) decreased significantly without change in fasting or glucose-stimulated insulin/C-peptide concentrations. Fasting plasma free fatty acid (FFA; 647 Ϯ 39 to 478 Ϯ 49 Eq/l, P Ͻ 0.01) and mean plasma FFA during OGTT (485 Ϯ 30 to 347 Ϯ 33 Eq/l, P Ͻ 0.01) decreased significantly after pioglitazone treatment. Before and after pioglitazone treatment, basal endogenous glucose production (EGP) and FPG were strongly correlated (r ϭ 0.67, P Ͻ 0.01). EGP during the first insulin clamp step was significantly decreased after pioglitazone treatment (P Ͻ 0.05), whereas insulin-stimulated total and nonoxidative glucose disposal during the second insulin clamp was increased (P Ͻ 0.01). The change in FPG was related to the change in basal EGP, EGP during the first insulin clamp step, and total glucose disposal during the second insulin clamp step. The change in mean plasma glucose concentration during the OGTT was strongly related to the change in total body glucose disposal during the second insulin clamp step.CONCLUSIONS -These results suggest that pioglitazone therapy in type 2 diabetic patients decreases fasting and postprandial plasma glucose levels by improving hepatic and peripheral (muscle) tissue sensitivity to insulin. Diabetes Care 24:710 -719, 2001T ype 2 diabetes is characterized by defects in both insulin secretion and insulin sensitivity (1,2). The insulin resistance is established early in the natural history of type 2 diabetes (1-3), but with time there is a progressive failure of ␤-cell function (1,4,5). Based on the pathophysiology of type 2 diabetes, combination therapy with an insulin secretagogue and an insulin sensitizer provides a rational therapeutic approach to reduce blood glucose levels in poorly controlled type 2 diabetic patients (6). Such an approach has been used successfully with sulfonylureas and metformin (7).Recently, a new class of insulinsensitizing agents, the thiazolidinediones, was introduced for the treatment of type 2 diabetic patients (8). Troglitazone, the first thiazolidinedione introduced into the U.S. market, has been...

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Efficacy, Safety, and Dose-Response Characteristics of Glipizide Gastrointestinal Therapeutic System on Glycemic Control and Insulin Secretion in NIDDM: Results of two multicenter, randomized, placebo-controlled clinical trials

Cited by 127 publications

References 0 publications

Present status of sulfonylurea treatment for type 2 diabetes in Japan: Second report of a cross-sectional survey of 15,652 patients

Present status of sulfonylurea treatment for type 2 diabetes in Japan: Second report of a cross-sectional survey of 15,652 patients

Comparative evaluation of glipizide and fenugreek (Trigonella foenum-graecum) seeds as monotherapy and combination therapy on glycaemic control and lipid profile in patients with type 2 diabetes mellitus

Improved Glycemic Control and Enhanced Insulin Sensitivity in Type 2 Diabetic Subjects Treated With Pioglitazone

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