Aim: The aim of this trial was to obtain further data on the efficacy and safety of benfluorex as an add-on therapy in type 2 diabetic patients insufficiently controlled by sulfonylurea monotherapy who had a limitation for the use of metformin during a 4-month extension period following a 4-month double-blind trial.
Methods: Patients who completed the 18-week double-blind period entered the 16-week extension period. Patients in the benfluorex group during the double-blind period continued benfluorex 450 mg/day (B-B group), whilst patients in the placebo group switched to benfluorex 450 mg/day (P-B group).
Objective: The aim of this study was to demonstrate the superiority of benfluorex over placebo as an add-on therapy in type 2 diabetic patients in whom diabetes is insufficiently controlled by sulfonylurea monotherapy and who have a limitation for the use of metformin.
Research Design And Methods: Type 2 diabetic patients with HbA(1c) (A1C) (7-10%) who were receiving the maximum tolerated sulfonylurea dose and had a contraindication to or poor tolerance of metformin were randomly assigned (double blind) to receive benfluorex 450 mg/day (n = 165) or placebo (n = 160) for 18 weeks. The main efficacy criterion was A1C, analyzed as the change from baseline to the end of treatment using ANCOVA with baseline and country as covariates.
Twenty-three diabetic patients -- 16 men and seven women (mean age: 50.7 +/- 17.4 years; mean duration of diabetes: 13.
View Article and Find Full Text PDFThe aim of the present study was to investigate the effect of both gender and age on insulin secretion, peripheral insulin effectiveness and insulin-receptor binding. Eighty healthy volunteers, 40 females of mean age 38.47 +/- 11.
View Article and Find Full Text PDFObjectives: The aim of the present study was to investigate insulin secretion, insulin-receptor binding and peripheral insulin sensitivity in subjects with different degrees of obesity.
Methods: 36 obese subjects with normal glucose tolerance and different degrees of obesity and 40 healthy normal-weight subjects participated in the study. Peripheral insulin sensitivity was measured by using the euglycaemic hyperinsulinaemic clamp technique, and insulin-receptor binding-on circulating mononuclear blood cells.
Obesity is considered a chronic disease requiring treatment. The effect of sibutramine combined with hypocaloric diet and exercise on body weight, body fat mass, lipids, glycemic control, insulin secretion and insulin resistance was evaluated in a randomized, controlled, open-label study. A total of 44 obese type 2 diabetic patients (aged 45.
View Article and Find Full Text PDFSevere hypoglycemia (SH) can be a significant problem for patients around the world with Type 1 Diabetes Mellitus (T1DM). To avoid SH, patients need to better manage, and reduce the occurrence of, preceding mild hypoglycemia. Hypoglycemia Anticipation, Awareness and Treatment Training (HAATT), developed in the United States specifically to address such issues, was evaluated at short- and long-term follow-up in a medically, economically and culturally different setting; Bulgaria.
View Article and Find Full Text PDFAim: to evaluate the effect of alpha-lipoic acid in autonomic diabetic neuropathy in a controlled, randomized, open-label study.
Material And Methods: 46 patients with type 1 diabetes and different forms of autonomic neuropathy, of mean age 38.1 +/- 12.
Rom J Intern Med
December 2004
The aim of the present study was to evaluate the effect of metformin on body weight, body fat mass, waist circumference, lipid parameters, insulin secretion and insulin resistance in obese subjects with normal glucose tolerance. 26 subjects (16 females and 10 males), mean age 37.3+/-9.
View Article and Find Full Text PDFThe aim of the present randomized, controlled study was to evaluate the effect of a 5-day teaching program for diabetic patients on their quality of life 1 and 2 years afterwards. Three hundred and nineteen insulin-treated patients, of mean age 38.2+/-14.
View Article and Find Full Text PDFMenopause is associated with two main risk factors for the development of type 2 diabetes mellitus--impaired beta-cell insulin secretion and insulin resistance. Physiologically estrogens improve carbohydrate metabolism, but this is not the case with different progestogens. The aim of the present study was to evaluate the effect of Cyproterone acetate (a progestogen with antiandrogenic activity) on insulin secretion, peripheral insulin sensitivity, lipid parameters and parameters of oxidative stress.
View Article and Find Full Text PDFDiabetes Res Clin Pract
January 2003
The effect of repaglinide on insulin secretion and oxidative stress was evaluated in type 2 diabetic patients in a randomized, controlled, open-label trial. Forty-six patients were treated for 2 months with repaglinide, added to either diet (n=21) or metformin (n=25). A control group of 29 patients, matched for age, weight and glycaemic control, on either diet (n=13) or metformin (n=16) was also followed-up.
View Article and Find Full Text PDFThe aim of the present study was to evaluate the effect of metformin in very obese subjects with acanthosis nigricans. Five patients (two obese children, mean age 14.4 +/- 0.
View Article and Find Full Text PDFThe aim of the present study was to evaluate the effect of three different combinations of hormone replacement therapy (HRT) on insulin secretion, peripheral insulin sensitivity, serum lipid levels and parameters of oxidative stress. Seven type II diabetic women of mean age 55.4 +/- 4.
View Article and Find Full Text PDFExp Clin Endocrinol Diabetes
January 2002
The study was designed to evaluate the pattern of insulin secretion and the presence of anti-GAD65 antibodies as beta-cell autoimmune marker in subjects with impaired glucose tolerance (IGT) and their impact on the further development of glucose intolerance. 29 subjects with IGT, of mean BMI 24.7 +/- 2.
View Article and Find Full Text PDF201 insulin-treated diabetic patients were followed upto 6 months and 1 year after a 5-day structured teaching program. There was a significant increase in overall quality of life (score 51+/-5.7 after 1 year versus 41+/-6.
View Article and Find Full Text PDFThe outcome data from the United Kingdom Prospective Diabetes Study (UKPDS) showed that intensive drug treatment of diabetes mellitus-type 2 and the tight control of glycaemia and blood pressure are associated with lower incidence of chronic diabetic complications and mortality. The economical analysis showed out that money invested in the intensive drug treatment of diabetes and arterial hypertension resulted in less expenses for the treatment of diabetic complications. These data are the reason to suggest an algorythm for the treatment of diabetes mellitus type 2.
View Article and Find Full Text PDFMethods Find Exp Clin Pharmacol
March 1996
In a previous paper we demonstrated a link between growth hormone releasing hormone (GHRH) and prostaglandin E2 (PGE2) in their action on growth hormone (GH) in normal subjects. However, in diabetes mellitus various disturbances of GH and PGE2 secretion have been reported. In the present study the response of GH, PGE2 and insulin to GHRH (1 microgram/kg b.
View Article and Find Full Text PDFObjective: To study the tolerability and efficacy of acipimox on hyperlipidemia and diabetes compensation in patients with NIDDM under conditions of a routine clinical practice.
Research Design And Methods: We recruited 121 patients (60 men and 61 women) from 10 participating clinical centers. They were randomly divided into two groups and treated for 3 mo either with acipimox (250 mg three times a day) or placebo, using an open study design.
Thirty-five non-insulin-dependent diabetic subjects were divided into two groups, according to therapeutical approach. The first group consisted of 17 diabetics receiving sulfonylureas and maintaining a satisfactory metabolic control. The second group included 18 patients who were transferred from sulfonylureas to insulin treatment, i.
View Article and Find Full Text PDFThe urine excretion of the catecholamines adrenalin, noradrenalin and dopamine as well as the serum levels of cortisol and STH were determined with the aim to establish objective criteria for a "latent" hypoglycaemia in diabetics. The altogether 45 insulin-requiring diabetics had no hypoglycaemia (n = 28) and the decrease of blood sugar, respectively, occurred during the daytime (n = 6) or at night (n = 11). From the results no significance for the catecholamines as parameters of a hypoglycaemia that happened long ago can be derived.
View Article and Find Full Text PDFProbl Endokrinol (Mosk)
May 1991
A total of 121 inpatients with insulin and noninsulin dependent diabetes mellitus were investigated. The patients with noninsulin dependent diabetes mellitus were divided into 2 groups with relation to the presence or absence of secondary resistance to sulfonyl urea derivatives. Changes in the plasma and lipoprotein concentration of cholesterol (ChS) and triglycerides (TG) were analyzed.
View Article and Find Full Text PDFThe insulin receptor binding ability was studied in 26 persons with above normal body mass (15 women and 11 men), mean age 44.15 +/- 10.1 years without family history of diabetes mellitus.
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