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At least 829 records · Page 46Linked to original sources

PubMed1986

Effects of two new alpha-glucosidase inhibitors on glycemic control in patients with insulin-dependent diabetes mellitus.

BAYo1248 and BAYm1099 are two new alpha-glucosidase inhibitors. Postprandial glucose tolerance was significantly improved and postprandial insulin requirements were significantly reduced as compared to placebo after breakfast and lunch when 20 mg BAYo1248 were administered prior to breakfast and after breakfast, lunch and dinner when 50 mg BAYm1099 were given prior to all three main meals. Postprandial breath H2 concentrations were mildly increased when these alpha-glucosidase inhibitors were given and no patient complained of any adverse effects (such as flatulence, abdominal pain or diarrhea). BAYo1248 and BAYm1099 might be useful adjuncts to insulin in the treatment of patients with insulin-dependent diabetes mellitus.

1-Deoxynojirimycin↗

PubMed1979

The effects of the alpha-glucosidase inhibitor BAY g 5421 (Acarbose) on postprandial blood glucose, serum insulin, and triglyceride levels: dose-time-response relationships in man.

In a double-blind quadruple cross-over study the effect of a new alpha-glucosidase inhibitor (BAY g 5421) on postprandial blood glucose, serum insulin, and serum triglyceride increases was tested in 24 male healthy volunteers. They received before a standardized breakfast 50, 100, or 200 mg of BAY g 5421 or a placebo per os. The dose-time-response relationships were calculated and the drug tolerance was assessed. There was a statistically significant inhibition of the postprandial increases of the blood glucose, serum insulin, and triglyceride values. Further analysis showed no dose-dependent effect of the drug on the blood glucose values, whereas the serum insulin and triglyceride values were affected in a dose-dependent fashion. The maximal inhibitory effect on the serum insulin levels occurred 69 min after breakfast and on the serum triglyceride levels 104 min after breakfast. One hundred and 200 mg of BAY g 5421 were equally inhibitory-effective on the serum insulin levels, whereas the highest dose used was markedly more effective on serum triglyceride values than lower doses. Based on these results, a dosage of 100--200 mg of BAY g 5421/meal is recommended for clinical trials in metabolic diseases.

Administration, Oral↗

PubMed1996

A radiopaque marker technique for measuring gastrointestinal transit in subjects with an ileostomy.

We aimed to develop a simple, clinically useful technique for measuring gut transit time in patients with an ileostomy, in order to distinguish easily when patients have fast or slow transit. Seventeen healthy subjects (mean age, 55 years; range, 43-71 years; nine males) who had had a proctocolectomy for ulcerative colitis more than 1 year previously and without small intestinal resection were studied. Subjects were studied on 4 days after an overnight fast, two studies with and two without breakfast. A standard diet was used on all days. Twenty radiopaque markers were given at the start of each study day. Ileostomy effluent was collected over 24 hr and x-rayed to determine the number of retained markers. Studies with breakfast demonstrated greater intrasubject reproducibility. The mean transit time for passage of 50% of markers was 16.6 hr with, and 14.8 hr without, breakfast (p < 0.02). From the data obtained we suggest that the optimum time for taking a single abdominal radiograph in a patient with suspected fast transit is 6 hr after ingestion of markers, while the optimum time for a patient with suspected slow transit is 24 hr.

Adult↗

PubMed1999

Dietary zinc intake of a group of long-stay mentally handicapped women: some bioavailability considerations.

Dietary factors affecting zinc bioavailability were evaluated according to their relative distribution in the individual daily meals making up the basic diet of 17 institutionalized, mentally handicapped adult women. Mean intake values of zinc, phytate, nonstarch polysaccharides (NSP), calcium, protein, and energy were calculated from a dietary survey of 7 consecutive days, which also served to obtain values for the two zinc bioavailability predictor formulas, phytate/Zn millimolar ratio and [Ca][phytate]/[Zn][energy] ratio. Mean daily zinc intake was 8.5 +/- 1.8 mg, with noon and evening meals accounting for the highest contribution to this value (45% and 35%, respectively), whereas breakfast meals' contribution was 16%. The mean protein intake was 55 +/- 13 g, with noon and evening meals being the major contributors to total daily intake (42% and 38%, respectively). Breakfast meals accounted for 77% of daily phytate intake, giving a respective phytate/Zn millimolar ratio of 20.4 +/- 7.6 and a [Ca][phytate]/[Zn][energy] ratio of 336 +/- 127 mmol/Mcal. Values for both ratios based on noon and evening meals were negligible in comparison. The mean daily NSP intake was 9.8 +/- 4.2 g, with 53% of total daily intake supplied from breakfast meals, whereas noon and evening meals accounted for 30% and 14%, respectively. The results, while suggesting that zinc bioavailability is unlikely to be adversely affected, indicated that dietary fiber intake levels are probably inadequate, particularly in view of the nonambulant condition and low physical activity prevalent in such individuals, who may, as a consequence, be susceptible to health disorders associated with impaired bowel function and constipation.

Adult↗

PubMed1981

The effects of equal caloric amounts of xylitol, sucrose and starch on insulin requirements and blood glucose levels in insulin-dependent diabetics.

Xylitol has been suggested as a potentially useful sweetener in the diabetic diet. In 14 insulin-dependent diabetics a standard diabetic diet regimen was compared with diets in which starch was isocalorically exchanged in the breakfast meal by either 30 g xylitol or 30 g sucrose. Insulin requirement and blood glucose were measured using a glucose-controlled insulin infusion system. The results following breakfast with xylitol were similar to those after starch breakfasts. Sucrose, in contrast, induced a greater post-prandial rise in blood glucose levels despite counter-regulation by the glucose-controlled insulin infusion system. Insulin requirement after sucrose significantly exceeded (p less than 0.01) that after xylitol or starch during the first 60 min and 2 h respectively. No short-term side effects of xylitol were found.

Adult↗

PubMed2006

Oesophageal dysmotility, delayed gastric emptying and autonomic neuropathy correlate to disturbed glucose homeostasis.

AIMS/HYPOTHESIS: Among diabetic patients, glucose homeostasis may be affected by abnormal gastrointestinal motility and autonomic neuropathy. This study analysed whether oesophageal dysmotility, delayed gastric emptying or autonomic neuropathy affect glucose homeostasis. MATERIALS AND METHODS: Oesophageal manometry and gastric emptying scintigraphy were performed in 20 diabetic patients. Heart-rate variation during deep breathing (expiration/inspiration [E/I] ratio) and continuous subcutaneous glucose concentrations for a period of 72 h were also monitored in the same patients. RESULTS: Oesophageal dysmotility was found in eight of 14 patients. Eleven of 20 patients had delayed gastric emptying (abnormal gastric emptying half-time [T (50)]) and nine of 18 had an abnormal E/I ratio. Complaints of abdominal fullness were predictive of delayed gastric emptying. A low peristaltic speed of the oesophagus was associated with impaired T (50) (r ( s )=-0.67; p=0.02). One hour after breakfast, subcutaneous glucose levels decreased in patients with delayed gastric emptying but continued to rise in those with normal emptying. Consequently, the median glucose level 2.5 h after breakfast was lower in the former (9.1 [4.2-12.5] vs 14.3 [11.2-17.7] mmol/l; p<0.05). Glucose fluctuations during the 72 h were significantly higher in patients with an abnormal E/I ratio than in those with a normal E/I ratio (coefficient of variation: 41 [46-49] vs 28 [27-34]%; p=0.008). CONCLUSIONS/INTERPRETATION: Abdominal fullness predicted delayed gastric emptying that was associated with diminished glucose uptake after breakfast. Low oesophageal peristaltic speed was associated with slow gastric emptying whereas parasympathetic neuropathy was associated with increased glucose variations.

Autonomic Nervous System Diseases↗

PubMed1998

Conditioned flavour preference negatively reinforced by caffeine in human volunteers.

This study examined whether 100 mg caffeine could reinforce preference for the flavour of a novel drink in moderate caffeine users, both after overnight caffeine abstinence and 2 h after receiving 100 mg caffeine, using a two-stage between-groups procedure with 36 volunteers. In the first stage, liking for a test drink (fruit tea) was assessed at breakfast following overnight caffeine abstinence, with half the subjects receiving caffeine. Liking for the tea increased significantly over four trials for subjects receiving caffeine, and decreased significantly in those without caffeine. These effects were greatest in subjects who rated the drink as highly novel. In stage two, subjects evaluated a second drink (fruit-juice) 2 h after receiving the tea, and again half the subjects received caffeine Those subjects who received caffeine in stage two but not stage one showed a significant increase in liking for the fruit-juice over the 4 test days, whereas subjects who did not receive caffeine at either stage showed a progressive decrease in liking for this drink. In contrast, no significant change in liking for the fruit-juice was seen at stage two for subjects who had received caffeine in stage one, regardless of the presence or absence of caffeine at stage two. Caffeine at breakfast increased ratings of energetic and lively, and energetic ratings also increased following caffeine in the fruit-juice in subjects who had not had caffeine at breakfast. Overall, these data are consistent with a negative reinforcement model of caffeine reinforcement, and demonstrate further the utility of the conditioned flavour preference method for evaluating reinforcing effects of drugs in humans.

Adult↗

PubMed2002

The effects of food on the pharmacokinetic profile of oral vinorelbine.

The effects of food on the pharmacokinetics and safety profile of a soft-gel capsule formulation of vinorelbine (Navelbine Oral) were evaluated in fed and fasted patients with solid tumours or lymphomas. A group of 18 patients (12 planned) were entered into a multicentre phase I pharmacokinetic study following a crossover design with a 1-week wash-out period. Patients received the first dose of 80 mg/m(2) oral vinorelbine either after fasting or after ingestion of a standard continental breakfast. The second dose of 80 mg/m(2) was administered 1 week later in the alternate feeding condition to the first dose. Of the 18 patients, 13 were eligible for pharmacokinetic evaluation. The mean time to maximum concentration (T(max)) was shorter in fasted patients (1.63+/-0.98 h in blood, 1.67+/-0.96 h in plasma) than in fed patients (2.48+/-1.40 h in blood, 2.56+/-1.65 h in plasma) but these differences are not likely to modify the safety and/or efficacy of oral vinorelbine. Values for C(max) and AUC were similar in fed and fasted patients and no significant differences were observed. The safety profile of oral vinorelbine observed in this limited number of patients appears to be comparable to that usually reported for vinorelbine, the main toxicity being neutropenia. Only one episode of febrile neutropenia was reported. The main nonhaematological toxicities encountered were gastrointestinal, consisting of nausea, vomiting, diarrhoea and constipation. A tendency for a lower incidence of vomiting was suggested when oral vinorelbine was administered after a standard breakfast. Based on this study, the administration of oral vinorelbine to fasted patients is not mandatory since administration after a standard breakfast does not lead to differences in body exposure to the drug. As the comfort of patients may be improved when the treatment is administered after a light meal, this procedure can be recommended in clinical practice.

Administration, Oral↗

PubMed1993

Food pattern, diet quality, and related characteristics of schoolchildren in New York State.

OBJECTIVES: To examine the food patterns and diet quality of elementary schoolchildren in New York State (outside of New York City) and to determine sociodemographic characteristics correlated with diet quality. DESIGN: A nonquantitative 24-hour recall administered to students and a brief questionnaire completed by parents. SAMPLE: 1,797 second and fifth graders (51% of those asked) in 51 randomly selected schools (46% of those asked) in New York State outside of New York City. STATISTICAL ANALYSES: Multiple regression analyses, chi 2, and t tests. RESULTS: On the day they were surveyed, 40% of students did not eat vegetables, except for potatoes or tomato sauce; 20% did not eat fruit; 36% ate at least four different types of snack foods, and 16% of fifth graders did not eat breakfast. Children who ate a school lunch ate significantly more dairy foods and fruits and vegetables, and fewer snack-foods than those who brought lunch from home. Fifth graders ate significantly more snack foods and were more likely to skip breakfast than second graders; boys had lower food-group pattern scores than girls; children of lower socioeconomic status had less diverse diets but ate less snack foods than children of higher socioeconomic status; children with single parents were more likely to skip breakfast and to eat fewer vegetables than those with two parents; and children with mothers employed outside the home had less diverse diets than those with mothers at home. APPLICATIONS/CONCLUSIONS: The findings indicate that nutrition interventions are clearly needed for this age group and that targeted messages should be based on sociodemographic characteristics.

Child↗

PubMed1989

Carbohydrate metabolism in the course of intrahepatic cholestasis in pregnancy.

Glucose metabolism was evaluated in pregnant women with clinically and biochemically demonstrated intrahepatic cholestasis. Laboratory investigations included measurements of serum glucose concentrations on fasting and 2 hours after breakfast, the glucose tolerance test (100 gm oral glucose load), and 24-hour glycemia profile. All patients were admitted to the II Department of Obstetrics and Gynecology, Institute of Obstetrics and Gynecology of the Medical School in Warsaw, Poland. None of the patients exhibited manifest diabetes mellitus or had any clinical history suggestive of previous diabetes. The serum samples collected 2 hours after breakfast demonstrated higher glucose concentrations in women with intrahepatic cholestasis when compared with healthy control subjects. The glucose tolerance tests demonstrated consistently higher concentrations of glucose in blood serum samples after loading in the study group. The 24-hour glycemia profile showed greater glucose concentrations in serum samples collected 2 hours after breakfast and after supper. These results suggest that in the course of cholestasis in pregnancy, visible changes occur in the carbohydrate metabolism of the pregnant woman.

Blood Glucose↗

PubMed1981

Ablation of the area postrema causes exaggerated consumption of preferred foods in the rat.

The area postrema (AP) is a hindbrain circumventricular organ (CVO) with apparent chemoreceptive function. The AP has demonstrated neural and vascular connections with the nucleus of the solitary tract (SOL), a structure which receives the primary visceral afferents from the oral cavity and gastrointestinal tract. The anatomical structure and connections of the AP suggests a potential role for this CVO in the control of feeding behavior. We have found that rats with surgically produced AP lesions consumed the same amounts of pelleted food ad libitum as control rats. Lesioned and control rats also consumed equal amounts of lab chow after 21 h food deprivation. However, when presented with a preferred food (instant breakfast or cookies), AP-lesioned rats consumed at least double the amount consumed by control rats. It is possible that AP lesions impair sensitivity to satiety cues. However, lesion rats did decrease their instant breakfast intake in response to cholecystokinin injections or gastric preloads. Furthermore, overingestion by AP-lesioned rats occurred only in response to preferred (highly palatable) foods and not in response to lab chow. Lesioned rats rejected quinine-adulterated instant breakfast at the same adulterant concentration as controls. Therefore, the lesioned rats do not suffer from ageusia or from enhanced responsiveness to bitter taste. Rather, the selective overeating by AP-lesioned rats may reflect an enhanced behavioral response to the sensory qualities of normally preferred foods. The close association of the AP with the SOL provides a neuroanatomical avenue by which a putative AP-chemoreceptor could alter the quality or intensity of information arriving via the taste afferents. Such tuning of gustatory mechanisms could be an important component of ingestive control.

Animals↗

PubMed1986

Comparison study of sustained-release theophylline products: Slo-bid capsules versus Theo-Dur tablets in 20 children and young adults with asthma.

Because there are few published studies on capsulized sustained-release theophylline (SRT) products in children, we compared Slo-bid capsules to Theo-Dur tablets in a group of school age children and young adults with asthma in an 8-week randomized crossover study design with patients maintaining daily symptom diary cards and peak expiratory flow rates. Theophylline levels were obtained at 8 hours after the morning dose on day 7, 14, and 28 of each study period. Data were analyzed by one-way analysis of variance, regression equation, and Student's t test. Both products were demonstrated to have grossly similar absorption characteristics and efficacy at 12-hour intervals in the age group studied. Average daily dose requirement was 717 mg/day. Considerable week-to-week intrapatient variation in 8-hour theophylline levels was noted in both products, implying that precise dose adjustments cannot be made from a given level. Our literature review reveals the need for more data to support the current widespread practice of dosing children less than 8 years of age at 12-hour intervals. A retrospective review of ingestion before and after breakfast revealed no variation between the seven patients ingesting SRT before breakfast compared to 13 patients routinely ingesting SRT after a typical childhood breakfast.

Adolescent↗

PubMed1991

Variation of endogenous insulin secretion in association with treatment status: assessment by serum C-peptide and modified urinary C-peptide.

The variation of endogenous insulin secretion in association with fasting plasma glucose (FPG) level and the modality of treatment was assessed using serum C-peptide levels before and after breakfast and the corrected value of 24-h urinary C-peptide (24 h-UCP) in inpatients with non-insulin-dependent diabetes mellitus. The corrected value calculated as 24 h-UCP/(urinary C-peptide to creatinine clearance (CCP/CCR) ratio in the fasting state x 10) was correlated with the sum of day-long serum C-peptide levels (r = 0.93) more closely than the measured value of 24 h-UCP (r = 0.79) in 9 patients. In 52 patients treated with diet alone, 38 with sulfonylurea and 28 with insulin, fasting serum C-peptide level did not vary with FPG level, and the increment of serum C-peptide level after breakfast and the corrected value of 24 h-UCP decreased with the rise in FPG level in each treatment. These indexes were the lowest in insulin treatment among the patients with similar FPG levels. In conclusion, 24 h-UCP was demonstrated to be able to reflect day-long endogenous insulin secretion more faithfully after the correction with the CCP/CCR ratio. It was estimated that the insulin response to breakfast and day-long insulin secretion decreased with the rise in FPG level, but basal insulin secretion was maintained over a wide range of FPG levels in each treatment. Endogenous insulin secretion seemed to be somewhat suppressed or rested by exogenous insulin in insulin-treated patients.

Biomarkers↗

PubMed2026

Mealtime satisfaction in public nursing homes: Associations with sensory, foodservice, and dining-room environment factors.

Satisfaction with meals is commonly used to assess how meals are experienced in nursing homes (NH), although limited evidence compares breakfast, lunch, and dinner within a unified analytical framework. This study examined the sensory and contextual factors associated with satisfaction across meals in public NH. A cross-sectional observational study was conducted using structured interviews with 290 residents aged ≥60 years (median 85 years; Q1-Q3: 81-88; 63.1% women) from 19 facilities in Galicia, Spain. Overall satisfaction and 12 factors related to sensory attributes of the food, foodservice characteristics, and dining-room environment were assessed using a 5-point Likert scale. Descriptive analyses used medians and quartiles, and group comparisons were performed using nonparametric tests. Three multivariable linear regression models, one per meal, were estimated including all factors simultaneously. In adjusted models, the largest standardized coefficients were observed for taste (lunch: β = 0.366; P < 0.001), food temperature at serving (dinner: β = 0.319; P < 0.001), and menu variety (breakfast: β = 0.301; P < 0.001). Taste, food temperature at serving, menu variety, and meal schedule showed statistically significant coefficients in all models. Overall satisfaction was lower at dinner (29.0% ≥ 4) than at breakfast (34.8%) and lunch (34.5%) (P = 0.003). Selected dining-room environment factors showed significant coefficients in meal-specific models. Mealtime satisfaction was mainly associated with sensory and contextual factors related to how meals are perceived. Lower satisfaction at dinner suggests this mealtime as a relevant context for understanding variations in meal perception in NH residents.

Humans↗

PubMed2005

The influence of product and oral characteristics on swallowing.

The urge to swallow food could be triggered by a threshold level in both food particle size and lubrication of the food bolus. Thus, both oral physiology and product characteristics may influence the swallowing threshold. We quantified the swallowing threshold in a group of 266 healthy adult subjects (age 42 +/- 12 years) by counting the number of chewing cycles needed to prepare food for swallowing. The influence of oral physiology on the swallowing threshold was determined by measuring salivary flow rate, maximum bite force and masticatory performance. We used about 10 cm(3) of bread, toast, melba toast, breakfast cake, peanuts and cheese to determine the influence on the swallowing threshold of various food characteristics, e.g. hardness, moisture and fat. Furthermore, we tested the effect of buttering the bread, toast, melba toast and breakfast cake on the swallowing threshold. Salivary flow rates were significantly and negatively correlated with the number of chewing cycles of melba toast and breakfast cake. Hence, subjects with more saliva needed less chewing cycles for these dry products. Maximum bite force and masticatory performance had an influence on the swallowing threshold for the hard products only (carrot and peanut). Although significant, the correlation coefficients were less than 0.28. Thus, the oral physiology parameters explained less than 10% of the variance in the swallowing threshold. We found significantly different numbers of chewing cycles for the various foods, ranging from 17 for cake to 63 for carrot. Hard and dry products needed more chewing cycles until swallowing. Buttering the food significantly reduced the number of chewing cycles needed before swallowing. This was especially true for the dry products cake, melba toast and toast. Hard and dry products require more chewing cycles and longer time in mouth until swallowing for sufficient breakdown to take place and for enough saliva to be added to form a coherent bolus safe for swallowing. In spite of this, more saliva, higher maximum bite force and better masticatory performance were only weakly correlated with a smaller number of chewing cycles. Butter enhanced lubrication and bolus formation of dry products, thus reducing the number of chewing cycles until swallowing. In conclusion, product characteristics and to a lesser extent oral physiology significantly affect swallowing threshold.

Adult↗

PubMed2005

Diurnal and acute patterns of postprandial apolipoprotein B-48 in VLDL, IDL, and LDL from normolipidemic humans.

Smaller size particles of intestinal origin may be more relevant to atherosclerosis than larger particles because of easier transendothelial transport. We examined the diurnal pattern in response to low-fat high-carbohydrate meals and the effect of a single high-fat milkshake on apoB-48 in very light Sf degrees >400, light Sf degrees 60-400, and dense Sf degrees 20-60 VLDL, IDL, and LDL in 24 subjects (12 in each study). After the high-fat meal, apoB-48 concentrations peaked at 3 h for very light VLDL, 4 h for light VLDL, and 5 h for dense VLDL and IDL, suggesting a delipidation cascade. The diurnal pattern was characterized by a sharp increase in light and dense VLDL apoB-48 after breakfast, reaching the highest concentration 4-8h after breakfast. Less response was observed after lunch, dinner or snack, despite 75% of energy supplied by these meals. The proportion of apoB-48 in LDL in the fasting state ranged between 48 and 54%. LDL apoB-48 concentration decreased by 35% after the high-fat meal, and slowly recovered to near fasting concentrations after 10-12 h. In contrast, in the diurnal study, LDL apoB-48 concentration steady increased peaking 13 h after breakfast, followed by a sharp decrease. In sum, most intestinally synthesized apoB lipoproteins circulate in LDL, and are likely formed in the late postprandial period from larger VLDL-size particles. Although small apoB-48 lipoproteins may be atherogenic remnant particles, their very low concentration may diminish their clinical significance.

Aged↗

PubMed2004

Combined therapy with insulin lispro Mix 75/25 plus metformin or insulin glargine plus metformin: a 16-week, randomized, open-label, crossover study in patients with type 2 diabetes beginning insulin therapy.

OBJECTIVE: This study aimed to assess glycemic response to a mixture of 75% insulin lispro protamine suspension and 25% insulin lispro (Mix 75/25) BID plus metformin versus insulin glargine QD plus metformin in patients with type 2 diabetes mellitus (DM). METHODS: Adults new to insulin therapy were enrolled in a multicenter, randomized, prospective, open-label, crossover study with 16 weeks on each treatment. Variables included glycosylated hemoglobin (HbA(1c)), hypoglycemia rate, fasting blood glucose (FBG), 2-hour postprandial blood glucose (ppBG), and rise in blood glucose after meals. RESULTS: One hundred five patients (mean age, 55 years) were randomized. There was no difference in baseline mean values for either treatment sequence group for body mass index, duration of DM, or HbA(1c). Ninety-five patients completed the study and 67 were included in the efficacy analysis. Mix 75/25 was associated with lower mean (SD) HbA(1c) at end point (7.4% [1.1%] vs 7.8% [1.1%]; P = 0.002). More patients using Mix 75/25 achieved target HbA(1c) < or =7.0% (42% [30/71] vs 18% [13/71]; P < 0.001). With Mix 75/25, the mean (SD) 2-hour ppBG was similar after lunch but lower after breakfast (156.4 [43.6] vs 171.1 [44.9] mg/dL; P = 0.012) and dinner (164.8 [42.5] mg/dL vs 193.8 [51.0] mg/dL; P < 0.001), although FBG was higher (139.3 [36.6] mg/dL vs 123.9 [34.9] mg/dL; P < 0.001). Rise in ppBG was lower with Mix 75/25 after breakfast (16.9 [47.0] mg/dL vs 47.4 [34.8] mg/dL; P < 0.001) and dinner (14.2 [44.1] mg/dL vs 45.9 [41.3] mg/dL; P < 0.001). Gain in mean (SD) body weight was greater with Mix 75/25 than insulin glargine (2.3 [4.0] kg vs 1.6 [4.0] kg; P = 0.006). For all randomized patients, mean (SD) hypoglycemia rates were lower with insulin glargine (0.68 [1.38] vs 0.39 [1.24] episodes/patient per 30 days; P = 0.041), although nocturnal hypoglycemia was similar. CONCLUSION: In this study population, Mix 75/25 plus metformin was associated with lower HbA(1c) than insulin glargine plus metformin, smaller rise in ppBG after breakfast and dinner, and higher proportion of patients achieving HbA(1c) < or =7.0%, with a slight increase in overall (but not nocturnal) hypoglycemia.

Adult↗

PubMed2005

Efficacy and safety of biphasic insulin aspart 30 combined with pioglitazone in type 2 diabetes poorly controlled on glibenclamide (glyburide) monotherapy or combination therapy: an 18-week, randomized, open-label study.

BACKGROUND: Few large randomized controlled trials have assessed the value of adding insulin to an oral antidiabetic drug regimen. OBJECTIVE: This trial compared the efficacy and safety of biphasic insulin aspart 30/70 (BIAsp 30) plus pioglitazone (n = 93), glibenclamide (glyburide) plus pioglitazone (n = 91), or BIAsp 30 monotherapy (n = 97). METHODS: This 18-week, multinational, multicenter, randomized, open-label, parallel-group trial involved 281 patients with type 2 diabetes (60% male; mean age, 56 years; mean body mass index, 29.5 kg/m2) with inadequate glycemic control (mean glycosylated hemoglobin [HbA(1c)], 9.5%; range, 7.4%-14.7%) on glibenclamide monotherapy or combination therapy. The primary objective was to compare end-of-trial HbA(1c) among the 3 treatment groups. Fasting and mean 7- and 8-point blood glucose profiles, blood lipid levels, plasminogen activator inhibitor levels, adverse events, and hypoglycemia frequency were also compared. Patients using BIAsp 30 (alone or with pioglitazone) were injected twice daily (immediately before breakfast and dinner). Pioglitazone (30 mg/d) and glibenclamide (5-15 mg/d) were taken orally once daily with or immediately after breakfast. RESULTS: At the end of the trial, HbA(1c) was significantly lower for the BIAsp 30 plus pioglitazone group than for the glibenclamide plus pioglitazone group (mean [SD], -0.64% [0.23%]; P = 0.005) and the BIAsp 30 monotherapy group (-0.60% [0.22%]; P = 0.008). Mean (SD) fasting blood glucose (before breakfast) was significantly lower for BIAsp 30 plus pioglitazone than for glibenclamide plus pioglitazone (153 [45] mg/dL vs 169 [65] mg/dL, respectively; P = 0.012). Each time point on the 8-point blood glucose profile was lower for BIAsp 30 plus pioglitazone than for glibenclamide plus pioglitazone (P < 0.001 to P < 0.05). No major hypoglycemic episodes were reported, and the absolute rate of hypoglycemic events was low (<1 event/patient-week) in the BIAsp-only group. Edema was reported in < or =9% of patients in each treatment group, but no occurrence was classified as serious. Weight gain (mean, 4.0 kg) was more common in the BIAsp plus pioglitazone group (8%); however, this was consistent with improved glycemic control and is similar to that reported in other pioglitazone trials. CONCLUSIONS: BIAsp 30 plus pioglitazone provided an efficacious and well-tolerated treatment alternative to glibenclamide plus pioglitazone or BIAsp 30 alone in this population of patients who previously were not well controlled on glibenclamide monotherapy or combination therapy.

Blood Glucose↗