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Gestational diabetes mellitus (GDM) is a major public health concern because of rising rates and offspring consequences; yet, expert panels are in complete disagreement on how to diagnose and optimally treat GDM. This review underscores why there remains no diagnostic standard, no agreement on whether excess dietary carbohydrate or fat should be reduced, and whether oral hypoglycemic therapy is safe given the unknown offspring effects on hepatic, pancreatic, or fat development.
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Oral antidiabetic combination therapy is a proven means of establishing glycaemic control in the hyperglycaemic, Type 2 diabetic patient, but co-administering two oral antidiabetic agents separately may hinder compliance with therapy. A new single-tablet of glyburide/metformin combination therapy (Glucovance), Bristol-Myers Squibb, Inc.) has recently been developed, which addresses the primary defects of Type 2 diabetes: beta-cell dysfunction and insulin resistance. The glyburide/metformin tablet, taken with meals, is designed to optimise the absorption of glyburide and to address the postprandial glucose rise. Glyburide/metformin tablets are more effective in controlling fasting and postprandial glycaemia than its component monotherapies, at lower doses of metformin and glyburide compared with monotherapy because of the synergy between its glyburide and metformin components. Moreover, a double-blind study showed that glyburide/metformin tablets are more effective than a free combination of glyburide co-administered with metformin in controlling postprandial glucose. Retrospective analyses suggested that glyburide/metformin tablets control glycated haemoglobin (A1C) more effectively than a free combination of glyburide co-administered with metformin, at lower mean doses of glyburide and metformin. The incidence of side effects is lower than separate component therapy for any given A1C. Glyburide/metformin tablets are an effective option for optimising the control of blood glucose in Type 2 diabetic patients and appear to enhance adherence to therapy.
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At week 16, patients who received glyburide/metformin 2.5 mg/500 mg or 5.0 mg/500 mg tablets had greater reductions in FPG (all p<0.001) compared with glyburide or metformin monotherapy. Patients who took glyburide/ metformin 2.5 mg/500 mg tablet and glyburide/metformin 5.0 mg/500 mg tablet had significant decreases in HbA1c (both p<0.0125). Furthermore, treatment with glyburide/metformin 2.5 mg/500 mg resulted in significantly greater reduction in HbA1c compared to glyburide or metformin (-1.77%, p<0.001 and -1.34%, p=0.002), and treatment with glyburide/metformin 5.0 mg/500 mg resulted in significant lowering of HbA1c compared to glyburide or metformin alone (-1.73%, p<0.001 and -1.30%, p=0.005). Both the glyburide/metformin 2.5 mg/500 mg and glyburide/metformin 5.0 mg/500 mg combination therapy groups experienced fewer gastrointestinal adverse events than the metformin monotherapy group.
Using nationwide administrative Danish registries, we followed all individuals without prior stroke or myocardial infarction who initiated metformin and an IS from 1997 through 2009. Rate ratios (RR) of all-cause mortality, cardiovascular death, and a composite of myocardial infarction, stroke, or cardiovascular death were compared between user groups using time-dependent multivariable Poisson regression models. The most common combination, glimepiride+metformin, was used as reference.
After 24 weeks, therapy with glyburide/metformin plus rosiglitazone resulted in a greater reduction in HbA1C levels (-1.0%, P<0.001) compared with combination therapy that included placebo, and in a larger proportion of patients (42% vs. 14%) who attained levels <7%. The difference in fasting plasma glucose levels between groups was -48 mg/dL (P<0.001), favoring glyburide/metformin plus rosiglitazone. The adverse event profile in the rosiglitazone-treated group included mild-to-moderate edema (8%), hypoglycemia (22%), and weight gain of 3 kg. No patient experienced hypoglycemia requiring third-party assistance.
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Single-tablet metformin-glibenclamide combination treatment is more effective than metformin or glibenclamide monotherapy, and is well tolerated in patients with hyperglycaemia inadequately controlled by diet and exercise or antidiabetic monotherapy, irrespective of their severity of hyperglycaemia at baseline, age or weight.
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The present investigation was based on the latest quality by design principles, using the design of experiments technique. The aim was to attain an immediate release formulation of metformin hydrochloride and glibenclamide and to optimize the delivery of these two different antidiabetic agents within a single-tablet combination.
We conclude that after a 7.7-year follow-up, monotherapy with either glyburide or metformin in diabetic patients with CAD yielded a similar outcome and was associated with a modest increase in mortality. However, time-related mortality was markedly increased when a combined glyburide/metformin treatment was used.
Glucovance, recently launched by Merck-Lipha (Glucovance 500 mg/2.5 mg and Glucovance 500 mg/5 mg), is a fixed combined therapy of a sulphonylurea (glibenclamide 2.5 or 5 mg) and a biguanide (metformin 500 mg), indicated for the treatment of type 2 diabetes in adult patients. The only current official indication in Belgium is the substitution of a dual therapy with metformin and glibenclamide in patients with a stable and adequate metabolic control. The fixed combination aims at simplifying patient's treatment in order to improve compliance despite polymedication. In addition, it allows targeting synergistically the two main abnormalities of type 2 diabetes, i.e. the insulin secretory defect and the insulin resistance.
Adherence was measured by medication possession ratio; the proportion of days on which a patient had medication available.
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The diabetic groups presented similar clinical characteristics upon recruitment. Crude mortality rate after a 7.7-year follow-up was lower in nondiabetics (14 vs. 31.6%, p<0.001). Among diabetics, 720 patients died: 260 on diet (mortality 26.3%), 324 on glyburide (34%), 25 on metformin alone (31.6%), and 111 patients (43.9%) on combined treatment (p<0.000001). Time-related mortality was almost equal for patients on metformin and on combined therapy over an intermediate follow-up period of 4 years (survival rates 0.80 and 0.79, respectively). The group on combined treatment presented the worst prognosis over the long-term follow-up, with a time-related survival rate of 0.59 after 7 years, versus 0.68 and 0.70 for glyburide and metformin, respectively. After adjustment to variables for prognosis, the use of the combined treatment was associated with an increased hazard ratio (HR) for all-cause mortality of 1.53 (95% confidence interval [CI] 1.20-1.96), whereas glyburide and metformin alone yielded HR 1.22 (95% CI 1.02-1.45) and HR 1.26 (95% CI 0.81-1.96), respectively.
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Glyburide/metformin combination therapy reduced hemoglobin A levels from 0.087 to 0.083 (P < 0.06). Significant reductions were seen in those patients with initial levels higher than 0.08 (0.094 to 0.087; P < 0.01). No significant reductions were seen in those patients with initial levels lower than 0.08.
Final HbA(1c) values were lower for repaglinide/metformin treatment than for nateglinide/metformin (7.1 vs. 7.5%). Repaglinide/metformin therapy showed significantly greater mean reductions of HbA(1c) (-1.28 vs. -0.67%; P < 0.001) and of fasting plasma glucose (FPG) (-39 vs. -21 mg/dl; P = 0.002). Self-monitoring of blood glucose profiles were significantly lower for repaglinide/metformin before breakfast, before lunch, and at 2:00 A.M. Changes in the area under the curve of postprandial glucose, insulin, or glucagon peaks after a test meal were not significantly different for the two treatment groups during this study. Median final doses were 5.0 mg/day for repaglinide and 360 mg/day for nateglinide. Safety assessments were comparable for the two regimens.
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An open-label, parallel-group, randomized, multicenter trial was conducted to compare efficacy and safety of repaglinide versus nateglinide, when used in a combination regimen with metformin for treatment of type 2 diabetes.
Longitudinal data from a large claims database were used to assess adherence from January 1, 2000, to December 31, 2001. Propensity scoring methods were used to mitigate concerns related to non-random assignment of patients to treatments.
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The combination treatments were more effective than either monotherapy irrespective of baseline HbA1C, age or BMI in each trial. Antihyperglycaemic effects were greater in patients with HbA1C > or = 8% at baseline, especially with the combinations. The majority of hypoglycaemic symptoms with glibenclamide-containing treatments occurred in patients with HbA1C < 8% at baseline. Neither age nor BMI had a marked effect on the efficacy of the combination treatments, and there was no increase in hypoglycaemic symptoms in older patients.
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In this 16-week, double-blind, multicentre, parallel-group trial, 411 patients were randomized to receive metformin 500 mg, glibenclamide 5 mg, metformin-glibenclamide 500 mg/2.5 mg or metformin-glibenclamide 500 mg/5 mg, titrated with the intention to achieve fasting plasma glucose (FPG) < or = 7 mmol/l.
Both glyburide/metformin 2.5 mg/500 mg and glyburide/metformin 5.0 mg/500 mg combination therapy were efficacious and well tolerated in the treatment of Chinese patients with type 2 diabetes mellitus.
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Due to the poor flow properties of metformin hydrochloride, in order to attain the dose uniformity, a wet granulation based manufacturing process was used. The prepared tablets were evaluated for the release of metformin hydrochloride and glibenclamide using validated HPLC methods. The similarity factor was calculated, taking into consideration as reference profile the mean in vitro dissolution data of Glucovance. The formulation process was undertaken using a reproducible DoE generated model, attained by the variation of each of the formulation factors on two levels, followed by the filling of the data resulted from the analytical testing of the tablets.
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Decreases in glycated haemoglobin (HbA1c) and FPG were greater (P < 0.05) for metformin-glibenclamide 500 mg/2.5 mg (-1.20% and -2.62 mmol/l) and 500 mg/5 mg (-0.91% and -2.34 mmol/l), compared with metformin (-0.19% and -0.57 mmol/l) or glibenclamide (-0.33% and -0.73 mmol/l). HbA1c < 7% was achieved by 75% and 64% of patients receiving metformin-glibenclamide 500 mg/2.5 mg and 500 mg/5 mg, respectively, compared with 42% for glibenclamide and 38% for metformin (P = 0.001). These benefits were achieved at lower mean doses of metformin or glibenclamide with metformin-glibenclamide 500 mg/2.5 mg and 500 mg/5 mg (1225 mg/6.1 mg and 1170 mg/11.7 mg) than with glibenclamide (13.4 mg) or metformin (1660 mg). Treatment-related serious adverse events occurred in two patients receiving glibenclamide. Plasma lipid profiles were unaffected and mean changes in body weight were < or = 1.0 kg.
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It is important to manage blood glucose intensively in patients with type 2 diabetes mellitus in order to reduce the risk of long-term complications. Oral combination therapy that addresses insulin resistance and beta-cell dysfunction is a proven means of improving glycaemic control when monotherapy becomes insufficiently effective. Metformin/glibenclamide (glyburide) combination tablets were developed to provide a means of applying this strategy while minimising polypharmacy. This review examines the tolerability profile of this treatment from four double-blind, randomised clinical trials in a total of 2342 type 2 diabetic patients with hyperglycaemia despite treatment with diet and exercise, a sulphonylurea or metformin. Treatment with combination tablets was associated with markedly superior blood glucose control, at lower doses of metformin and glibenclamide, compared with monotherapies. The incidence of symptoms of hypoglycaemia varied between dosages and trials, though the incidence of severe or biochemically confirmed hypoglycaemia or withdrawals from clinical trials for this reason was consistently low and comparable with glibenclamide alone. No patient required third-party assistance for hypoglycaemia. Significantly fewer diet-failed patients receiving low-dose combination tablets reported gastrointestinal adverse effects compared with metformin alone, with a comparable incidence between metformin and combination tablets in post-monotherapy studies. The incidence of other adverse events, including serious adverse events, was similar for combination tablets and monotherapies. The lower doses of metformin and glibenclamide with the combination tablet approach, and the design of the combination tablets themselves, may underlie the beneficial tolerability profile of this treatment.
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The inverse correlation between the complexity of a drug regimen and medication adherence is well established. Fixed-dose combination (FDC) therapies are hypothesized to enhance compliance by decreasing the number of required pills.
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To study glycemic control before and after initiation of secondary antihyperglycemic therapy to better understand the pace and patterns of therapeutic failure and clinical responses to failure.
Oral anti-diabetic combinations that address insulin resistance and beta-cell dysfunction (e.g. metformin and glibenclamide) represent a rational therapeutic option for patients uncontrolled on monotherapy. A 52-week, open-label extension to a double-blind study evaluated metformin-glibenclamide combination tablets (Glucovance) in 477 patients with hyperglycaemia despite sulphonylurea therapy. Reductions in HbA1C were maintained, with a mean reduction of -1.7% after 52 weeks, compared with the baseline value for the double-blind trial. Eighty-five patients receiving 4 x 500 mg/2.5 mg tablets daily displayed a marked improvement in HbA1c following up-titration to a regimen of 2 x 500 mg/2.5 mg + 3 x 500 mg/5 mg tablets. Lipid profiles improved significantly. The combination tablets were well tolerated: 11.1% of patients reported hypoglycaemic symptoms (all either mild or moderate severity). No patient withdrew or required pharmacologic intervention for hypoglycaemia. Metformin-glibenclamide combination tablets are an effective and well-tolerated therapeutic option for intensifying oral anti-diabetic therapy.
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The level of HbA1c that seemed to trigger glucose-lowering action was 9.0% or higher, not 8.0% as recommended by the ADA. A substantial hyperglycemic peak preceded change in therapy even in this relatively tightly controlled population with type 2 diabetes mellitus. Earlier therapeutic changes, but not more frequent testing, would prevent the glycemic excursions we observed. Low mean HbA1c levels in populations do not necessarily indicate that loss of glycemic control is being rapidly addressed for most patients. More research is needed to estimate the impact of these peaks on current well-being and future complications.
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The last HbA1c level before metformin use averaged 9.4%. Metabolic decompensation accelerated over time. Patients typically spent numerous months at and had several measurements of HbA1c >8.0% before a final glycemic spike to >9.0%. Persons experiencing more gradual failure accumulated greater glycemic burdens before changing therapy.