PRECOSE SUMMARY
PRECOSE®
(acarbose tablets)
PRECOSE® (acarbose tablets) is an oral alpha-glucosidase inhibitor for use in the management of type 2 diabetes mellitus.
PRECOSE®, as monotherapy, is indicated as an adjunct to diet to lower blood glucose in patients with type 2 diabetes mellitus whose hyperglycemia cannot be managed on diet alone. PRECOSE® may also be used in combination with a sulfonylurea when diet plus either PRECOSE® or a sulfonylurea do not result in adequate glycemic control. Also, PRECOSE® may be used in combination with insulin or metformin. The effect of PRECOSE® to enhance glycemic control is additive to that of sulfonylureas, insulin, or metformin when used in combination, presumably because its mechanism of action is different.
In initiating treatment for type 2 diabetes mellitus, diet should be emphasized as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling blood glucose and symptoms of hyperglycemia. The importance of regular physical activity when appropriate should also be stressed. If this treatment program fails to result in adequate glycemic control, the use of PRECOSE® should be considered. The use of PRECOSE® must be viewed by both the physician and patient as a treatment in addition to diet, and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint.
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NEWS HIGHLIGHTS
Published Studies Related to Precose (Acarbose)
Effects of acarbose treatment on markers of insulin sensitivity and systemic inflammation. [2011.06]
BACKGROUND: This study assessed the effect of postprandial glucose reduction by acarbose on insulin sensitivity and biomarkers of systemic inflammation... CONCLUSIONS: Reduction of the glycemic load by acarbose decreased fasting levels of proinsulin but had no effect on adiponectin and whole-body insulin sensitivity as well as biomarkers reflecting inflammation. The preventive effects of acarbose on type 2 diabetes mellitus and cardiovascular risk need further investigation and cannot be explained by changes of insulin resistance and inflammatory biomarkers.
Acarbose actions on insulin resistance and inflammatory parameters during an oral fat load. [2011.01.25]
The aim of this study was to evaluate the effects of acarbose on inflammatory biomarkers and insulin resistance in diabetic patients before and after a standardized oral fat load (OFL). Ninety six patients were assigned to take acarbose 50mg three times a day and 92 to take placebo; after the first month acarbose was titrated to 100mg three times a day...
A prospective, parallel group, open-labeled, comparative, multi-centric, active controlled study to evaluate the safety, tolerability and benefits of fixed dose combination of acarbose and metformin versus metformin alone in type 2 diabetes. [2010.11]
OBJECTIVE: The present study was a prospective, parallel group, open-labeled, comparative, multicentric, active controlled study to evaluate the safety, tolerability and benefits of fixed dose combination of acarbose and metformin versus metformin alone in type 2 diabetic patients... CONCLUSIONS: Fixed dose combination of acarbose and metformin was well tolerated and it was superior to metformin monotherapy in controlling FBG, PPBG and HbA(1C) levels in Type 2 Diabetes Mellitus patients.
Impact of acarbose on carotid intima-media thickness in patients with newly diagnosed impaired glucose tolerance or mild type 2 diabetes mellitus: A one-year, prospective, randomized, open-label, parallel-group study in Japanese adults with established coronary artery disease. [2010.08]
OBJECTIVE: This study examined the effect of acarbose therapy on carotid intima-media thickness (IMT) in patients with established coronary artery disease (CAD) who had been newly diagnosed with impaired glucose tolerance (IGT) or mild type 2 diabetes mellitus (T2DM)... CONCLUSION: In this small, open-label study in patients with established CAD who were newly diagnosed with IGT or mild T2DM, 12 months of treatment with acarbose was associated with a beneficial effect in terms of preventing the progression of carotid IMT compared with control, although it was not associated with a significant decrease in IMT from baseline. UMIN (University Hospital Medical Information Network) Clinical Trials Registry identifier: UMIN000000544. Copyright (c) 2010 Excerpta Medica Inc. All rights reserved.
Postprandial endothelial dysfunction in subjects with new-onset type 2 diabetes: an acarbose and nateglinide comparative study. [2010.03.24]
BACKGROUND: Postprandial hyperglycemia is believed to affect vascular endothelial function. The aim of our study was to compare the effects of acarbose and nateglinide on postprandial endothelial dysfunction... CONCLUSIONS: Our results suggest that acarbose improves postprandial endothelial function by improvement of postprandial hyperglycemia, independent of postprandial hyperinsulinemia. Acarbose may thus have more beneficial effects on postprandial endothelial function in patients with type 2 diabetes than nateglinide.
Clinical Trials Related to Precose (Acarbose)
A Phase III Randomized, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Acarmet (Metformin HCl 500 mg Plus Acarbose 50 mg Tablets) Versus Acarbose Alone in Subjects With Type 2 Diabetes Mellitus [Recruiting]
Type 2 diabetes mellitus is a chronic metabolic disorder which is caused by both insulin
secretion deficiency and insulin action defect. In this type of subjects, fasting
hyperglycemia is the result of the elevated rate of basal hepatic glucose production, and it
is coexisting with hyperinsulinemia. After a meal, the impaired control of hepatic glucose
production by insulin and decreased insulin-mediated glucose uptake by muscle contributed
nearly equally to postprandial hyperglycemia(Scheen, 1997). Type 2 diabetic subjects
experience significant morbidity and mortality from microvascular (retinopathy, nephropathy,
and neuropathy) and macrovascular (cardiovascular disease, stroke, and peripheral vascular
disease) complications. The appropriate treatment and good glycemic control of diabetes is
therefore important and necessary (Vaag, 2006). Evidences suggest that combination therapy
using oral antidiabetic agents with different mechanisms of action may be more effective in
achieving and maintaining target blood glucose level (Turner et al., 2005).There are five
classes of oral antihyperglycemic agents (sulfonylureas, biguanides, α- ucosidase
inhibitors, thiazolidinediones and meglitinides) currently available to improve glycemic
control in subjects with type 2 diabetes, each of which works through a different mechanism
of action. Metformin, a biguanide which has insulin-sensitizing properties, can be used
alone or in combination with other classes of agents. Metformin is the currently the
first-choice treatment in subjects with diagnosed type 2 diabetic subjects and obesity,
characterized by insulin-resistance. Metformin also provides reduction of body weight and
ameliorates lipid abnormalities and is thought to be related to a reduction in hepatic
gluconeogenesis (Hundal & Inzucchi, 2003).Acarbose, the α-glucosidase inhibitor, is approved
for the treatment of type 2 diabetes, and first approved for prediabetes treatment (Chiasson
et al., 1994; Breuer, 2003; Chiasson et al., 2002). The drug was launched worldwide as a
type 2 diabetes monotherapy and combination therapy in 1990 which has proven efficacious as
first-line therapy (Coniff et al., 1995) and in combination with sulfonylureas or insulin
(Kelley et al., 1998). Acarbose and metformin are both associated with beneficial effects on
hyperglycemia, hyperinsulinemia, body weight, and, in some studies,triglyceride levels
(Krentz et al., 1994). Because these factors are part of a cluster of risk factors for
cardiovascular disease, combining the two drugs may be useful. In long-term clinical
studies, acarbose has shown a favorable safety profile (Hasche et al., 1999).In combination
with metformin, acarbose has been shown to improve long-term glycemic control (Rosenstock et
al., 1998; Halimi et al., 2000). This study was conducted as a further vestigation into the
efficacy and safety of concurrent use of acarbose and metformin in type 2 diabetes mellitus
subjects. Lotus Pharmaceutical Co., Ltd. intends to initiate Phase III program to investigate
assess the efficacy and safety of metformin in combination with acarbose for type 2 diabetes
mellitus subjects considered inadequately blood glucose control. Since combination tablet of
acarbose and metformin has not yet been approved by the Taiwan DOH, this study is conducted
to evaluate the efficacy and safety of combination tablet of acarbose and metformin in the
treatment of type 2 diabetes mellitus subjects in Taiwan. Acarbose is chosen as an
active-comparator.
Study to Evaluate the Efficacy of Acarbose,Metformin,Sitagliptin Combination Treatment in DM Patients [Not yet recruiting]
Primary objective To evaluate the efficacy of Acarbose added on top of Metformin and
Sitagliptin that were combinedly administered to subjects with type-II diabetes, along with
placebos.
Secondary objectives
1. To compare a Metformin-Sitagliptin combination and a Sitagliptin-Acarbose combination
in efficacy
2. To evaluate the 6-month efficacy of Acarbose added on top of the Metformin-Sitagliptin
combination
GlucoFriend-evaluation the Effectiveness of Glucobay When Combined With a Basal Insulin [Recruiting]
To evaluate the effectiveness of Glucobay when combined with a basal insulin under
daily-life treatment conditions in a large sample of Korean patients.
GLucobay M OBservation Study for Efficacy and Safety in Treatment of Type-2 Diabetes Patients [Recruiting]
An observational and multicenter study to assess the effectiveness and safety of Glucobay®-
M under daily life treatment of type-2 diabetes patients. The study objectives are to
investigate the effectiveness and safety of Glucobay® - M on blood glucose and patients body - weight. Glucobay®- M is taken 1-3 times daily. All patients with type 2 diabetes mellitus,
where investigator feels that addition of Glucobay®-M would be beneficial to patients will
be included in non- interventional study. The routine investigation suggested by the
attending physician will be done in diabetic patients. No additional investigation will be
done for the study purpose. The uncontrolled diabetic patient on existing treatment and
prescribed Glucobay®-M will be included in study after taking the informed consent. The
patient will be asked to attend 2 follow up visit each after 6 weeks. All patients receiving
at least one tablet will be included in the safety analysis. The study is planned to be
carried out in 10000 patients from 320-350 trial sites in India.
Special Drug Use Investigation of Glucobay OD [Recruiting]
Reports of Suspected Precose (Acarbose) Side Effects
Blood Glucose Increased (2),
Adverse Reaction (2),
Traumatic Fracture (1),
Fall (1),
Loss of Consciousness (1),
Malaise (1),
Thinking Abnormal (1),
Diabetes Mellitus Inadequate Control (1),
Decreased Appetite (1),
Drug Hypersensitivity (1), more >>
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Page last updated: 2011-12-09
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