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Microsoft word - diamicron mr factsheet_final.doc

Diamicron MR®
– Factsheet –
What is Diamicron MR?
• Diamicron MR is a globally well known oral antidiabetic agent containing a modified-
release version of the active ingredient gliclazide. • Diamicron MR belongs to a class of oral hypoglycaemic agents known as the sulfonylureas, and is used to help control blood glucose levels in patients with type 2 How does it work?
• Diamicron MR is the first oral antidiabetic agent to employ an innovative formulation based
on a hydrophilic matrix. This matrix releases Diamicron’s short-acting active sulfonylurea ingredient (gliclazide) over a 24-hour period with only one intake at breakfast, between 1 and 4 tablets (30mg to 120mg). Because the release profile of the active glucose-lowering drug is perfectly matched to the normal rise and fall in blood glucose levels which occur in type 2 diabetes patients over the course of a day, Diamicron MR is able to achieve an effective 24-hour glycaemic control with a remarkable safety profile.1,2,3,6 • The unique formulation of Diamicron MR also allows for once-daily dosing of the drug. This is an important factor in encouraging patients to be compliant with long-term treatment and thus ensuring that tight glycaemic control is maintained. • Once released, the gliclazide active ingredient reduces blood glucose levels by stimulating insulin secretion from the β-cells in the pancreas.4 It does this by selectively stimulating specialised receptors on the pancreas’s insulin-producing cells, evoking an effective secretagogue effect which is synergistic with glucose’s stimulation of insulin secretion.5 • In type 2 diabetics, gliclazide restores the first peak of insulin secretion in response to glucose and increases the second phase of insulin secretion.4 A significant increase in insulin response is also seen in response to stimulation induced by a meal or glucose.4 What is the evidence for Diamicron MR in type 2 diabetes?
Diamicron MR’s effectiveness as a treatment for type 2 diabetes is supported by a vast body of
evidence from clinical trials carried out over both the long and short term. Daily efficacy • The release of active ingredient from Diamicron MR has been shown to match the natural changes in blood glucose levels which occur in type 2 diabetics over the course of a day.1,2 This means that Diamicron MR is able to provide good glycaemic control around the clock.3 Short-term efficacy • In the GUIDE (GLUcose control in type 2 diabetes: Diamicron MR versus glimEpiride) trial, Diamicron MR was shown to achieve tight glycaemic control from as early as 9 weeks of • When compared to another sulfonylurea, glibenclamide, Diamicron MR also demonstrated superior efficacy in controlling blood glucose. After 16 weeks of treatment, patients on Diamicron MR had a significantly lower HbA1c compared to those on glibenclamide.7 • Used as monotherapy in newly diagnosed type 2 diabetic patients, Diamicron MR also demonstrated powerful glycaemic control.6 Patients’ HbA1c levels were reduced by 1.3% Long-term efficacy • In a large, randomized, double-blind, international study of over 500 patients Diamicron MR proved effective over a 2-year treatment period.8 Patients receiving Diamicron MR experienced significant reductions in their HbA1c levels after both 1 and 2 years of treatment.8 • Another long-term trial looked at secondary failure rates* among type 2 diabetics treated with either Diamicron MR, glibenclamide or glipizide over a 5-year period.9 Significantly greater therapeutic success was achieved with Diamicron MR where only 7% of patients failed, compared to secondary failure rates of over 17% on glibenclamide and more than 25% on glipizide.9 Based on the results of this study, it was concluded that Diamicron MR may be a better choice than other sulfonylureas for long-term therapy.9 • Results of a retrospective study have also shown that Diamicron MR is able to provide sustained efficacy without insulin for up to 14.5 years.10 Compared to patients treated with glibenclamide, the period until start of insulin treatment was significantly longer in the Diamicron group, with Diamicron MR buying an extra 6.5 years before the need to initiate insulin.10 Efficacy in combination • For many diabetic patients, combination therapy will be a necessary step to keep glucose levels under control. In clinical trials, Diamicron has been shown to be effective in combination with both metformin and insulin.6,11 • As Diamicron MR is also able to restore endogenous insulin secretion, patients taking Diamicron MR and insulin in combination may have up to 40% less insulin requirements, with no sacrifice in glycaemic control.12 • Diamicron MR can reduce the progression of atherosclerosis in type 2 diabetics, slowing the rate at which major arteries ‘fur up’.13 Diamicron MR also acts to slow the rate of oxidation of LDL cholesterol, which is an important step on the pathway to atherosclerosis • Diamicron MR acts to decrease the mass of the left ventricle – one of the vital pumping chambers of the heart – suggesting a direct improvement in cardiovascular morbidity.15 • Patients treated with Diamicron MR show an increased survival of ~2-fold compared to • Newer sulfonylureas such as Diamicron MR have been proven to significantly reduce the risk of heart attack (myocardial infarction) in type 2 diabetics.16 • Diamicron MR, unlike older sulfonylureas, is able to reduce the death of essential insulin- producing cells in the pancreas.17,18 This protective effect allows these vital beta cel s to function better and survive longer.17,18 Is Diamicron MR safe?
• Diamicron MR has a favourable efficacy-safety ratio as proven by a large pool of clinical
data from randomized, double-blind trials.19,20 • One particular safety benefit of Diamicron MR is its low risk of hypoglycaemia (low blood glucose levels).6 Once it has exerted its therapeutic effect, gliclazide detaches itself easily from the beta cell receptors in the pancreas.21 This reduces the risk of Diamicron MR producing an ongoing and unnecessary glucose lowering effect, which can lead to the • Treatment with Diamicron MR is associated with 50% fewer hypoglycaemic episodes compared to glimepiride and some studies have also shown that Diamicron MR has a significantly lower incidence of hypoglycaemia than glibenclamide, even in elderly patients who are at higher risk of hypoglycaemia.6,20,22,23 • Because of this favourable glycaemic safety profile, Diamicron MR is suitable for use in both elderly and renally impaired diabetic patients. • Diamicron MR is also weight neutral, with studies showing no increase in BMI during up to Why was Diamicron MR chosen for ADVANCE?
• In testament to its important position in the arena of diabetes management, Diamicron MR
was chosen as the glucose-lowering agent of choice in the intensive treatment arm of the largest prospective study ever carried out in type II diabetes: ADVANCE (Action in
Diabetes and Vascular disease – PreterAx and DiamicroN MR Controlled Evaluation). This
important study was set up to evaluate the effects of strict blood glucose and blood pressure control on micro- and macrovascular outcomes in type 2 diabetic patients with • Diamicron MR was chosen for the ADVANCE study for a number of key reasons: It is proven to provide tight and additive glycaemic control.6 It is remarkably safe even at higher doses – up to four tablets at breakfast.6 Its innovative modified-release formulation ensures effective 24-hour glucose control Its cardiovascular protection thanks to unique antioxidant properties.13-17 • These important advantages arise as a result of Diamicron MR’s unique antioxidant properties, which act independently of its effect on blood glucose levels.24 By scavenging harmful free radicals and so reducing the oxidative stress which is a key part of diabetes, Diamicron is able to both improve beta cell survival and offer direct cardiovascular References
1 Francillard M, Frey N, Paraire M et al. Pharmacokinetics of Diamicron modified release (MR) in 1007 type 2 diabetic patients. J Nutr Health Aging 2001; 5(special issue): 14. 2 Reaven GM, Hollenbeck C, Jeng C-Y et al. Measurement of plasma glucose, free fatty acid, lactate and insulin for 24 h in patients with NIDDM. Diabetes 1998; 37: 1020-1024. 3 Guillausseau PJ, Greb W. 24-hour glycemic profile in type 2 diabetic patients treated with gliclazide modified release once daily. Diabetes Metab 2001; 27: 133-137. 4 Diamicron MR Summary of Product Characteristics (SpC). Updated February 2007. 5 Gregorio F, Ambrosi F, Cristallini S et al. Therapeutical concentrations of tolbutamide, glibenclamide, gliclazide and gliquidone at different glucose levels: in vitro effects on pancreatic and beta-cell function. Diabetes Res Clin Prac 1992; 18: 197-206. 6 Schernthaner G, Grimaldi A, Di Mario U et al. GUIDE study: double-blind comparison of once-daily gliclazide MR and glimepiride in type 2 diabetic patients. Eur J Clin Invest 2004; 34: 535-542. 7 Kardas P. The DIACOM study (effect of Dosing frequency of oral Antidiabetic agents on the COMpliance and biochemical control of type 2 diabetes). Diab Obes Metab 2005; 7: 722-728. 8 Drouin P, Standl E for the Diamicron MR study group. Gliclazide modified release: results of a 2-year study in patients with type 2 diabetes. Diabetes Obes Metab 2004; 6: 414-421. 9 Harrower ADB, Wong C. Comparison of secondary failure rate between three second-generation sulfonylureas. Diabetes Res 1990; 13: 19-21. 10 Satoh J, Takahashi K, Takizawa Y et al. Comparison of period until insulin treatment between diabetic patients treated with gliclazide and glibenclamide. Diabet Res Clin Prac 2005; 70: 291-297. 11 Furlong NJ, Hulme SA, O’Brien SV et al. Comparison of repaglinide vs. gliclazide in combination with bedtime NPH insulin in patients with type 2 diabetes inadequately controlled with oral hypoglycemic agents. Diabet Med 2003; 20: 935-941. 12 Quatraro A, Consoli G, Ceriello A et al. Combined insulin and sulfonylurea therapy in non-insulin-dependent diabetics with secondary failure to oral drugs: a 1 year follow-up. Diabetes Metab 1986; 12: 315-318. 13 Katakami N, Yamasaki Y, Hayaishi-Okano R et al. Metformin or gliclazide, rather than glibenclamide, attenuate progression of carotid intima-media thickness in subjects with type 2 diabetes. Diabetologia 2004; 47: 1906-1914. 14 O’Brien RC, Luo M, Balazs N et al. In vitro and in vivo antioxidant properties of gliclazide. J Diabetes Complications 2000; 14: 201-206. 15 Pan NH, Lee TM, Lin MS et al. Association of gliclazide and left ventricular mass in type 2 diabetic patients. Diabetes Res Clin Pract 2006; 74: 121-128. 16 Johnsen SP, Monster TBM, Ilsen ML et al. Risk and short term prognosis of myocardial infarction among users of antidiabetic drugs. Am J Ther 2006; 13: 134-140. 17 Del Guerra S, Grupillo M, Masinin M et al. Gliclazide protects human islet bet-cells from apoptosis induced by intermittent high glucose. Diabetes Metab Res Rev 2007; 23: 234-238. 18 Del Guerra S, Grupillo M, Lupi R et al. Functional and molecular effects of gliclazide and glibenclamide on isolated islets cultured at high glucose concentrations. 43rd Annual Meeting, Amsterdam 18-21 September 2007. EASD Abstract Volume 2007; S361 (O875) 19 Drouin P and the Diamicron MR study group. Diamicron MR is effective and well tolerated once daily in type 2 diabetes: a double-blind, randomized, multinational study. J Diabetes Complications 2000; 14: 185-191. 20 Tessier D, Dawson K, Tetrault JP et al. Glibenclamide vs gliclazide in type 2 diabetes of the elderly. Diabet Met 1994; 11: 974-980. 21 Ashcroft FM, Gribble FM. Tissue-specific effect of sulfonylureas: lessons from studies of cloned KATP channels. J Diabetes Complications 2000; 14: 192-196. 22 Jennings AM, Wilson RM, Ward JD. Symptomatic hypoglycemia in NIDDM patients treated with oral hypoglycemic agents. Diabetes Care 1989; 12: 203-208. 23 Van Staa T, Abenhaim L, Monette J. Rates of hypoglycemia in users of sulfonylureas. J Clin Epidemiol 1997; 50: 735-741. 24 Gribble FM, Reimann F. Sulphonylurea action revisited: the post-cloning era. Diabetologia 2003; 46: 875-891.




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