Diamicron MR

The Power To Control Glycemia Back To Basic
Complications
Diabetic Retinopathy
Leading cause of blindness in adults
Stroke
2- to 4-fold increase in cardiovascular mortality and stroke
Cardiovascular Disease
8/10 individuals with diabetes die from CV events
Diabetic Neuropathy
Leading cause of non-traumatic lower extremity amputations
Diabetic Nephropathy
Leading cause of end-stage renal disease
85% -95% Type2 diabetes
333 million 350

Global prevalence of diabetes) 300 250
150 million
200
150 100 50 0 1985 2000 2025
30 million
Innovative formulation
First hydrophilic matrix-based OAD
HYDROPHILIC MATRIX
high-viscosity Hypromellose low-viscosity Hypromellose
GRANULES
GLICLAZIDE 30 MG
Unique pharmacodynamic properties
Reversible receptor binding:

Lower rate of hypoglycemia Weight neutrality
Diamicron MR acts only when needed
Benefits of Diamicron MRs innovative formulation
1. Once-daily regimen Excellent compliance no missing doses better efficacy (Irrespective of the total daily dose) 2. Release Profile matches to circadian hyperglycemic profile of type2 diabetics 24h efficacy + no high plasma peak (less risk of hypoglycemia)
Matching Gliclazide release with glycemic circadian variation
Plasmatic concentration (mcg/ml)
2 1 0 8 300 12 14 18 20 24 8h
Blood glucose level mg/dl
250 200 150 100 50 8 Meal 14 Meal 18 20 Meal 24 4 8
Efficient
Practical
Protection
Evidence that others Dont have
The largest morbidity-mortality trial ever performed in type 2 diabetes
11 140 patients
215 clinical centers 20 countries
Primary end point combined micro- and Macrovascular events

micro: new/worsening nephropathy or diabetic eye disease macro: nonfatal stroke, nonfatal MI or death from any CV cause
Diamicron MR in ADVANCE
Inclusion criteria
Type 2 diabetes mellitus Age 55 years or older Additional CV risk factor - Age 65 years - History of major macrovascular disease - History of major microvascular disease - First diagnosis of diabetes >10 years prior to entry - Other major risk factor Hypertensive or normotensive
Study DESIGN
Blood glucose-lowering arm
Intensive glycemic control
Diamicron MR All other OADs (except for SUs) Insulin Home glucose monitoring, more frequent follow-up, dietician review
HbA1c target 6.5%
Standard glycemic control
all OADs (except for gliclazide) insulin standard care
Local targets
Main results
Powerful EFFICACY
Efficacy
10.0 9.5 9.0 Mean HbA1c (%) 8.5
P<0.0001
Standard glycemic control Intensive glycemic control (Diamicron MR)
Mean HbA1c at final visit
8.0
7.5 7.0 6.5 6.0 5.5 5.0 0 1 2 3 Follow-up (years) 4 5
7.3% 6.5%
8/10 < 7%
Superior glycemic control
Whatever the severity of the disease
Superior glycemic control
Whatever the patient profile
Superior HbA1c reduction
Whatever the Duration of Diabetes
Peace of mind
Practicality
Remarkable safety
8X
2X
The lowest ever risk of severe hypoglycemia

1.ADVANCE Group. N Engl J Med 2008; 358:2560-72 / 2.ACCORD Study Group. N Engl J Med. 2008;358:2545-2559 /
Remarkable safety Guide Study
Strict weight neutrality
Strict weight-neutrality over 5 years
1.ADVANCE Group. N Engl J Med 2008; 358:2560-72 /
Weight neutrality
Strict weight neutrality with Diamicron MR

1.ADVANCE Group. N Engl J Med 2008; 358:2560-72 / 3.VADT Group. N Engl Med.2009;360:129-139
Protection
Protection
1.ADVANCE Group. N Engl J Med 2008; 358:2560-72 /
Unique cardiovascular risk reduction
Protect your patients from cardiovascular death
Focus on nephropathy
Albuminuria is a strong predictor of all-cause mortality, particularly from cardiovascular disease Incidence of renal failure is 6/1000 person year: 1/3 death 2/3 dialysis 50% will die within 3 years 20% of diabetic patients will die from renal disease Diabetes is the leading cause of ESRD: 50% patients receive renal replacement therapy
registry. Nephrol. Dial. Transplant. 1991;6(Sup1):5-35.
Major microvascular events
Number (%) of patients with event

Intensive (n=5571) Standard (n=5569) Favors Favors Relative risk Intensive Standard reduction (95% CI)
Microvascular
526 (9.4%) 605(10.9%)

349 (6.3%) 292 (5.2%) 0.5 1.0 Hazard ratio
14% (3 to 23) *
5% (-10 to 18) 21% (7 to 34)** 2.0
*2P=0.014
**2P=0.006
New or worsening retinopathy 332 (6.0%) New or worsening nephropathy 230 (4.1%)
Diamicron MR protects in particular the kidneys
Renal events
Number (%) of patients with event

Intensive (n=5571) Microalbuminuria Macroalbuminuria Standard (n=5569) Favors Favors Intensive Standard Relative risk reduction (95% CI) 9% (2 to 15)* 30% (15 to 43)** 1.0 Hazard ratio 2.0
1318 (23.7%) 1434 (25.7%) 162 (2.9%) 231 (4.1%) 0.5
*2P=0.018 **2P<0.001
Albuminuria is a well-recognized marker of renal disease and is predictive of increased CV risk
Kidney Protection
Bring patients Kidney Back to normal
Unique pharmacodynamic properties
Unique free radical scavenger ring

Reduces oxidative stress1
Nephropathy is linked to Oxidative Stress

Slowing down of atherosclerosis progression2 Protective action on kidneys
1. Del Guerra S, et al. Diabetes Metab Res Rev. 2007;23:234-238. 2.Katakami N, et al. Diabetologia. 2004;47:1906-1913. 3. Cooper ME, et al. Diabetes. 2008; 57:1446-1454.
Superior antidiabetic efficacy
Prevention of kidney disease
Up to 64% less dialysis or transplantation
Anti-oxidant properties
Unique free radical scavenger ring
Prolong B-cell life
Satoh J, el al.
Diabetes Research and Clinical Practice 2005
70:291-297
Secondary SU failure: comparison of period until insulin treatment between diabetic patients treated with gliclazide and glibenclamide.
Aim:
To evaluate a possible difference in periods until start of insulin treatment in type 2 diabetic patients Method: Retrospective evaluation of type 2 diabetic patients in a single center from 1981 to 2000 106 patients on Diamicron alone or in combination with other OAD 165 patients on glibenclamide alone or in combination with other OAD Periods until insulin initiation have been calculated with
adjustments for possible coufounding factors between the 2 groups.
Satoh Trial
Intensive & Long lasting glycemic control
Superior control over the long term
-cell mass preservation
Latest ADA/EASD Guidelines For T2D 2009

Chlorpropamide and glibenclamide are associated with a substantially greater risk of hypoglycemia than other 2nd generation sulfonylureas (gliclazide) & their extended formulation which are preferable
Less Effective No Long Term Safety Data Costly
Schramm Study
Schramm study
Aim: the impact of the use different insulin secretagouges (ISs) on log-term major clinical outcomes (Mortality & cardiovascular risk) in type 2 diabetes. Method : 107,806 diabetic patients with or without MI (Danish residents) Initiating single (IS) agent or metformin between1997and 2006 followed up for 9 years
Results
CONTROL Meta-analysis
J. Chalmers, H. Gerstein, W. Duckworth, R. Holmann
ADVANCE ACCORD
VADT
UKPDS
Intensive control and macrovascular outcomes in type 2 diabetes
CONTROL meta analysis
ADVANCE - ACCORD - VADT - UKPDS Collaboration between trial investigators

Hazard Ratio
Major cardiovascular events Myocardial infarction All-cause mortality Stroke 0.91 (0.84-0.99) 0.85 (0.76-0.94) 1.04 (0.91-1.20) 0.96 (0.83-1.10)
CONTROL meta-analysis
Only ADVANCE decreases overall and cardiovascular mortality
Diamicron MR guarantees
Superior control of glycemia
Unique protection of the kidney Unique reduction of cardiovascular death Excellent Practicality
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The Power To Control Glycemia Back To Basic

85% -95% Type2 diabetes

333 million 350

Unique pharmacodynamic properties

Reversible receptor binding:

Diamicron MR acts only when needed

Benefits of Diamicron MRs innovative formulation

Matching Gliclazide release with glycemic circadian variation

Plasmatic concentration (mcg/ml)

Blood glucose level mg/dl

250 200 150 100 50 8 Meal 14 Meal 18 20 Meal 24 4 8

Evidence that others Dont have

The largest morbidity-mortality trial ever performed in type 2 diabetes

Primary end point combined micro- and Macrovascular events

HbA1c target 6.5%

Standard glycemic control

all OADs (except for gliclazide) insulin standard care

Standard glycemic control Intensive glycemic control (Diamicron MR)

Mean HbA1c at final visit

Superior glycemic control

Whatever the severity of the disease

Superior glycemic control

Whatever the patient profile

Superior HbA1c reduction

Whatever the Duration of Diabetes

The lowest ever risk of severe hypoglycemia

Remarkable safety Guide Study

Strict weight neutrality

Strict weight-neutrality over 5 years

1.ADVANCE Group. N Engl J Med 2008; 358:2560-72 /

Strict weight neutrality with Diamicron MR

1.ADVANCE Group. N Engl J Med 2008; 358:2560-72 /

Unique cardiovascular risk reduction

Protect your patients from cardiovascular death

registry. Nephrol. Dial. Transplant. 1991;6(Sup1):5-35.

Major microvascular events

Number (%) of patients with event

526 (9.4%) 605(10.9%)

Diamicron MR protects in particular the kidneys

Number (%) of patients with event

1318 (23.7%) 1434 (25.7%) 162 (2.9%) 231 (4.1%) 0.5

Albuminuria is a well-recognized marker of renal disease and is predictive of increased CV risk

Bring patients Kidney Back to normal

Unique pharmacodynamic properties

Unique free radical scavenger ring

Nephropathy is linked to Oxidative Stress

Superior antidiabetic efficacy

Prevention of kidney disease

Up to 64% less dialysis or transplantation

Unique free radical scavenger ring

Prolong B-cell life

adjustments for possible coufounding factors between the 2 groups.

Intensive & Long lasting glycemic control

Superior control over the long term

-cell mass preservation

Latest ADA/EASD Guidelines For T2D 2009

Less Effective No Long Term Safety Data Costly

Intensive control and macrovascular outcomes in type 2 diabetes

CONTROL meta analysis