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Dr Shahjada Selim
Assistant Professor
Department of Endocrinology
Bangbandhu Sheikh Mujib medical University, Dhaka
Dapagliflozin:
A novel insulin-independent
approach to remove excess glucose
ADA Diabetes Management Algorithm 2015
Three SGLT2is Available
 Canagliflozin (Invokana)
 100mg and 300mg
 Dapagliflozin
(Dapazin/Farxiga)
 5mg and 10mg
 Empagliflozin (Jardiance)
 10 and 25mg
CANAGLIFLOZIN
1. Invokana® (capagliflozin) packageinsert. Titusville (NJ): Janssen Pharmaceuticals; May 2014. 2. Farxiga® (dapagliflozin) package insert.
Prineton (NJ): Bristol-Myers Squibb; Aug 2014. 3. Jardiance® (empagliflozin) package insert. Ridgefield (CT): Boehringer Ingelheim; Aug 2014.
How do they work?
Normal renal glucose handling1–3
SGLT, sodium-glucose co-transporter.
1. Wright EM. Am J Physiol Renal Physiol 2001;280:F10–18; 2. Lee YJ, et al. Kidney Int Suppl 2007;106:S27–35;
3. Hummel CS, et al. Am J Physiol Cell Physiol 2011;300:C14–21.
SGLT2
Glucose
Majority of glucose is
reabsorbed by SGLT2
(90%)
Proximal tubule
Remaining glucose is
reabsorbed by SGLT1
(10%)
Minimal to no
glucose excretion
Glucose
filtration
Dapagliflozin
Proximal tubule
Glucose
filtration
1. FORXIGA Summary of Product Characteristics
Dapagliflozin selectively inhibits SGLT2 in the renal proximal tubule1
SGLT2
Glucose
Dapagliflozin
SGLT2
Dapagliflozin
Increased
urinary glucose
excretion
The benefits of dapagliflozin’s novel
mechanism of action
 Dapagliflozin offers an insulin-
independent mechanism that can be
used as add-on therapy1,4
1. Bailey CJ, et al. Lancet 2010;375:2223–33;
2. FORXIGA Summary of Product Characteristics
The benefits of dapagliflozin’s novel
mechanism of action
 Dapagliflozin inhibition of SGLT2 results in
daily urinary glucose excretion of
approximately 70g,2 providing:
 Significant and sustained HbA1c reductions
versus placebo when added to metformin1,3
 Secondary benefit of weight loss1
1.Bailey CJ, et al. Lancet 2010;375:2223–33;
2. FORXIGA Summary of Product Characteristics
3.Bailey CJ, et al. Poster 988-P. Poster presented at 71st Scientific Sessions of the American Diabetes Association,
San Diego, California, 24–28 June, 2011
Side Effects
 Increased susceptibility
to infection
 Polyuria
 Hypotension
 Hyperkalemia
 Impaired renal function
 Increase in LDL
Urinary tract infection risks
likely to increase as…
 Increased glucose in urine
 Genital mycotic > urinary tract infections
(UTIs)
 At increased risk:
 Females
 11-15% F > 1-8% M
 Dose-independent
Vasilakou D, Karaglannis T, Athanasiadou E, et al. Ann Intern Med. 2013;159:262-74.
Infections
Drug Dose
Urinary tract
infections
Genital mycotic infections
Female Male
Canagliflozin
100mg 5.9% 10.4% 4.2%
300mg 4.3% 11.4% 3.7%
Dapagliflozin
5mg 5.7% 8.4% 2.8%
10mg 4.3% 6.9% 2.7%
Empagliflozin
10mg 9.3% 5.4% 3.1%
25mg 7.6% 6.4% 1.6%
1. Invokana® (capagliflozin) packageinsert. Titusville (NJ): Janssen Pharmaceuticals; May 2014. 2. Farxiga® (dapagliflozin) package insert. Prineton (NJ): Bristol-Myers Squibb; Aug 2014.
3. Jardiance® (empagliflozin) package insert. Ridgefield (CT): Boehringer Ingelheim; Aug 2014. 4. Yang XP, Lai D, Zhong XY, et al. Eur J Clin Pharmacol. 2014; 70:1149-58.
5. Zang M, Zhang L, Wu B, et al. Diabetes Metab Res Rev. 2014;30:204-21. 6. Liakos A, Karagiannis T, Athanasiadou E, et al. Diabetes Obes Metab. 2014; 16: 984-93.
Dapagliflozin- a novel SGLT2 inhibitor
Kidney Function
 Osmotic diuresis & volume depletion
 Polyuria (including nocturia) resulting in dehydration,
hypovolemia, syncope, etc.
 Increased risk if > 75yo, eGFR < 60ml/min or on loop
diuretics
 Dose-dependent decrease in blood pressure
 Systolic BP 3-6mmHg
 Diastolic BP 1-2mmHg
1. Vasilakou D, Karaglannis T, Athanasiadou E, et al. Ann Intern Med. 2013;159:262-74.
2. Fujita Y, Inagaki Y. J Diabetes Invest. 2014;5:265-75.
Dapagliflozin: Reductions in HbA1c were sustained over 102 weeks
Data are mean change from baseline after adjustment for baseline value. Data after rescue are excluded.Analyses were obtained by
longitudinal repeated measures analyses. CI, confidence interval.
Adapted from Bailey CJ et al. Poster #988-P. Poster presented at 71st Scientific Sessions of the American Diabetes Association, San Diego, California, June
24–28, 2011.
Study week
–1.2
–0.8
–0.6
–0.4
0.2
0 16 37 50 63 76 10289
0.0
HbA1c(%)
meanchangefrombaseline
8 24
Primary endpoint
–1.0
–0.2
–5
0
–10
Dapagliflozin 10 mg +
metformin
(Mean baseline HbA1c 7.92% [63
mmol/mol])
Placebo + metformin
(Mean baseline HbA1c 8.11% [65
mmol/mol])
(n=133)
(n=132)
HbA1c(mmol/mol)
meanchangefrombaseline
+0.02%
(0.2
mmol/mol)
(95% Cl,
–0.20 to 0.23%;
n=28)
–0.78%
(–8.5 mmol/mol)
(95% Cl,
–0.97 to –0.60%;
n=57)
0.80%
(8.8 mmol/mol)
difference
1. Ferrannini E et al. Diabetes Care 2010;33:2217–2224. 2. Bailey CJ et al. Lancet 2010;375:2223–2233.
3. Strojek K et al. Diabetes Obes Metab 2011;13:928–938. 4. Wilding JPH et al. Ann Intern Med 2012;156:405–415.
Dapagliflozin: Consistent reduction in HbA1c at Week 24 across studies
Baseline HbA1c:
7.91%; 63 mmol/mol
MeanchangeinHbA1c(%)
–0.23
(-3 mmol/mol)
–0.89*
(-10 mmol/mol)
–0.84*
(-9 mmol/mol)
–0.30
(-3 mmol/mol)
–0.82*
(-9 mmol/mol)
–0.13
(-1 mmol/mol)
–0.96*
(-10 mmol/mol)
–0.39
(-4 mmol/mol)
Baseline HbA1c:
8.05%; 64 mmol/mol
Baseline HbA1c:
8.11%;
65 mmol/mol
Baseline HbA1c:
8.53%; 70 mmol/mol
Add-on to a
SU3
Add-on to metformin2Monotherapy1 Add-on to insulin4
These data are taken from different studies and the results should not be compared across studies.
*Statistically significant vs. placebo using Dunnett’s correction.SU, sulphonylurea.
Dapagliflozin (10 mg)
Placebo
p<0.0001 p<0.0001 p<0.0001 p<0.001
Dapagliflozin: secondary benefit of weight loss over 102
weeks
 Weight loss at 24 weeks, with decreased waist circumference is consistent with a reduction of body-fat mass 1
 In a separate study, weight loss was mainly attributable to reduction in body fat mass rather than loss of fluid or lean
tissue3 #
Adjustedmeanchange
frombaselinebodyweight(kg)
24 weeks (LOCF analysis)1
–1.70 kg
(n=95)
95% Cl
(-2.48 to -0.91)
–2.9 kg
(n=133)
95% CI
(-3.3 to -2.4)
–0.9 kg
(n=136) 95%CI
-1.4 to -0.4
2.0 kg
difference
p<0.0001
+1.36 kg
(n=73)
95% Cl
(0.53 to 2.20)
3.1 kg
difference
p value not
calculated
Data are mean change from baseline after adjustment for baseline value (mean baseline weight: dapagliflozin 86.3 kg, placebo 87.7 kg).
24-week data are based on LOCF analysis excluding data after rescue; 102-week data are based on longitudinal repeated measures analysis and include data
after rescue.
# As measured by dual energy absorptiometry at 24 weeks
1. Bailey CJ, et al. Lancet 2010;375:2223–33; 2. Bailey CJ, et al. Poster 988-P. Poster presented at 71st Scientific Sessions of the American Diabetes
Association, San Diego, California, June 24–28, 2011; 3. Bolinder J, et al. J Clin Endocrinol Metab 2012;97:1020–31.
102 weeks (repeated measures analysis)2
Dapagliflozin 10 mg
+ metformin
Dapagliflozin 10 mg
+ metformin
Placebo
+ metformin
Placebo
+ metformin
Adapted from Bailey CJ, et al. (2010) & Bailey CJ, et al. (2011)
Reductions in HbA1c with insulin + dapagliflozin
compared with insulin + placebo at 24 weeks
1. Wilding J, et al. Ann Intern Med 2012;156:405–415.
2. FORXIGA™. Summary of product characteristics.
Adapted from Wilding J, et al. 2012
Last observation carried forward (LOCF). Data are adjusted mean change from baseline. Mean HbA1c at baseline were 8.47% (69
mmol/mol) for insulin + placebo and 8.57% (70 mmol/mol) for insulin + dapagliflozin 10mg.
Consider a reduction in insulin dose on commencement of dapagliflozin to reduce the risk of hypoglycaemia2
-1.0
-0.8
-0.6
-0.4
-0.2
0.0
Adjustedmeanchangefrom
baselineHbA1c(%)
Adjustedmeanchangefrom
baselineHbA1c(mmol/mol)
Dapagliflozin 10 mg +
insulin
Placebo +
insulin
–0.96%
(–10.5 mmol/mol)
(n=194)
–0.39%
(–4.3 mmol/mol)
(n=193)
0.57% (6.2 mmol/mol)
difference
(95% CI, –0.72 to –0.42%)
p<0.001
-10
-5
0
Uptitration of insulin dosing is less pronounced in patients treated
with insulin + dapagliflozin compared with insulin + placebo ± OADs
1. Wilding JPH et al. Ann Intern Med 2012;156:405–415.
2. FORXIGA™. Summary of product characteristics..
Dapagliflozin
190
 Change in total daily insulin dose (units)
from baseline1:
At 24 weeks
placebo + insulin – 8% increase
dapagliflozin + insulin – 1.5% decrease
At 48 weeks
placebo + insulin – 14% increase
dapagliflozin + insulin – 1% decrease
 Patients needing rescue therapy or
withdrawn from study for not achieving
glycaemic targets:1
Placebo + insulin – 42.8%
dapagliflozin 10mg + insulin – 15.3%
 Baseline mean daily insulin dose (units):
• Insulin + placebo = 73.7
• Insulin + dapagliflozin 10mg = 78.0
• Consider a reduction in insulin dose on
commencement of dapagliflozin to
reduce the risk of hypoglycaemia2
Dapagliflozin
Group
A1c Reduction (%) FPG Reduction (mg/dl)
5mg 10mg 5mg 10mg
Monotherapy -0.5 -0.7 -19.9 -24.7
Add-on
metformin
-0.4 -0.5 -15.5 -17.5
Add-on
glimepiride
-0.5 -0.7 -19.3 -26.5
Add-on
pioglitazone
-0.4 -0.6 -19.5 -24.1
Add-on insulin -0.5 -0.6 -- -25
Add-on 3 drug
regimen
-- -0.48 -- -27.9
1. Farxiga® (dapagliflozin) package insert. Prineton (NJ): Bristol-Myers Squibb; Aug 2014.
2. Zang M, Zhang L, Wu B, et al. Diabetes Metab Res Rev. 2014;30:204-21.
Weight Loss
Group Low Dose (kg) High Dose (kg)
Canagliflozin 2.2 3.3
Canagliflozin +
Insulin
1.9 2.4
Dapagliflozin 2.2 2
Dapagliflozin +
insulin
1 1.7
Empagliflozin 2.5 2.8
Empagliflozin +
insulin
3 3
1. Invokana® (capagliflozin) packageinsert. Titusville (NJ): Janssen Pharmaceuticals; May 2014. 2. Farxiga® (dapagliflozin) package insert. Prineton (NJ): Bristol-Myers Squibb; Aug 2014.
3. Jardiance® (empagliflozin) package insert. Ridgefield (CT): Boehringer Ingelheim; Aug 2014. 4. Yang XP, Lai D, Zhong XY, et al. Eur J Clin Pharmacol. 2014; 70:1149-58.
5. Zang M, Zhang L, Wu B, et al. Diabetes Metab Res Rev. 2014;30:204-21. 6. Liakos A, Karagiannis T, Athanasiadou E, et al. Diabetes Obes Metab. 2014; 16: 984-93.
Hypoglycemia
 Insulin-independent mechanism of action
 Low risk when used as monotherapy
 Comparable to that of metformin or sitagliptin
 Increased risk with insulin and insulin secretagogues
 SGLT2is lower the renal reabsorption of glucose
threshold without completely inhibiting it
 Renal threshold of < 70mg/dL
1. Chen LH, Leung PS. Diabetes Obes Metab. 2013;15:392-402.
2. Jung CH, Jang JE, Park JY. Diabetes Metab J 2014;38261-73.
3.. Fujita Y, Inagaki Y. J Diabetes Invest. 2014;5:265-75.
Dapagliflozin: Hypoglycemia
Group
Hypoglycemic Events
Minor Major
5mg 10mg 5mg 10mg
Monotherapy 0% 0% 0% 0%
Add-on
metformin
1.5% 0.7% 0% 0%
Add-on
glimepiride
5.5% 6.0% 0% 0%
Add-on
pioglitazone
2.1% 0% 0% 0%
Add-on
insulin
43.4% 40.3% 0.5% 0.5%
1. Farxiga® (dapagliflozin) package insert. Prineton (NJ): Bristol-Myers Squibb; Aug 2014. 2. Zang M, Zhang L, Wu B, et al. Diabetes Metab Res Rev. 2014;30:204-21.
Evidences…..
Dapagliflozin- a novel SGLT2 inhibitor
Dapagliflozin- a novel SGLT2 inhibitor
Dapagliflozin- a novel SGLT2 inhibitor
1.1 Dapagliflozin in a dual therapy regimen in
combination with metformin is recommended as
an option for treating type 2 diabetes, only if it is
used as described for dipeptidyl peptidase-4
(DPP-4) inhibitors inType 2 diabetes: the
management of type 2 diabetes (NICE clinical
guideline 87).
NICE TA288
http://publications.nice.org.uk/dapagliflozin-in-combination-
therapy-for-treating-type-2-diabetes-ta288
1.2 Dapagliflozin in combination with insulin with or without
other antidiabetic drugs is recommended as an option for
treating type 2 diabetes.
1.3 Dapagliflozin in a triple therapy regimen in combination with
metformin and a sulfonylurea is not recommended for treating
type 2 diabetes, except as part of a clinical trial.
NICE TA288
http://publications.nice.org.uk/dapagliflozin-in-combination-
therapy-for-treating-type-2-diabetes-ta288
Dapagliflozin- a novel SGLT2 inhibitor
Dapagliflozin- a novel SGLT2 inhibitor
Dapagliflozin- a novel SGLT2 inhibitor
Dapagliflozin- a novel SGLT2 inhibitor
Dapagliflozin- a novel SGLT2 inhibitor
Dapagliflozin- a novel SGLT2 inhibitor
Dapagliflozin- a novel SGLT2 inhibitor
THANKS
Questions?

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Dapagliflozin- a novel SGLT2 inhibitor

  • 1. Dr Shahjada Selim Assistant Professor Department of Endocrinology Bangbandhu Sheikh Mujib medical University, Dhaka Dapagliflozin: A novel insulin-independent approach to remove excess glucose
  • 2. ADA Diabetes Management Algorithm 2015
  • 3. Three SGLT2is Available  Canagliflozin (Invokana)  100mg and 300mg  Dapagliflozin (Dapazin/Farxiga)  5mg and 10mg  Empagliflozin (Jardiance)  10 and 25mg CANAGLIFLOZIN 1. Invokana® (capagliflozin) packageinsert. Titusville (NJ): Janssen Pharmaceuticals; May 2014. 2. Farxiga® (dapagliflozin) package insert. Prineton (NJ): Bristol-Myers Squibb; Aug 2014. 3. Jardiance® (empagliflozin) package insert. Ridgefield (CT): Boehringer Ingelheim; Aug 2014.
  • 4. How do they work?
  • 5. Normal renal glucose handling1–3 SGLT, sodium-glucose co-transporter. 1. Wright EM. Am J Physiol Renal Physiol 2001;280:F10–18; 2. Lee YJ, et al. Kidney Int Suppl 2007;106:S27–35; 3. Hummel CS, et al. Am J Physiol Cell Physiol 2011;300:C14–21. SGLT2 Glucose Majority of glucose is reabsorbed by SGLT2 (90%) Proximal tubule Remaining glucose is reabsorbed by SGLT1 (10%) Minimal to no glucose excretion Glucose filtration
  • 6. Dapagliflozin Proximal tubule Glucose filtration 1. FORXIGA Summary of Product Characteristics Dapagliflozin selectively inhibits SGLT2 in the renal proximal tubule1 SGLT2 Glucose Dapagliflozin SGLT2 Dapagliflozin Increased urinary glucose excretion
  • 7. The benefits of dapagliflozin’s novel mechanism of action  Dapagliflozin offers an insulin- independent mechanism that can be used as add-on therapy1,4 1. Bailey CJ, et al. Lancet 2010;375:2223–33; 2. FORXIGA Summary of Product Characteristics
  • 8. The benefits of dapagliflozin’s novel mechanism of action  Dapagliflozin inhibition of SGLT2 results in daily urinary glucose excretion of approximately 70g,2 providing:  Significant and sustained HbA1c reductions versus placebo when added to metformin1,3  Secondary benefit of weight loss1 1.Bailey CJ, et al. Lancet 2010;375:2223–33; 2. FORXIGA Summary of Product Characteristics 3.Bailey CJ, et al. Poster 988-P. Poster presented at 71st Scientific Sessions of the American Diabetes Association, San Diego, California, 24–28 June, 2011
  • 9. Side Effects  Increased susceptibility to infection  Polyuria  Hypotension  Hyperkalemia  Impaired renal function  Increase in LDL
  • 10. Urinary tract infection risks likely to increase as…  Increased glucose in urine  Genital mycotic > urinary tract infections (UTIs)  At increased risk:  Females  11-15% F > 1-8% M  Dose-independent Vasilakou D, Karaglannis T, Athanasiadou E, et al. Ann Intern Med. 2013;159:262-74.
  • 11. Infections Drug Dose Urinary tract infections Genital mycotic infections Female Male Canagliflozin 100mg 5.9% 10.4% 4.2% 300mg 4.3% 11.4% 3.7% Dapagliflozin 5mg 5.7% 8.4% 2.8% 10mg 4.3% 6.9% 2.7% Empagliflozin 10mg 9.3% 5.4% 3.1% 25mg 7.6% 6.4% 1.6% 1. Invokana® (capagliflozin) packageinsert. Titusville (NJ): Janssen Pharmaceuticals; May 2014. 2. Farxiga® (dapagliflozin) package insert. Prineton (NJ): Bristol-Myers Squibb; Aug 2014. 3. Jardiance® (empagliflozin) package insert. Ridgefield (CT): Boehringer Ingelheim; Aug 2014. 4. Yang XP, Lai D, Zhong XY, et al. Eur J Clin Pharmacol. 2014; 70:1149-58. 5. Zang M, Zhang L, Wu B, et al. Diabetes Metab Res Rev. 2014;30:204-21. 6. Liakos A, Karagiannis T, Athanasiadou E, et al. Diabetes Obes Metab. 2014; 16: 984-93.
  • 13. Kidney Function  Osmotic diuresis & volume depletion  Polyuria (including nocturia) resulting in dehydration, hypovolemia, syncope, etc.  Increased risk if > 75yo, eGFR < 60ml/min or on loop diuretics  Dose-dependent decrease in blood pressure  Systolic BP 3-6mmHg  Diastolic BP 1-2mmHg 1. Vasilakou D, Karaglannis T, Athanasiadou E, et al. Ann Intern Med. 2013;159:262-74. 2. Fujita Y, Inagaki Y. J Diabetes Invest. 2014;5:265-75.
  • 14. Dapagliflozin: Reductions in HbA1c were sustained over 102 weeks Data are mean change from baseline after adjustment for baseline value. Data after rescue are excluded.Analyses were obtained by longitudinal repeated measures analyses. CI, confidence interval. Adapted from Bailey CJ et al. Poster #988-P. Poster presented at 71st Scientific Sessions of the American Diabetes Association, San Diego, California, June 24–28, 2011. Study week –1.2 –0.8 –0.6 –0.4 0.2 0 16 37 50 63 76 10289 0.0 HbA1c(%) meanchangefrombaseline 8 24 Primary endpoint –1.0 –0.2 –5 0 –10 Dapagliflozin 10 mg + metformin (Mean baseline HbA1c 7.92% [63 mmol/mol]) Placebo + metformin (Mean baseline HbA1c 8.11% [65 mmol/mol]) (n=133) (n=132) HbA1c(mmol/mol) meanchangefrombaseline +0.02% (0.2 mmol/mol) (95% Cl, –0.20 to 0.23%; n=28) –0.78% (–8.5 mmol/mol) (95% Cl, –0.97 to –0.60%; n=57) 0.80% (8.8 mmol/mol) difference
  • 15. 1. Ferrannini E et al. Diabetes Care 2010;33:2217–2224. 2. Bailey CJ et al. Lancet 2010;375:2223–2233. 3. Strojek K et al. Diabetes Obes Metab 2011;13:928–938. 4. Wilding JPH et al. Ann Intern Med 2012;156:405–415. Dapagliflozin: Consistent reduction in HbA1c at Week 24 across studies Baseline HbA1c: 7.91%; 63 mmol/mol MeanchangeinHbA1c(%) –0.23 (-3 mmol/mol) –0.89* (-10 mmol/mol) –0.84* (-9 mmol/mol) –0.30 (-3 mmol/mol) –0.82* (-9 mmol/mol) –0.13 (-1 mmol/mol) –0.96* (-10 mmol/mol) –0.39 (-4 mmol/mol) Baseline HbA1c: 8.05%; 64 mmol/mol Baseline HbA1c: 8.11%; 65 mmol/mol Baseline HbA1c: 8.53%; 70 mmol/mol Add-on to a SU3 Add-on to metformin2Monotherapy1 Add-on to insulin4 These data are taken from different studies and the results should not be compared across studies. *Statistically significant vs. placebo using Dunnett’s correction.SU, sulphonylurea. Dapagliflozin (10 mg) Placebo p<0.0001 p<0.0001 p<0.0001 p<0.001
  • 16. Dapagliflozin: secondary benefit of weight loss over 102 weeks  Weight loss at 24 weeks, with decreased waist circumference is consistent with a reduction of body-fat mass 1  In a separate study, weight loss was mainly attributable to reduction in body fat mass rather than loss of fluid or lean tissue3 # Adjustedmeanchange frombaselinebodyweight(kg) 24 weeks (LOCF analysis)1 –1.70 kg (n=95) 95% Cl (-2.48 to -0.91) –2.9 kg (n=133) 95% CI (-3.3 to -2.4) –0.9 kg (n=136) 95%CI -1.4 to -0.4 2.0 kg difference p<0.0001 +1.36 kg (n=73) 95% Cl (0.53 to 2.20) 3.1 kg difference p value not calculated Data are mean change from baseline after adjustment for baseline value (mean baseline weight: dapagliflozin 86.3 kg, placebo 87.7 kg). 24-week data are based on LOCF analysis excluding data after rescue; 102-week data are based on longitudinal repeated measures analysis and include data after rescue. # As measured by dual energy absorptiometry at 24 weeks 1. Bailey CJ, et al. Lancet 2010;375:2223–33; 2. Bailey CJ, et al. Poster 988-P. Poster presented at 71st Scientific Sessions of the American Diabetes Association, San Diego, California, June 24–28, 2011; 3. Bolinder J, et al. J Clin Endocrinol Metab 2012;97:1020–31. 102 weeks (repeated measures analysis)2 Dapagliflozin 10 mg + metformin Dapagliflozin 10 mg + metformin Placebo + metformin Placebo + metformin Adapted from Bailey CJ, et al. (2010) & Bailey CJ, et al. (2011)
  • 17. Reductions in HbA1c with insulin + dapagliflozin compared with insulin + placebo at 24 weeks 1. Wilding J, et al. Ann Intern Med 2012;156:405–415. 2. FORXIGA™. Summary of product characteristics. Adapted from Wilding J, et al. 2012 Last observation carried forward (LOCF). Data are adjusted mean change from baseline. Mean HbA1c at baseline were 8.47% (69 mmol/mol) for insulin + placebo and 8.57% (70 mmol/mol) for insulin + dapagliflozin 10mg. Consider a reduction in insulin dose on commencement of dapagliflozin to reduce the risk of hypoglycaemia2 -1.0 -0.8 -0.6 -0.4 -0.2 0.0 Adjustedmeanchangefrom baselineHbA1c(%) Adjustedmeanchangefrom baselineHbA1c(mmol/mol) Dapagliflozin 10 mg + insulin Placebo + insulin –0.96% (–10.5 mmol/mol) (n=194) –0.39% (–4.3 mmol/mol) (n=193) 0.57% (6.2 mmol/mol) difference (95% CI, –0.72 to –0.42%) p<0.001 -10 -5 0
  • 18. Uptitration of insulin dosing is less pronounced in patients treated with insulin + dapagliflozin compared with insulin + placebo ± OADs 1. Wilding JPH et al. Ann Intern Med 2012;156:405–415. 2. FORXIGA™. Summary of product characteristics.. Dapagliflozin 190  Change in total daily insulin dose (units) from baseline1: At 24 weeks placebo + insulin – 8% increase dapagliflozin + insulin – 1.5% decrease At 48 weeks placebo + insulin – 14% increase dapagliflozin + insulin – 1% decrease  Patients needing rescue therapy or withdrawn from study for not achieving glycaemic targets:1 Placebo + insulin – 42.8% dapagliflozin 10mg + insulin – 15.3%  Baseline mean daily insulin dose (units): • Insulin + placebo = 73.7 • Insulin + dapagliflozin 10mg = 78.0 • Consider a reduction in insulin dose on commencement of dapagliflozin to reduce the risk of hypoglycaemia2
  • 19. Dapagliflozin Group A1c Reduction (%) FPG Reduction (mg/dl) 5mg 10mg 5mg 10mg Monotherapy -0.5 -0.7 -19.9 -24.7 Add-on metformin -0.4 -0.5 -15.5 -17.5 Add-on glimepiride -0.5 -0.7 -19.3 -26.5 Add-on pioglitazone -0.4 -0.6 -19.5 -24.1 Add-on insulin -0.5 -0.6 -- -25 Add-on 3 drug regimen -- -0.48 -- -27.9 1. Farxiga® (dapagliflozin) package insert. Prineton (NJ): Bristol-Myers Squibb; Aug 2014. 2. Zang M, Zhang L, Wu B, et al. Diabetes Metab Res Rev. 2014;30:204-21.
  • 20. Weight Loss Group Low Dose (kg) High Dose (kg) Canagliflozin 2.2 3.3 Canagliflozin + Insulin 1.9 2.4 Dapagliflozin 2.2 2 Dapagliflozin + insulin 1 1.7 Empagliflozin 2.5 2.8 Empagliflozin + insulin 3 3 1. Invokana® (capagliflozin) packageinsert. Titusville (NJ): Janssen Pharmaceuticals; May 2014. 2. Farxiga® (dapagliflozin) package insert. Prineton (NJ): Bristol-Myers Squibb; Aug 2014. 3. Jardiance® (empagliflozin) package insert. Ridgefield (CT): Boehringer Ingelheim; Aug 2014. 4. Yang XP, Lai D, Zhong XY, et al. Eur J Clin Pharmacol. 2014; 70:1149-58. 5. Zang M, Zhang L, Wu B, et al. Diabetes Metab Res Rev. 2014;30:204-21. 6. Liakos A, Karagiannis T, Athanasiadou E, et al. Diabetes Obes Metab. 2014; 16: 984-93.
  • 21. Hypoglycemia  Insulin-independent mechanism of action  Low risk when used as monotherapy  Comparable to that of metformin or sitagliptin  Increased risk with insulin and insulin secretagogues  SGLT2is lower the renal reabsorption of glucose threshold without completely inhibiting it  Renal threshold of < 70mg/dL 1. Chen LH, Leung PS. Diabetes Obes Metab. 2013;15:392-402. 2. Jung CH, Jang JE, Park JY. Diabetes Metab J 2014;38261-73. 3.. Fujita Y, Inagaki Y. J Diabetes Invest. 2014;5:265-75.
  • 22. Dapagliflozin: Hypoglycemia Group Hypoglycemic Events Minor Major 5mg 10mg 5mg 10mg Monotherapy 0% 0% 0% 0% Add-on metformin 1.5% 0.7% 0% 0% Add-on glimepiride 5.5% 6.0% 0% 0% Add-on pioglitazone 2.1% 0% 0% 0% Add-on insulin 43.4% 40.3% 0.5% 0.5% 1. Farxiga® (dapagliflozin) package insert. Prineton (NJ): Bristol-Myers Squibb; Aug 2014. 2. Zang M, Zhang L, Wu B, et al. Diabetes Metab Res Rev. 2014;30:204-21.
  • 27. 1.1 Dapagliflozin in a dual therapy regimen in combination with metformin is recommended as an option for treating type 2 diabetes, only if it is used as described for dipeptidyl peptidase-4 (DPP-4) inhibitors inType 2 diabetes: the management of type 2 diabetes (NICE clinical guideline 87). NICE TA288 http://publications.nice.org.uk/dapagliflozin-in-combination- therapy-for-treating-type-2-diabetes-ta288
  • 28. 1.2 Dapagliflozin in combination with insulin with or without other antidiabetic drugs is recommended as an option for treating type 2 diabetes. 1.3 Dapagliflozin in a triple therapy regimen in combination with metformin and a sulfonylurea is not recommended for treating type 2 diabetes, except as part of a clinical trial. NICE TA288 http://publications.nice.org.uk/dapagliflozin-in-combination- therapy-for-treating-type-2-diabetes-ta288

Notas del editor

  1. The three c-glucosidase SGLT2 inhibitors available are cana-, dapa- and empa-gliflozin. There are several others being researched and undergoing trials. The first to be approved was canagliflozin in January of 2013. It was approved in two dosage strengths, 100 and 300mg. However, 100mg is the maximum dose for CrCl < 45-60ml/min and use is not recommended in CrCl < 30-45ml/min - Increase in non-fatal stroke? Dapagliflozin was the second to be FDA approved in January of 2014 also in two dosage strengths with recommendations to avoid use in CrCl < 60 ml/min. However, dapagliflozin was actually the first SGLT2 to complete phase III trials and the first to be presented to the FDA for approval. However, the FDA denied its first application stating the increased incidence of bladder and breast cancer seen in clinical trials warranted further study before approval. Thus after several additional long term studies it was approved a year after canagliflozin. The increased incidence of bladder cancer was 10 cases out of 6045 or 0.17% compared to 1 out of 3512 or 0.1% in placebo/active comparators and the increased incidence of breast cancer was 12 cases in 2693 or 0.45% compared to 3 out of 1439 or 0.45% in placebo/active comparators. The exact relationship between dapagliflozin and these cancers is uncertain as majority of the studies were less than 90 week durations and these cancers typically take years to develop. Empagliflozin was recently approved by the FDA in August of 2014. Again it was approved at two dosage strengths and is not recommended in CrCl < 45ml/min. Empagliflozin was developed as it is the most selective for the SGLT2 receptor out of the available drugs. Thus it was believed to have the potential to be safer and/or more effective.
  2. 7
  3. 8
  4. By understanding this mechanism of action and the other consequences of inhibiting glucose reabsorption, such as reduction of sodium and water reabsorption as well as potential reduced excretion of potassium, one begin to hypothesize the potential side effects of this class of medications.
  5. Avoid use in CrCl <45-60ml/min Dose-dependent decrease in eGFR (~2-6ml/min) Pre-renal, not direct renal injury Volume depletion 1-3% 3-8% if >75yo, eGFR<60, or on loop diuretics Glycemic efficacy declines with decreased renal function However, improves overtime (~1-3ml/min) Helps prevent and improve albuminuria
  6. 14
  7. 16
  8. So then dapagliflozin, again you see a slight decrease with combination therapy in comparison to monotherapy but not as significant as with canagliflozin. You also see some added benefit with the increased dose from 5mg to 10mg, however again not as significant as with canagliflozin. Presumably due to this lack of significant difference and improved glycemic control with the higher dose of 10mg, many studies did not even include the 5mg dose. Dapagliflozin was studied as third add on treatment with either metformin and sitagliptin or insulin and an oral antidiabetic agent (most often metformin).
  9. Add on glimepiride: in comparison to placebo (glimepiride alone) with 2.1% minor and 0% major Add on insulin: in comparison to placebo (insulin +/- OADs alone) with 34% minor and 0.5% major