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Diabetes Care Update 2016
Thursday, February 25, 20162:00 PM – 3:00 PM ET
Speaker
Jennifer D. Smith, PharmD, CPP, BC-ADM, CDE
Associate Professor
Campbell University College of Pharmacy & Health Sciences
Clinical Pharmacist Practitioner
Wilson Community Health Center
Wilson, North Carolina
Disclosures
Jennifer D. Smith, PharmD, CPP, BC-ADM, CDE, and APhA’s editorial staff declare no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this activity, including grants, employment, gifts, stock holdings, and honoraria.
For complete staff disclosures, please go to APhA’s Accreditation Information webpage at www.pharmacist.com/apha-disclosures.
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 1
Development and Support
This activity was developed by the American Pharmacists Association and supported by an independent educational grant from The Kroger Company.
Attendance Code (live webinar only)
DM16To obtain CPE credit for this live webinar, you are required to actively participate in the entire activity. The attendance code is needed to access the assessment questions to complete the CPE form for this activity. Detailed information on how to claim credit will be provided at the end of the webinar.
Your CPE must be filed by March 25, 2016 at 5:00 PM ET in order to receive credit.
Accreditation Information
The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This activity, Diabetes Care Update 2016, is approved for 1 hour of continuing pharmacy education
credit (0.1 CEUs). The ACPE Universal Activity Number assigned by the accredited provider is: 0202-0000-16-088-L04-P.
To obtain continuing pharmacy education credit for this activity, participants will be required to actively participate in the entire webinar and complete an assessment and evaluation by March 25, 2016.
Initial Release Date: February 25, 2016Target Audience: Kroger pharmacists providing the best diabetes careActivity Type: Application-basedLearning Level: 2Fee: There is no fee to participate in this activity
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 2
Learning Objectives
Summarize important recent changes to the American Diabetes Association (ADA) Standards of Medical Care in Diabetes and other authoritative guidelines.
Describe evidence regarding the risks and benefits of new and emerging medications and products for the management of patients with diabetes.
Identify noteworthy findings from recent large clinical trials that have potential to influence diabetes care.
Explain how to apply emerging information to the care of patients with diabetes.
Question 1SGLT2 inhibitors have been associated with:
A. Joint pain
B. Heart failure
C. Euglycemic diabetic ketoacidosis (DKA)
D. Worsening albuminuria
Question 2In which disease state should DPP-4 inhibitor treatment be used cautiously?
A. Mild renal impairment
B. Rheumatoid arthritis
C. Recurrent UTI
D. Osteoporosis
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 3
Question 3Which was a finding of the treatment arm in the EMPA-REG Outcome Study?
A. Increased incidence of DKA
B. Increased incidence of bone fractures
C. Decreased incidence of genital infections
D. Decreased incidence of cardiovascular (CV) death
ADA STANDARDS OF MEDICAL CARE IN DIABETES—2016
Strategies for Improving Care
Recognizes the impact of food insecurity, homelessness, cognitive impairment, and HIV on glycemic control
– Glipizide as preferred sulfonylurea in food insecurity
– Second-generation antipsychotic: monitor changes in weight, blood glucose, and cholesterol and reassess treatment regimen
– Patients with HIV should be screened for diabetes and pre-diabetes with a fasting glucose level before starting antiretroviral therapy and 3 months after starting or changing it
• Normal: check annually
• Pre-diabetes: measure every 3-6 months to monitor for progression
Diabetes Care. 2016;39:S6–S12.
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 4
Classification and Diagnosis of Diabetes
Test all adults at age ≥45 years for diabetes, regardless of weight
Test at any age if overweight/obese and 1+ risk factors for diabetes
Diabetes Care. 2016;39:S13–S22.
Obesity Management for Treatment of T2D
• >16 sessions in 6 months
• Focus on diet, physical activity, and behavioral therapy
• Goal: 500-750 kcal/day energy deficit
• Weight loss medications considered if BMI >27 kg/m2
• Bariatric surgery considered if BMI >35 kg/m2
High-intensity plan to achieve 5% weight loss
• Monthly contact
• Monitor body weight (weekly or more frequently)
• Continue reduced caloric intake
• High levels of physical activity (200–300 minutes/week)
Weight maintenance
program
Diabetes Care. 2016;39:S47–S51.
CV Disease and Risk Management
Pharmacologic treatment to achieve goals of <130/70 mm Hg in older adults is not recommended
Lipid profile if not taking statin: at diabetes diagnosis, at initial medical evaluation, and every 5 years thereafter
Fasting triglyceride levels >500 mg/dL: consider treatment to reduce the risk of pancreatitis
Addition of ezetimibe to moderate-intensity statin therapy may provide additional cardiovascular benefit
– Recent acute coronary syndrome with LDL-C >50 mg/dL
– Cannot tolerate high-intensity statin therapy
Diabetes Care. 2016;39:S60–S71.
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 5
CV Disease and Risk Management
Aspirin (75–162 mg/day) for primary prevention in patients at increased risk
– 10-year risk >10%
– Includes men and women >50 years with 1+ major risk factor
Aspirin should not be recommended for patients at low risk
– 10-year risk <5%
– Includes men and women <50 years with no major CV disease risk factors
Clinical judgment for patients with 10-year risk of 5% to 10%
Diabetes Care. 2016;39:S60–S71.
Microvascular Complications
Refer patients for evaluation for renal replacement treatment when eGFR is <30 mL/min/1.73 m2
Diabetes Care. 2016;39:S72–S80.
Older Adults
Assess medical, functional, mental, and social geriatric domains for older diabetics to determine targets and therapeutic approaches
Avoid hypoglycemia: may require adjusting glycemic targets and pharmacological interventions
When palliative care is needed, blood pressure control and intensity of lipid management may be relaxed and therapy adjusted or withdrawn
Diabetes Care. 2016;39:S81–S85.
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 6
AACE/ACE CONSENSUS STATEMENT ON THE COMPREHENSIVE TYPE 2 DIABETES (T2D) MANAGEMENT ALGORITHM – 2016
Metformin and B12 Levels
Vitamin B12 levels should be monitored in all patients taking metformin
B12 supplements should be given to affected patients
AACE/ACE Consensus Statement. Endocr Pract. 2016;22(1):84–113.
Blood Pressure Control
<130/80 mm Hg appropriate for most
• Less stringent if frail, complicated comorbidities, or adverse medication effects
• More stringent (e.g., <120/80 mm Hg) if can be reached safely
AACE/ACE Consensus Statement. Endocr Pract. 2016;22(1):84–113.
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 7
Lipid Management
High Risk: T2D but no other major risk and/or
age <40 yrs
Very High Risk: T2D (+) >1 major ASCVD risk or established ASCVD
LDL-C (mg/dL) <100 <70
Non-HDL-C (mg/dL) <130 <100
Triglycerides (mg/dL) <150 <150
TC/HDL-C <3.5 <3.0
Apo B (mg/dL) <90 <80
LDL-P (nmol/L) <1,200 <1,000
AACE/ACE Consensus Statement. Endocr Pract. 2016;22(1):84–113.
Insulin Intensification (Prandial Control)
Basal insulin on board but further glycemic control needed:
GLP-1 RA
SGLT2 inhibitor
DPP-4 inhibitor
Prandial insulin
– Basal Plus 1, Plus 2, Plus 3
– 50/50 Basal/Bolus as prandial insulin before each meal based on total daily dose of 0.3–0.5 units/kg
AACE/ACE Consensus Statement. Endocr Pract. 2016;22(1):84–113.
JOINT POSITION STATEMENT OF THE AMERICAN DIABETES ASSOCIATION, THE AMERICAN ASSOCIATION OF DIABETES EDUCATORS, AND THE ACADEMY OF NUTRITION AND DIETETICS
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 8
Diabetes Self-Management Education and Support DSME: provision of knowledge and skills necessary to manage
diabetes
– What is diabetes
– How to use a blood glucose meter
– Insulin injection technique
DSMS: support necessary for implementing and maintaining coping skills and behaviors to self-manage the disease
– Refresher courses
– Support groups
– Magazine subscriptionsPowers MA, et al. The Diabetes Educator. 2015;41(4):417–30.
DSME and DSMS for T2D
Powers MA, et al. The Diabetes Educator. 2015;41(4):417–30.
SAFETY COMMUNICATIONS
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 9
Multidose Diabetes Pens
“For single patient use only”
www.fda.gov/Drugs/DrugSafety/ucm435271.htm
Repaglinide and Clopidogrel
Clopidogrel inhibits CYP2C8
May inhibit metabolism of repaglinide
Increased risk of hypoglycemia
Concomitant use considered contraindication by Health Canada
www.wolterskluwercdi.com/clinical-notices/special-alerts/
DPP-4 Inhibitors and Joint Pain
New warning and precaution added to labels of all DPP-4 inhibitors
Based on FDA Adverse Event Reporting System database and medical literature
– 33 cases of severe arthralgia (10/16/2006 – 12/31/2013)
– All individuals had decreased level of activity
– 10 required hospitalization for disabling joint pain
Symptoms appeared within 1 day to years after starting medication; most resolved within 1 month of discontinuation
www.fda.gov/Drugs/DrugSafety/ucm459579.htm www.fda.gov/downloads/Drugs/DrugSafety/UCM460038.pdf
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 10
Canagliflozin and Bone Fractures
Increased bone fracture associated with canagliflozin
Mean exposure time: 85 weeks
Incidence per 100 patient-years of exposure: – 1.1 (placebo and active comparator)
– 1.4 (canagliflozin 100 mg)
– 1.5 (canagliflozin 300 mg)
Fractures seen as early as 12 weeks of therapy initiation
Mostly due to low trauma (falls from standing height)
Affected upper extremities
www.fda.gov/Drugs/DrugSafety/ucm461449.htm
Canagliflozin and Bone Mineral Density
Postmarketing safety trial: 714 older individuals with uncontrolled T2DM
– Duration: 2 years
– Bone mineral density (BMD) measured by dual-energy X-ray absorptiometry
Location Canagliflozin 100 mg* Canagliflozin 300 mg*
Total hip 0.9% 1.2%
Lumbar spine 0.3% 0.7%
Femoral neck 0.1% 0.1%
Distal forearm 0% 0.4%
* placebo-corrected decline in BMD
www.fda.gov/Drugs/DrugSafety/ucm461449.htm
Question of the Day
Based on the available information, should calcium supplementation be recommended to patients who are taking canagliflozin?
Yes No
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 11
SGLT2 Inhibitors and Euglycemic DKA
Warning based on 20 cases in the FDA Adverse Event Reporting System database from March 2013 – June 2014
No label change at this time
Factors identified as potential triggers:
– Infection
– Trauma
– Reduced food and fluid intake
– Reduced insulin dosage
www.fda.gov/Drugs/DrugSafety/ucm446845.htm
SGLT2-Induced Euglycemic Ketoacidosis
↑ urinary glucose
excretion
↑ urinary glucose
excretion
↓ plasma glucose levels
↓ plasma glucose levels
↓ plasma insulin levels
↓ plasma insulin levels
↑ glucagon, lipid oxidation,
and lipolysis
↑ glucagon, lipid oxidation,
and lipolysis
↑ mobilization of FFA and TG
↑ mobilization of FFA and TG
↑ ketogenesis and β-hydroxybutyrate
levels
↑ ketogenesis and β-hydroxybutyrate
levels
Worsened by ↓ insulin and ↓
CHO intake
Worsened by ↓ insulin and ↓
CHO intake
Euglycemic DKAEuglycemic DKA
Rosenstock J, et al. Diabetes Care. 2015;38:1638–42.
CARDIOVASCULAR OUTCOMES STUDIES
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 12
Newer Agents for Treatment of T2DM
SAVOR TIMI-53 and EXAMINE Trials
SAVOR TIMI-53 Trial– Hospitalization for heart failure statistically significant (SS) in saxagliptin arm
(3.5% vs 2.8%, HR 1.27, 95% CI 1.07–1.51, P=0.007)
EXAMINE Trial– Increased hospitalizations for heart failure in alogliptin arm; not SS
(3.9% vs 2.8%, HR 1.19, 95% CI 0.90–1.58, P=0.220)
1. Scirica BM, et al. N Engl J Med. 2013;369(14):1317-26.
2. Zannad F, et al. Lancet. 2015;385:2067- 76.
TECOS
14,671 patients from 673 sites in 38 countries
– Type 2 diabetes
– Established CV disease
– >50 years of age
– A1C level 6.5%–8.0%
Sitagliptin or placebo added to current therapy
Median follow-up: 3 years
Green JB, et al. N Engl J Med. 2015;373:232-42.
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 13
TECOS: Glycemic Control
A1C mean difference: -0.29% (95% CI, -0.32 to -0.27)
– Sitagliptin group received fewer additional antihyperglycemics (HR, 0.72; 95% CI, 0.68 to 0.77; P<0.001)
– Sitagliptin group less likely to start long-term insulin therapy (HR, 0.70; 95% CI, 0.63 to 0.79; P<0.001)
Green JB, et al. N Engl J Med. 2015;373:232-42.
TECOS: CV Outcomes
Primary composite CV outcome: first confirmed event of CV death, nonfatal MI, nonfatal stroke, or hospitalization for unstable angina –11.4% sitagliptin versus 11.6% placebo
– Non-inferiority: HR, 0.98; 95% CI, 0.88 to 1.09; P<0.001
– Superiority: HR, 0.98; 95% CI, 0.89 to 1.108; P=0.65
Secondary composite CV outcome: first confirmed event of CV death, nonfatal MI, or nonfatal stroke
– Non-inferiority: HR, 0.99; 95% CI, 0.89 to 1.11; P<0.001
– Superiority: HR, 0.99; 95% CI, 0.89 to 1.10; P=0.84
Green JB, et al. N Engl J Med. 2015;373:232-42.
TECOS: Heart Failure
Hospitalization for heart failure
– 3.1% sitagliptin and placebo groups (HR, 1.00; 95% CI, 0.83 to 1.20; P=0.98)
Composite outcome of hospitalization for heart failure or CV death
– 7.3% sitagliptin and 7.2% placebo (HR, 1.02; 95% CI, 0.90 to 1.15; P=0.74)
Green JB, et al. N Engl J Med. 2015;373:232-42.
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 14
FDA Advisory Panel Recommendations
Addition of a warning about potential risk for heart failure to:
Saxagliptin-containing products – Safe in general population
– Caution and additional monitoring in patients with eGFR <60 mL/min/1.73 m2 and prior history of heart failure
Alogliptin-containing products– Minor concern for heart failure
– Causal link difficult to establish
www..fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm453900.pdf
GLP-1 RA CV Safety Trials
LEADER: liraglutide
EXSCEL: exenatide
REWIND: dulaglutide
ELIXA: lixisenatide*
*New drug application (NDA) for lixisenatide accepted by FDA and awaiting review. Currently available in Europe, Japan, Australia, and Mexico.
ELIXA
6,068 patients from 49 countries– Type 2 diabetes diagnosis, acute coronary syndrome event within 70 days
– Mean duration of diabetes: 9 years
– Average A1C: 7.6%
– Mean BMI: 30 kg/m2
Lixisenatide or placebo added to current therapy
Study duration: 2 years
www.Medscape.com/viewarticle/846074
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 15
ELIXA
Primary composite outcome of CV death, nonfatal MI, nonfatal stroke, or hospitalization for unstable angina: no difference (1.02 HR; 95% CI, 0.89-1.17)
No difference between groups for secondary CV end points
www.Medscape.com/viewarticle/846074
EMPA-REG Outcome
7,020 patients from 590 sites in 42 countries
– Established CV disease
– A1C of 7–9% (no therapy) or 7–10% (stable therapy)
– BMI <45
– eGFR >30 mL/min/1.73 m2
Empagliflozin 10 mg, empagliflozin 25 mg, or placebo once daily added
Median study duration: 3.1 years
Zinman B, et al. N Engl J Med. 2015;373(22):2117–28.
EMPA-REG Outcome
Placebo (N=2333)
Empagliflozin(N=4687)
Hazard Ratio (95% CI)
P-Value NNT
Primary Outcome 282 (12.1%) 490 (10.5%) 0.86 (0.74-0.99) 62.5
Noninferiority <0.001
Inferiority 0.04
Secondary Outcome 333(14.3) 599 (12.8) 0.89 (0.78-1.01) 66.7
Noninferiority <0.001
Inferiority <0.08
Death
From any cause 194 (8.3) 269 (5.7) 0.68 (0.57-0.82) <0.001 38.5
From CV causes 137 (5.9) 172 (3.7) 0.62 (0.49-0.77) <0.001 45.5
Zinman B, et al. N Engl J Med. 2015;373(22):2117–28.
Noninferiority significance: <0.0249 Superiority significance: <0.0498
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 16
EMPA-REG Outcome
Individual CV outcome events were all non-significant, except:
– Hospitalization for heart failure
– Hospitalization for heart failure or death from CV causes (excluding fatal stroke)
Zinman B, et al. N Engl J Med. 2015;373(22):2117–28.
Placebo (N=2333)
Empagliflozin(N=4687)
Hazard Ratio (95% CI)
P-Value
Hospitalization for heart failure 95 (4.1) 126 (2.7)0.65
(0.50–0.85)0.002
Hospitalization for heart failure or death from CV causes excluding fatal stroke
198 (8.5) 265 (5.7)0.66
(0.55–0.79)<0.001
EMPA-REG Outcome
Adverse events favoring empagliflozin:
– Any adverse event (P<0.001)
– UTI in female patients (P<0.05)
– Acute kidney injury (P<0.05)
– Acute renal failure (P<0.01)
Adverse events favoring placebo:
– Male and female genital infections (P<0.001)
Zinman B, et al. N Engl J Med. 2015;373(22):2117–28.
EMPA-REG Outcome
If not an atherosclerotic benefit, then
HOW???
Benefit in patients without
established CV disease?
Is this a class effect?
What dose of empagliflozin
should be used?
Should empagliflozinbe a “go-to”
agent for patients with ↑ risk for heart
failure?
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 17
EMPA-REG Outcome – CKD Patients
Evaluated renal outcomes in patients with T2D and CKD:
– New-onset or worsening nephropathy
– Doubling of serum creatinine (+) eGFR <45 mL/min/1.73 m2
– Initiation of renal replacement therapy
– Death due to renal disease
Brunk D. Clinical Endocrinology News. 2015;10(12):12–15.Wanner C, et al. (Abstract HR-OR01). J Am Soc Nephrol. 2015;26:1133.
Outcome Effect Hazard Ratio
New-onset or worsening
nephropathy
39% decrease in empagliflozin
compared with placebo0.61; P<0.0001
Composite of doubling SCr,
renal replacement initiation,
death due to renal disease
46% decrease in empagliflozin
compared with placebo0.54; P=0.0002
EMPA-REG Outcome – CKD Patients
eGFR <60 eGFR >60
Primary outcome: 3
point major adverse
cardiac events
15% empagliflozin;
16% placebo (HR, 0.88)
9% empagliflozin;
11% placebo (HR, 0.84)
CV death6% empagliflozin;
8% placebo (HR, 0.78)
3% empagliflozin;
5% placebo (HR, 0.53)
Hospitalization for
heart failure
4% empagliflozin;
7% placebo (HR, 0.59)
2% empagliflozin;
3% placebo (HR, 0.70)
All-cause mortality9% empagliflozin;
12% placebo (HR, 0.80)
4% empagliflozin;
7% placebo (HR 0.62)
Brunk D. Clinical Endocrinology News. 2015;10(12):12–15.Wanner C, et al. (Abstract HR-OR01). J Am Soc Nephrol. 2015;26:1133.
Empagliflozin reduces CV morbidity and mortality in patients with T2D and various degrees of CKD
NEW AGENTS
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 18
Available Bolus Insulin Options
• Short acting: Regular (Novolin and Humulin R)
• Rapid acting:
• Aspart (NovoLog)
• Lispro (Humalog) **U-100 and U-200
• Glulisine (Apidra)
• Ultra-rapid acting: inhaled (Afrezza)
Lispro U-200
Similar efficacy to lispro U-100
Each 3-mL pen contains 600 units of insulin
No dose conversion between U-100 and U-200
U-100 U-200
Same units of insulin in half the volume of liquid
Fewer insulin pen device changes per week
uspl.lilly.com/humalog/humalog.html#pi
Basal Insulin Options
Intermediate acting: neutral protamine Hagedorn (Novolin and Humulin NPH)
Long acting:
– Detemir (Levemir)
– Glargine U-100 (Lantus)
– Glargine U-100 (Basaglar)
– Glargine U-300 (Toujeo)
– Degludec U-100 and U-200 (Tresiba)
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 19
“Follow-on” Insulin Glargine
Received tentative FDA approval in 2014 and final approval in 2015
– Abbreviated approval pathway
– Sufficiently similar to traditional insulin glargine U-100
Available in pen device for adult and pediatric patients with type 1 or type 2 diabetes
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm477734.htmhttps://investor.lilly.com/releasedetail.cfm?ReleaseID=947336
Glargine U-300
More concentrated: increased dose of insulin in less volume
Flatter and longer profile of action than glargine U-100
– Onset of action: 6 hours
– Maximum glucose lowering effect: up to 5 days
– Once-daily dosing
Less nocturnal hypoglycemia (compared with glargine U-100)
products.sanofi.us/toujeo/toujeo.pdf
Titrate every 5 days!
Glargine U-300
Higher dose of glargine U-300 needed than glargine U-100 to achieve same level of glycemic control
Glargine U-300 stable out of refrigerator for 42 days
products.sanofi.us/toujeo/toujeo.pdfLexicomp Online
Conversion Recommendation
Glargine U-100 to Glargine U-3001:1 conversion, but higher dose of
U-300 will be required
Glargine U-300 to Glargine U-100Use 80% of dose (20% dose
reduction) and adjust as needed
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 20
Degludec
Initiation:
• Type 1 (insulin naive): 0.2-0.4
units/kg/day –OR– ⅓ to ½ of total daily
dose (TDD)
• Type 2 (insulin naive): 10 units QD
General Dosing:
• Once daily any time of day
• Doses must be at least 8 hours apart
• No dose conversion between U-100 and
U-200
Titration: every 3-4 daysStable out of refrigerator up to
56 days (8 weeks)
www.novo-pi.com/tresiba.pdf
Basal Insulins
Onset Peak Duration
NPH 2-4 hours 6-10 hours 10-16 hours
Glargine U-100 5 hours NA 20-24 hours
Glargine U-300 6 hours NA 24-36 hours
Detemir 2 hours NA 6-24 hours
Degludec 1 hour NA >42 hours
Pre-Mixed Insulin
Insulin aspart/protamine (Novolog Mix)
Insulin lispro/protamine (Humalog Mix)
Insulin degludec/insulin aspart (Ryzodeg 70/30)
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 21
Insulin Degludec/Insulin Aspart
First combination of basal insulin with long duration of action
Once or twice daily dosing
Initiation– T1D (insulin naïve): 50% of total daily dose; give bolus at other meals– T2D (insulin naïve): 10 units once daily
– Conversion from pre-mixed or multiple daily injections: Divide total dose into 2 equal doses
– Once or twice daily basal insulin: unit to unit conversion and maintain dosing schedule
Storage: stable for 28 days out of refrigerator
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002499/WC500139011.pdfwww.accessdata.fda.gov/drugsatfda_docs/label/2015/203313lbl.pdf
Conclusions
The ADA and AACE/ACE differ on the management of diabetes.
DPP-4 inhibitors have been associated with joint pain. Use cautiously in pre-existing joint diseases.
Heart failure associated with DPP-4 inhibitors does not appear to be a class effect.
SGLT2 inhibitors have been associated with euglycemicketoacidosis.
Empagliflozin reduced CV morbidity and mortality in patients with T2DM and CVD.
Available U-200 insulin products are for volume only. No dose conversion needed!
Question 1SGLT2 inhibitors have been associated with:
A. Joint pain
B. Heart failure
C. Euglycemic DKA
D. Worsening albuminuria
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 22
Question 2In which disease state should DPP-4 inhibitor treatment be used cautiously?
A. Mild renal impairment
B. Rheumatoid arthritis
C. Recurrent UTI
D. Osteoporosis
Question 3Which was a finding of the treatment arm in the EMPA-REG Outcome Study?
A. Increased incidence of diabetic ketoacidosis
B. Increased incidence of bone fractures
C. Decreased incidence of genital infections
D. Decreased incidence of CV death
Questions?
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 23
Attendance Code and Claiming Credit
DM16To obtain CPE credit for participating in this live webinar:
1. Go to:
http://elearning.pharmacist.com/products/4515/diabetes-care-update-2016-live-2-25-16
2. Login using your APhA username and password
3. Click “Enroll Now” button to begin the assessment and evaluation
4. Once you have successfully completed the assessment and evaluation, you may then claim credit. You must claim credit for attending the live webinar by March 25, 2016.
© 2016 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 24
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