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Tresiba- insulin degludec
Manufacturer: Novo Nordisk
FDA Approval Date: 9/25/2015
Tresiba® - insulin degludec
Objectives
• At the end of this presentation participants will be able to:1. Appropriately recommend Tresiba®-
insulin degludec
2. Effectively educate patients on the purpose, proper use and potential adverse effects of Tresiba®- insulin degludec
Tresiba® - insulin degludec
Clinical Application
• Indications: • Glycemic control in diabetes
• Types I and II
• Place in therapy:• Similar to that of Lantus or Levemir
• Long-acting basal insulin
Tresiba® [package insert].
Tresiba® - insulin degludec
Clinical Application
• Contraindications:• Hypersensitivity to insulin products
• Use in DKA
• Use during hypoglycemia
• Warnings/precautions:• Hypoglycemia
• Hypokalemia
Tresiba® [package insert].
Tresiba® - insulin degludec
Clinical Application
• Pregnancy:• Category C
• No studies in pregnant women• Weigh risk/benefit of using during pregnancy
• Lactation:• Unknown if excreted in breastmilk
• Endogenous insulin is excreted in breastmilk, so mothers may require adjustments in insulin or meal plan when breastfeeding
Tresiba®[package insert].
Tresiba® - insulin degludec
Drug Facts
• Pharmacology:• Insulin is an endogenous peptide
hormone
• Stimulates cellular glucose uptake and utilization
• Insulin degludec arranges into hexamers after subcutaneous injection that allow it to form a depot
Tresiba®[package insert].
Tresiba® - insulin degludec
Drug Facts
• Pharmacokinetics:
A Tmax ~ 9 hours
D Protein binding >99%
M No clinically relevant Hepatic/Renal metabolism, cleared by uptake into cells
E T ½: 25hrs, duration of action: 42hrs
Tresiba®[package insert].
Tresiba® - insulin degludec
Drug Interactions
• No direct drug-drug interactions
• Consider drugs which may alter blood glucose levels or mask/blunt symptoms of hypoglycemia• Sulfonylureas, SGLT2s
• Corticosteroids, thiazide diuretics
• β-blockers, clonidine
Tresiba®[package insert].
Tresiba® - insulin degludec
Adverse Effects
*over 1 year of treatmentTresiba -insulin
degludec
Lantus-insulin
glargine
Hypoglycemia 81% 82%
Nasopharyngitis 14% 14%
Upper respiratory tract infection 14% 13%
Headache 9% 7%
Arthralgia 4% 8%
Diarrhea 6% 8%
Tresiba®[package insert].
Tresiba® - insulin degludec
Monitoring Parameters
• Efficacy Monitoring:• Blood glucose- daily (fasting, meals)
• A1c- every 3 months
• Toxicity Monitoring:• Blood glucose
Tresiba®[package insert].
Tresiba® - insulin degludec
Prescription Information
• Dosing: • T1DM: ⅓- ½ daily insulin requirement, given
once daily (generally daily requirement is 0.2-0.4 Units/kg in insulin-naïve patients
• T2DM: Starting dose ~ 10 units once daily
• Cost: pricing not determined, will be available Q1 2016 as a 3mL Flextouch pen.
Tresiba®[package insert].
Tresiba® - insulin degludec
Literature Review
BEGIN Basal-bolus Type II
•Purpose: compare insulin degludec to insulin glargine in efficacy and adverse effect profile
•Design: Phase III, randomized, open-label, treat-to-target trial
Garber A, et al. Lancet. 2012; 379:1498–507.
Tresiba® - insulin degludec
Literature Review
• Primary endpoint: change from baseline in HbA1c concentration after 52 weeks
• Secondary endpoints: change in fasting plasma glucose from baseline, percentage of patients reaching A1c goal of <7%
• Safety assessment: hypoglycemia
Garber A, et al. Lancet. 2012; 379:1498–507.
Tresiba® - insulin degludec
Literature Review
• Included: Type II diabetics, age >18, diagnosed >6 months, HbA1c 7.0-10.0 with current insulin treatment for at least 3 months
• Excluded: Use of GLP-1 or rosiglitazone in last 3 months, CV event within previous 6 months, uncontrolled HTN, pregnancy, impaired renal/hepatic function
Garber A, et al. Lancet. 2012; 379:1498–507.
Tresiba® - insulin degludec
Literature Review
• Background:Tresiba –
insulin degludec n=744
Lantus – insulin glargine
n=248
Sex, male 405 (54%) 133 (54%)
Race, white 83% 82%
Age (years) 59.2 (9.1) 58.1 (10.0)
A1c 8.3% (0.8) 8.4% (0.9)
Duration of diabetes 13.6 (7.4) 13.4% (6.9)
Garber A, et al. Lancet. 2012; 379:1498–507.
Tresiba® - insulin degludec
Literature Review
• Intervention: randomize patients (N=1006) at a 3:1 ratio of insulin degludec:insulin glargine once daily
• Insulin doses were titrated until patient-reported fasting blood sugars on 3 days previous to appointment averaged 70mg/dL-90mg/dL.
• Patients continued for 52 weeks
Garber A, et al. Lancet. 2012; 379:1498–507.
Tresiba® - insulin degludec
Literature Review
• Results:
Tresiba – insulin
degludec
Lantus – insulin
glargine Mean A1c decrease
1.10% 1.18% Difference of 0.08 (95%CI -0.05 to 0.21)
Mean decrease in fasting BG
41.4 mg/dl 36.0 mg/dL Difference of -0.29 (95%CI -0.65 to 0.06)
Patients reaching A1c <7%
368 (49%) 124 (50%)
Garber A, et al. Lancet. 2012; 379:1498–507.
Tresiba® - insulin degludec
Literature Review
• Safety Outcome: Hypoglycemia
Tresiba – insulin degludec
Lantus – insulin glargine
Severe 34 (5%) 11 (4%)
Overall 609 (81%) 206 (82%)
Nocturnal 298 (40%) 119 (47%)
Garber A, et al. Lancet. 2012; 379:1498–507.
Tresiba® - insulin degludec
Literature Review
Safety outcome: hypoglycemia (individual episodes)
Tresiba – insulin
degludec
Lantus – insulin
glargine
Rate ratio insulin degludec: insulin glargine (95% CI)
P-value
Severe (rate per PYE)
41 (0.06) 12 (0.05) N/A N/A
Overall (rate per PYE)
7437 (11.09) 3120 (13.63) 0.82 (0.69-0.99) 0.0359
Nocturnal (rate per PYE)
930 (1.39) 422 (1.84) 0.75 (0.58-0.99) 0.0359
Garber A, et al. Lancet. 2012; 379:1498–507.
Tresiba® - insulin degludec
Literature Review
BEGIN Basal-bolus Type II
•Conclusion: Insulin degludec is non-inferior to insulin glargine in HbA1c lowering
•May have benefit of reduced rates of nocturnal hypoglycemia and hypoglycemia overall
Garber A, et al. Lancet. 2012; 379:1498–507.
Tresiba® - insulin degludec
Summary• Tresiba, insulin degludec, is a new long-acting insulin
similar in administration and dosing to Levemir and Lantus. Insulin degludec forms hexamers after injection.
• Suggested monitoring with home glucose and A1c are similar to other diabetes agents
• Hypoglycemia, injection site reactions, and weight gain are similar to other insulins
• Does not have any true drug-drug interactions, caution use with agents which may further lower glucose, offset glucose lowering effect, or mask Sx hypoglycemia
• Isulin degludec will be available in early 2016 in 3mL “Flextouch” pens
Tresiba® - insulin degludec
References
1. Tresiba [package insert]. Bagsvaerd, Denmark: Novo Nordisk; 2015.
2. Garber A, King A et al. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes. Lancet. 2012; 379:1498–507.