toujeo ® and it’s place in therapy sharmon p. osae, pharmd richard l. roudebush va medical center...
TRANSCRIPT
Toujeo® and it’s Place in TherapySharmon P. Osae, PharmD
Richard L. Roudebush VA Medical Center / Purdue University
PGY-2 Ambulatory Care / Education Resident
September 17, 2015
This speaker has no actual or potential conflicts of interest to disclose in relation to this presentation
Objectives
At the end of this presentation, the participants will be able to:
Describe the national burden of diabetes on the United States
Compare and contrast insulin glargine formulations and identify recommendations regarding their use
Provide evidence-based recommendations regarding the use of Toujeo in patients with diabetes
Epidemiology
Estimated 29.1 million Americans living with diabetes mellitus (DM) Approximately 1.25 million with Type 1 DM
86 million Americans ≥20 years old with pre-diabetes
DM is the 7th leading cause of death in the United states
Centers for Disease Control and Prevention. 2014 National Diabetes Statistics Report;2014.
Toujeo®
Mechanism of ActionRegulation of glucose metabolism
Prolonged release of insulin compared to that of insulin glargine (U-100)
IndicationsImprove glycemic control in adults with type 1 and
type 2 DM
• 300 units/ml
• 1.5 ml pen
Toujeo® (package insert).Sanofi-Aventis U.S. LLC; 2015.
Dosing
Insulin Naïve Patients
Starting Dose of Toujeo® Frequency
Type 1 DM 0.2-0.4 units/kg/day Once Daily
Type 2 DM 0.2 units/kg/day Once Daily
Insulin Experienced Patients - Conversions
Insulin Conversion Frequency
Once daily long acting (U-100) to Toujeo®
1:1** Once Daily
Twice daily NPH to Toujeo®
Decrease total daily dose of NPH
by 20%
Once Daily
Toujeo® (package insert).Sanofi-Aventis U.S. LLC; 2015.
**Caveat**For patients maintained on Lantus® insulin glargine (U-100),
expect a higher daily dose requirement of Toujeo® to maintain the same level of glycemic control
Pharmacokinetics
Toujeo® (package insert).Sanofi-Aventis U.S. LLC; 2015.Lantus® (package insert).Sanofi-Aventis U.S. LLC;2015.
Property Toujeo® Lantus®
Onset (hours) 6 4-5
Duration of Action (hours) 24-36 24
Time to Steady State 5 days 24 hours
Adverse Effects
No difference between U-100 insulin
Hypoglycemia
Weight gain
Lipodystrophy
Hypokalemia
Injection site reactions
Toujeo® (package insert).Sanofi-Aventis U.S. LLC; 2015.
Clinical Data
Type 1 DM26 week open-label randomized controlled trial
Intervention• Toujeo ® once daily + bolus insulin with meals (n=273)
• Lantus ® once daily + bolus insulin with meals (n=273)
Results• Toujeo arm average A1c reduction of 0.4%
• Lantus arm average A1c reduction 0.44%
• Toujeo arm utilized 17.5% more basal insulin
• No differences in body weight
Toujeo® (package insert).Sanofi-Aventis U.S. LLC; 2015.Home PD et al. European Association for the Study of Diabetes Congress 2014, abstract 148.
Clinical Data
Type 2 DM26 week open-label randomized controlled study
Intervention• Toujeo once daily + bolus insulin +/- metformin (n=404)
• Lantus once daily + bolus insulin +/- metformin (n=400)
Results• Toujeo arm average A1c reduction of 0.9%
• Lantus arm average A1c reduction 0.87%
• Toujeo arm utilized 11% more basal insulin
• No differences in body weight
Toujeo® (package insert).Sanofi-Aventis U.S. LLC; 2015.Ritzel RA et al. European Association for the Study of Diabetes congress, 2014, abstract 963.
Conclusions
Toujeo® is a concentrated formulation of insulin glargine300 units/ml
Trials suggest Toujeo® is as effective as glargine in ↓ A1c ↑ Toujeo® dosages may be needed
to maintain similar glycemic control
Toujeo® and it’s Place in Therapy
Sharmon P. Osae, PharmD
Richard L. Roudebush VA Medical Center / Purdue University
PGY-2 Ambulatory Care / Education Resident
September 17, 2015