1. 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
This speaker has no actual or potential conflicts of interest to disclose in relation to this presentation

2. 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

3. 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 National Diabetes Statistics Report;2014.

4. Toujeo® Mechanism of Action Indications
Regulation of glucose metabolism
Prolonged release of insulin compared to that of insulin glargine (U-100)
Indications
Improve 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.

5. Dosing Insulin Naïve Patients Starting Dose of Toujeo® Frequency
Type 1 DM
units/kg/day
Once Daily
Type 2 DM
0.2 units/kg/day
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%
Toujeo® (package insert).Sanofi-Aventis U.S. LLC; 2015.

6. **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

7. Pharmacokinetics Property Toujeo® Lantus® Onset (hours) 6 4-5
Duration of Action (hours)
24-36 24
Time to Steady State
5 days
24 hours
Toujeo® (package insert).Sanofi-Aventis U.S. LLC; 2015.
Lantus® (package insert).Sanofi-Aventis U.S. LLC;2015.

8. 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.

9. Clinical Data Type 1 DM 26 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.

10. Clinical Data Type 2 DM 26 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.

11. Conclusions Toujeo® is a concentrated formulation of insulin glargine
300 units/ml
Trials suggest Toujeo® is as effective as glargine in ↓ A1c
↑ Toujeo® dosages may be needed to maintain similar glycemic control

12. 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