SAFETY
FOR ADULTS WITH TYPE 2 DIABETES
Demonstrated safety profile evaluated over 52 weeks
Incidence of overall* and severe† hypoglycemic events–through Week 52 in patients uncontrolled on metformin
| Add-on to metformin | ||
|---|---|---|
| GLYXAMBI 10/5 mg (N=136) | GLYXAMBI 25/5 mg (N=137) | |
| Overall (%) | 2.2% | 3.6% | 
| Severe (%) | 0% | 0% | 
No cases of severe hypoglycemia were reported
| Adverse reactions reported in ≥5% of patients on GLYXAMBI | ||
|---|---|---|
| GLYXAMBI 10/5 mg (N=272) | GLYXAMBI 25/5 mg (N=273) | |
| Urinary tract infection (UTI)‡ | 12.5% | 11.4% | 
| Nasopharyngitis | 5.9% | 6.6% | 
| Upper respiratory tract infection | 7.0% | 7.0% | 
0 patients discontinued due to these most common adverse reactions
- * Overall hypoglycemic events: plasma or capillary glucose ≤70 mg/dL or requiring assistance.
- † Severe hypoglycemic events: requiring assistance regardless of blood glucose.
- ‡ Predefined adverse event grouping, including, but not limited to, UTI, asymptomatic bacteriuria, and cystitis.
Reference
- DeFronzo RA, Lewin A, Patel S, et al. Combination of empagliflozin and linagliptin as second-line therapy in subjects with type 2 diabetes inadequately controlled on metformin. Diabetes Care. 2015;38(3):384-393.


 
  
  
  
 
