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.