Superior A1C reductions vs each individual component
MEAN A1C REDUCTIONS OVER 24 WEEKS (COMPLETERS)1
Mean A1C achieved: 6.7% and 6.9%
Uncontrolled on metformin*
Mean baseline: 7.9% and 8.0%
- GLYXAMBI 10/5 mg
- GLYXAMBI 25/5 mg
- SGLT2i (empagliflozin 10 mg)
- SGLT2i (empagliflozin 25 mg)
- DPP-4i (linagliptin 5 mg)
- *1889 mg/day mean dose metformin.1
- †ADA recommends an A1C target of <7%. Individual goal of patient should be determined by their physician.
- Change from baseline vs individual components, p<0.0001.1
- DPP-4i=dipeptidyl peptidase-4 inhibitor; SGLT2i=sodium glucose co-transporter-2 inhibitor.
Individual component mean A1C achieved from the completer analysis: 7.3% for linagliptin 5 mg, 7.3% for empagliflozin 10 mg, 7.3% for empagliflozin 25 mg.1
In the modified intent-to-treat analysis of the primary endpoint, the adjusted mean A1C change from baseline for GLYXAMBI 10/5 mg was -1.1% (n=135); GLYXAMBI 25/5 mg, -1.2% (n=133); linagliptin 5 mg, -0.7% (n=128); empagliflozin 10 mg, -0.7% (n=137); empagliflozin 25 mg, -0.6% (n=139). GLYXAMBI vs individual components, p<0.0001.1
Mean A1C change in patients with baseline ≥8.5% (subgroup analysis)*
A1C CHANGE FROM A MEAN BASELINE OF 9.1% AT WEEK 242
- GLYXAMBI 10/5 mg (n=30, mean baseline: 9.1%)
- GLYXAMBI 25/5 mg (n=32, mean baseline: 9.1%)
- SGLT2i (empagliflozin 10 mg) (n=35, mean baseline: 9.3%)
- SGLT2i (empagliflozin 25 mg) (n=36, mean baseline: 9.2%)
- DPP-4i (linagliptin 5 mg) (n=33, mean baseline: 9.3%) = -1.0%
- *Exploratory endpoint; ≥8.5% baseline stratified at randomization.2
~2x more patients achieved A1C goal of <7% with GLYXAMBI vs each individual component
PERCENT OF PATIENTS WHO ACHIEVED GOAL AT WEEK 24
- GLYXAMBI Average 10/5 mg and 25/5 mg (n=251)
SGLT2i: empagliflozin 10 mg and 25 mg
DPP-4i: linagliptin 5 mg (n=376)
Average baseline A1C: 8.0%
- 58% for GLYXAMBI 10/5 mg (n=128) and 62% for GLYXAMBI 25/5 mg (n=123), respectively.
- 36% for linagliptin 5 mg (n=119), 28% for empagliflozin 10 mg (n=125), and 33% for empagliflozin 25 mg (n=132), respectively.
In addition to lowering A1C, GLYXAMBI reduced weight²*
*GLYXAMBI is not indicated for weight loss. Weight change from baseline vs linagliptin was a secondary endpoint.
MEAN WEIGHT LOSS AT WEEK 24
p<0.0001 vs linagliptin.
- GLYXAMBI 10/5 mg 191 lb (n=135)
- GLYXAMBI 25/5 mg 187 lb (n=134)
- SGLT2i (empagliflozin 10 mg) 189 lb (n=137)
- SGLT2i (empagliflozin 25 mg) 194 lb (n=140)
- DPP-4i (linagliptin 5 mg) 187 lb (n=128)
Demonstrated safety profile evaluated over 52 weeks
Incidence of overall* and severe† hypoglycemic events—through Week 52 in patients uncontrolled on metformin
OF SEVERE HYPOGLYCEMIA WERE REPORTED
|Urinary tract infection (UTI)‡||12.5%||11.4%|
|Upper respiratory tract infection||7.0%||7.0%|
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.
A once-daily pill with 2 dosage strengths
5 mg linagliptin 10/5 mg
5 mg linagliptin 25/5 mg
GLYXAMBI may be taken with or without food
Assessment of renal function is recommended prior to initiation of GLYXAMBI
DOSING AND ADMINISTRATION INFORMATION
Dosing guidance in patients with renal impairment
Additional Dosing Guidance
- In patients with volume depletion, correcting this condition prior to initiation of GLYXAMBI is recommended
- GLYXAMBI is contraindicated in patients with severe renal impairment, end-stage renal disease, or dialysis; a history of hypersensitivity reaction to empagliflozin, linagliptin, or any of the excipients in GLYXAMBI such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity
- A lower dose of insulin or insulin secretagogues (eg, SUs) may be required to reduce the risk of hypoglycemia when used in combination with GLYXAMBI
- No studies have been performed specifically examining the safety and efficacy of GLYXAMBI in patients previously treated with other oral antihyperglycemic agents and switched to GLYXAMBI