A TREATMENT FOR ADULTS WITH TYPE 2 DIABETES MELLITUS, IN ADDITION TO DIET AND EXERCISE
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PERCENTAGE OF PATIENTS
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IN MONOTHERAPY AND ADD-ON THERAPY STUDIESa | ONGLYZA 5 mg | Placebo |
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Upper Respiratory Tract Infection | 7.7% | 7.6% |
Urinary Tract Infection | 6.8% | 6.1% |
Headache | 6.5% | 5.9% |
(n=882) | (n=799) |
aThe 5 placebo-controlled trials include 2 monotherapy trials and 1 add-on combination therapy trial with each of the following: metformin, thiazolidinedione, or glyburide. Table shows 24-week data regardless of glycemic rescue.
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PERCENTAGE OF PATIENTS
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ONGLYZA 5 mg | ONGLYZA 2.5 mg | Placebo | |
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Lymphopenia | 0.5% | 0.1% | 0.0% |
Rash | 0.3% | 0.2% | 0.3% |
Blood Creatinine Increase | 0.0% | 0.3% | 0.0% |
Blood Creatine Phosphokinase Increase | 0.2% | 0.1% | 0.0% |
bPrespecified pooled analysis of 2 monotherapy studies, add-on to metformin IR (vs metformin IR + placebo) study, the add-on to the SU glyburide (vs glyburide + placebo) study, and the add-on to a TZD (vs TZD + placebo) study; 24-week data regardless of glycemic rescue.
cReported in at least 2 patients treated with ONGLYZA.
*Prespecified pooled analysis of 3 monotherapy studies, the add-on to metformin IR (vs metformin IR + placebo) study, the add-on to the SU glyburide (vs glyburide + placebo) study, and the add-on to a TZD (vs TZD + placebo) study; 24-week data regardless of glycemic rescue.1
Confirmed hypoglycemia is defined by symptoms of hypoglycemia in the setting of a fingerstick blood glucose value <50 mg/dL. Reported hypoglycemic events were a combination of reports of either signs or symptoms consistent with hypoglycemia with or without documented glucose levels or reported low glucose levels without any symptoms. A concurrent glucose measurement was not required or was normal in some patients. Therefore, it is not possible to conclusively determine that all these reports reflected true hypoglycemia.
ONGLYZA is weight neutral1
ONGLYZA is not indicated for weight loss.
REPORTED HYPOGLYCEMIAd | ONGLYZA 5 mg | ONGLYZA 2.5 mg | Comparator |
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Add-on to Metformin IR | 5.8% | 7.8% | 5.0% |
Initial Combination With Metformin IR | 3.4% | — | 4.0% |
Add-on to Glyburide | 14.6% | 13.3% | 10.1% |
Add-on to a TZD | 2.7% | 4.1% | 3.8% |
Combination With Insuline | 18.4% | — | 19.9% |
Add-on to Metformin + Sulfonylurea | 10.1% | — | 6.3% |
Pooled Monotherapy (2 studies) | 5.6% | 4.0% | 4.1% |
CONFIRMED HYPOGLYCEMIAf | ONGLYZA 5 mg | ONGLYZA 2.5 mg | Comparator |
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Add-on to Glyburide | 0.8% | 2.4% | 0.7% |
Combination With Insuline | 5.3% | — | 3.3% |
Add-on to Metformin + Sulfonylurea | 1.6% | — | 0.0% |
dReported hypoglycemia events were a combination of reports of either signs or symptoms consistent with hypoglycemia with or without documented glucose levels or reported low glucose levels without any symptoms.
eWith or without metformin IR.
fDefined as symptoms of hypoglycemia accompanied by a fingerstick glucose ≤50 mg/dL.
ONGLYZA 2.5 mg was compared with placebo in a 12-week trial in 170 patients with type 2 diabetes and moderate or severe renal impairment or ESRD on hemodialysis. The incidence of adverse reactions, including serious adverse reactions and discontinuations due to adverse reactions, was similar between ONGLYZA and placebo.1,3
Adverse event summary during 12-week treatment period3,g
AEs, n (%)h | ONGLYZA 2.5 mg | Placebo |
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≥1 AE | 49 (57.6) | 46 (54.1) |
≥1 Treatment-Related AE | 9 (10.6) | 6 (7.1) |
Discontinuation Due to AEs | 5 (5.9) | 1 (1.2) |
≥1 SAE | 12 (14.1) | 7 (8.2) |
≥1 Treatment-Related SAE | 1 (1.2) | 1 (1.2) |
Discontinuation Due to SAE | 3 (3.5) | 1 (1.2) |
Deaths | 0 (0) | 0 (0) |
Most Common AEs (≥3%), n (%)i | ||
Urinary Tract Infection | 4 (4.7) | 2 (2.4) |
Hypertension | 3 (3.5) | 4 (4.7) |
Diarrhea | 3 (3.5) | 0 (0) |
Hyperglycemia | 3 (3.5) | 0 (0) |
Anemia | 1 (1.2) | 4 (4.7) |
Dyspepsia | 0 (0) | 3 (3.5) |
(n=85) | (n=85) |
gSafety analysis set.
hIncludes hypoglycemic events.
iExcludes hypoglycemic events.