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A TREATMENT FOR ADULTS WITH TYPE 2 DIABETES MELLITUS, IN ADDITION TO DIET AND EXERCISE

SAFETY PROFILE

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DEMONSTRATED SAFETY PROFILE ACROSS MULTIPLE STUDIES AND DIVERSE POPULATIONS1

Adverse reactions in placebo-controlled trials reported in ≥5% of patients1,a

IN MONOTHERAPY AND ADD-ON THERAPY STUDIESa

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PERCENTAGE OF PATIENTS
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IN MONOTHERAPY AND ADD-ON THERAPY STUDIESa ONGLYZA 5 mg Placebo
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.

  • In patients treated with ONGLYZA 2.5 mg, headache (6.5%) was the only adverse reaction reported at a rate ≥5% and more commonly than in patients treated with placebo1
  • The overall proportion of patients who discontinued due to an adverse event was 2.2% with ONGLYZA 2.5 mg, 3.3% with ONGLYZA 5 mg, and 1.8% with placebo
  • There was a dose-related mean decrease in absolute lymphocyte count observed with ONGLYZA1

 

DISCONTINUATION OF THERAPY DUE TO ADVERSE REACTIONS1

Most common adverse events associated with discontinuation of therapy1,b,c

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PERCENTAGE OF PATIENTS
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  ONGLYZA 5 mg ONGLYZA 2.5 mg Placebo
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.

  • Hypersensitivity-related events (eg, urticaria, facial edema) were reported in 1.5%, 1.5%, and 0.4% of patients who received ONGLYZA 5 mg, ONGLYZA 2.5 mg, and placebo, respectively1,*
  • In the clinical trial database for saxagliptin to date, there have been 6 reports (0.12%) of tuberculosis among the patients treated with saxagliptin compared with no reports among the patients treated with the comparator. Causality has not been established.1 In addition, 1 patient treated with saxagliptin developed suspected foodborne fatal salmonella sepsis. There have been no spontaneous reports of tuberculosis or opportunistic infections associated with saxagliptin use1
  • There was a dose-related mean decrease in absolute lymphocyte count observed with ONGLYZA1,*

*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

 

LOW RATES OF HYPOGLYCEMIA OVER 24 WEEKS WHEN ADDED TO METFORMIN1,2

  • The confirmed incidence of hypoglycemia with ONGLYZA 2.5 mg and ONGLYZA 5 mg vs placebo were 0.5% and 0.5% vs 0.6%, respectively
  • The reported incidence of hypoglycemia with ONGLYZA 2.5 mg and ONGLYZA 5 mg vs placebo was 7.8% and 5.8% vs 5%, respectively

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 neutral

ONGLYZA is not indicated for weight loss.

 

INCIDENCE OF HYPOGLYCEMIA OVER 6 MONTHS (% OF PATIENTS) IN POOLED RESULTS1

REPORTED HYPOGLYCEMIAd ONGLYZA 5 mg ONGLYZA 2.5 mg Comparator
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
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.

 


SIMILAR INCIDENCE OF ADVERSE REACTIONS IN A 12-WEEK STUDY IN PATIENTS WITH RENAL IMPAIRMENT1

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
≥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.