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

ONGLYZA AS ADD-ON THERAPY

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A1C Reductions

FPG-PPG Reductions

Study Design

MEANINGFUL A1C REDUCTIONS WHEN PATIENTS WERE UNCONTROLLED ON METFORMIN^1,2

Significant difference in mean A1C reductions vs placebo at 24 weeks^1,2,a,b

Mean change from baseline (%)

A1C reductions reported- ONGLYZA 5 mg + metformin IR= -0.7% vs placebo +metformin IR=+0.1%

MEAN DIFFERENCE IN A1C CHANGES FROM PLACEBO

0.8%

MEAN DIFFERENCE IN A1C CHANGES FROM PLACEBO

P<0.0001.

^aMean baseline A1C level was 8.1% for all groups.

^bAdjusted mean change in A1C level from baseline.

Intent-to-treat population using last observation on study prior to pioglitazone rescue therapy for patients needing rescue.

Significant difference in mean A1C reductions with ONGLYZA 2.5 mg + metformin (n=186) vs placebo + metformin (n=175) at 24 weeks (-0.6% vs 0.1%, respectively; 0.7% difference from placebo; P<0.0001)^1,2,*^,†
“Uncontrolled” defined as A1C ≥7.0% and ≤10%
The proportion of patients who discontinued for lack of glycemic control or who were rescued for meeting prespecified glycemic criteria was 15% in the ONGLYZA 2.5 mg + metformin group, 13% in the ONGLYZA 5 mg + metformin group, and 27% in the placebo + metformin group

*Mean baseline A1C level was 8.1% for all groups.

^†Adjusted mean change in A1C level from baseline.

SIGNIFICANTLY REDUCED FPG AND PPG AT 6 MONTHS^1,2

ONGLYZA added to metformin IR delivered statistically significant reductions in fasting plasma glucose (FPG) and postprandial glucose (PPG) vs placebo + metformin IR at 6 months^1,2,c

Mean change from baseline(mg/dL)

Reductions with ONGLYZA 5 mg + metformin IR= -22mg/dl vs placebo + metformin IR=+1mg/dl and 2hrs PPG- ONGLYZA 5mg + metformin IR= -22mg/dl vs placebo + metformin IR= -18mg/dl

MEAN DIFFERENCE IN FPG AND PPG CHANGES FROM PLACEBO

-23 mg/dL

(95% Cl: -30 mg/dL, -16 mg/dL)

MEAN DIFFERENCE IN FPG AND PPG CHANGES FROM PLACEBO

-23 mg/dL

(95% Cl: -30 mg/dL, -16 mg/dL)

-40 mg/dL

(95% Cl: -56 mg/dL, -24 mg/dL)

MEAN DIFFERENCE IN FPG AND PPG CHANGES FROM PLACEBO

-23 mg/dL

(95% Cl: -30 mg/dL, -16 mg/dL)

-40 mg/dL

(95% Cl: -56 mg/dL, -24 mg/dL)

P<0.05 vs placebo + metformin IR.

^cIntent-to-treat population using last observation on study prior to pioglitazone rescue therapy.

Reductions with ONGLYZA 2.5 mg + metformin IR were: FPG, -14 mg/dL (n=188; baseline FPG, 174 mg/dL) and PPG, -62 mg/dL (n=155; baseline PPG, 294 mg/dL) vs placebo + metformin IR at 6 months^1,2

Hypoglycemia: When ONGLYZA was used in combination with a sulfonylurea or with insulin, the incidence of confirmed hypoglycemia was increased over that of placebo. Consider lowering the dose of these agents when coadministered with ONGLYZA.

STUDY DESIGN^1,2

ONGLYZA as Add-On Therapy

Phase 3, 24-week, multicenter, randomized, double-blind, placebo-controlled study

*Metformin IR dose was between 1500 and 2500 mg daily.

Study Objective

Evaluate the efficacy and safety of ONGLYZA in addition to diet and exercise as add-on to metformin IR compared to placebo + metformin IR.

Primary Efficacy End Point

A1C change from baseline at 6 months

Secondary and Other Efficacy End Points

FPG change from baseline at 6 months
Percentage of patients achieving A1C <7.0%
PPG change from baseline following an oral glucose tolerance test at 6 months

Study Length

6 months

Key Inclusion Criteria

Demographic: Men and women age 18–77 years

Diagnosis: T2DM

A1C: ≥7.0% and ≤10.0%

Metformin Dose: Stable monotherapy ≥1500 mg/day but not >2550 mg/day for at least 8 weeks prior to enrollment

Fasting C-peptide: ≥1.0 ng/mL

Body Mass Index: ≤40 kg/m²

Study Dosing

After the lead-in period, eligible patients were randomly assigned 5 mg saxagliptin or placebo for 24 weeks in addition to their lead-in dose of open-label metformin.

Primary Efficacy End Point

A1C change from baseline at 6 months

Secondary and Other Efficacy End Points

FPG change from baseline at 6 months
Percentage of patients achieving A1C <7.0%
PPG change from baseline following an oral glucose tolerance test at 6 months

IMPORTANT SAFETY INFORMATION

Important Safety Information for ONGLYZA

Contraindications

Prior serious hypersensitivity reaction to ONGLYZA

Warnings and Precautions

Pancreatitis: There have been postmarketing reports of acute pancreatitis in patients taking ONGLYZA, and in the SAVOR cardiovascular outcomes trial. Observe for pancreatitis. If pancreatitis is suspected, discontinue ONGLYZA.

Heart Failure: In the SAVOR cardiovascular outcomes trial, more patients treated with ONGLYZA were hospitalized for heart failure compared to placebo. Patients with a prior history of heart failure or renal impairment had a higher risk for hospitalization for heart failure. Consider the risks and benefits of ONGLYZA in patients who have known risk factors for heart failure. Monitor for signs and symptoms. If heart failure develops, consider discontinuation of ONGLYZA.

Hypersensitivity Reactions: Serious reactions have been reported in patients treated with ONGLYZA, including anaphylaxis, angioedema, and exfoliative skin conditions. Onset of these reactions occurred within the first 3 months after initiation of treatment with ONGLYZA, with some reports occurring after the first dose. If a serious hypersensitivity reaction is suspected, discontinue ONGLYZA. Use caution in patients with a history of angioedema to another DPP-4 inhibitor.

Severe and Disabling Arthralgia has been reported in patients taking DPP-4 inhibitors. The time to onset of symptoms following initiation of drug therapy varied from one day to years. Patients experienced relief of symptoms upon discontinuation. A subset of patients experienced a recurrence of symptoms when restarting the same drug or a different DPP-4 inhibitor. Consider discontinuing drug if appropriate.

Bullous Pemphigoid: There have been postmarketing reports of bullous pemphigoid requiring hospitalization in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If suspected, discontinue ONGLYZA.

Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with ONGLYZA.

Most Common Adverse Reactions

Most common adverse reactions reported in ≥5% of patients treated with ONGLYZA and more commonly than in patients treated with placebo were upper respiratory tract infection (7.7%, 7.6%), urinary tract infection (6.8%, 6.1%), and headache (6.5%, 5.9%).

Peripheral edema was reported more commonly in patients treated with the combination of ONGLYZA 5 mg and a thiazolidinedione (TZD) than in patients treated with the combination of placebo and TZD (8.1% vs 4.3%, respectively).

Drug Interactions

Strong CYP3A4/5 inhibitors (eg, ketoconazole): Coadministration with ONGLYZA significantly increases saxagliptin concentrations. Recommend limiting ONGLYZA dosage to 2.5 mg once daily.

Use in Specific Populations

In patients with moderate or severe renal impairment, or end-stage renal disease (eGFR <45 mL/min/1.73 m²), recommended dosage is 2.5 mg once daily regardless of meals. ONGLYZA should be administered following hemodialysis. Assess renal function before starting ONGLYZA and periodically thereafter.

Indication and Limitations of Use

ONGLYZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

ONGLYZA is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

Please see US Full Prescribing Information and Medication Guide for ONGLYZA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.