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

FARXIGA as Add-On to Glimepiride (a Sulfonylurea)

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SIGNIFICANT REDUCTION IN A1C LEVELS1

Primary end point: Mean reduction in A1C levels with FARXIGA + glimepiride at 24 weeks1,2

Primary end point: Mean reduction in A1C levels with FARXIGA® (dapagliflozin) + glimepiride at 24 weeks
Primary end point: Mean A1C reductions with Farxiga™ (dapagliflozin) + glimepiride at 24 weeks

aP<0.0001 vs placebo + glimepiride.

BL=baseline.

Values are last observation (prior to rescue for rescued patients) carried forward and represent adjusted mean change from baseline.

Hypoglycemia: FARXIGA can increase the risk of hypoglycemia when coadministered with insulin and insulin secretagogues. Consider lowering the dose of these agents when coadministered with FARXIGA.

 

SIGNIFICANT WEIGHT REDUCTION1

Secondary end point: Mean weight reduction with FARXIGA + glimepiride at 24 weeks1,2

Secondary end point: Mean weight reductions with FARXIGA + glimepiride at 24 weeks
Secondary end point: Mean weight reductions with FARXIGA + glimepiride at 24 weeks

bP<0.0001 vs placebo + glimepiride.

BL=baseline.

Values are last observation (prior to rescue for rescued patients) carried forward and represent adjusted mean change from baseline.

FARXIGA is not indicated for weight loss.

*Weight reduction was a secondary end point.

 

STUDY DESIGN1,2

FARXIGA as Add-On to Glimepiride (a Sulfonylurea)

Randomized, double-blind, multicenter, placebo-controlled, 24-week, phase 3 trial

Randomization wth FARXIGA 5 mg + glimepiride 4 mg (n=142), FARXIGA 10 mg + glimepiride 4 mg (n=151), Dapagliflozin 2.5 mg† + glimepiride 4 mg (n=154), Placebo + glimepiride 4 mg (n=145)

Dapagliflozin 2.5 mg is not an FDA-approved dose; thus, data from this treatment group are not presented.

Study Objective

Evaluate the efficacy and safety of FARXIGA in adult patients with type 2 diabetes who have inadequate glycemic control with sulfonylurea monotherapy.

 

Study Length

24 weeks

 

 

Key Inclusion Criteria

Patients were ≥18 years of age with type 2 diabetes with an A1C of ≥7.0% and ≤10.0%, BMI ≤45 kg/m2, FPG level of ≤270.3 mg/dL, and a fasting C-peptide ≥1.0 ng/mL. Patients were given a stable dose of sulfonylurea (≥1/2 maximum recommended dose) for ≥8 weeks prior to enrollment.

 

 

Study Dosing

Patients on at least half the maximum recommended dose of sulfonylurea as monotherapy for at least 8 weeks lead-in were randomized to dapagliflozin 2.5 mg, FARXIGA 5 mg, FARXIGA 10 mg, or placebo in addition to glimepiride 4 mg per day. Down-titration of glimepiride to 2 mg or 0 mg was allowed for hypoglycemia during the treatment period; no up-titration of glimepiride was allowed.

Dapagliflozin 2.5 mg is not an FDA-approved dose; thus, data from this treatment group are not presented.

FARXIGA tablets shown are not actual sizes.

Primary End Point

Change in A1C from baseline at Week 24

Select Secondary End Point

  • Change in total body weight from baseline at Week 24