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

FARXIGA as Add-On to Pioglitazone (a Thiazolidinedione)

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SIGNIFICANT REDUCTION IN A1C LEVELS1

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

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

aP<0.0001 vs placebo + pioglitazone.

BL=baseline.

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

Select Important Safety Information

Use in Specific Populations

  • Pregnant Women: There are no adequate and well-controlled studies of FARXIGA in pregnant women. Consider appropriate alternative therapies, especially during the second and third trimesters. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus
  • Nursing Mothers: Discontinue FARXIGA or discontinue nursing

 

WEIGHT CHANGES1

A secondary end point: Mean weight changes with FARXIGA + pioglitazone at 24 weeks1,2

Secondary end point: Mean weight changes with FARXIGA + pioglitazone at 24 weeks
Secondary end point: Mean weight changes with FARXIGA + pioglitazone at 24 weeks

bP<0.0001 vs placebo + pioglitazone.

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 Pioglitazone (a Thiazolidinedione)

Randomized, double-blind, placebo-controlled, multicenter, parallel-group, 24-week study

Randomization wth FARXIGA 5 mg + pioglitazone (n=141), FARXIGA 10 mg + pioglitazone (n=140), Placebo + pioglitazone (n=139)

Patients had received 12 weeks of pioglitazone 30 or 45 mg per day.

Study Objective

Evaluate the efficacy and safety of FARXIGA in adult patients with inadequate glycemic control on pioglitazone monotherapy.

 

Study Length

24 weeks

 

 

Key Inclusion Criteria

Patients were ≥18 years of age with type 2 diabetes. At prerandomization, patients had an A1C of ≥7.0% and ≤10.5%. Patients had a BMI of ≤45 kg/m2 and a fasting C-peptide ≥1.0 ng/mL. Patients were divided into 2 groups.

Group A

  • ≥12 weeks of pioglitazone 30 mg/day or 45 mg/day
  • ≥7.0% and ≤10.5%

Group B

  • Drug-naïve for the previous 10 weeks and had an A1C ≥8.0% and ≤11.0%

OR

  • Had received pioglitazone 15 mg/day or any dose of rosiglitazone with an A1C ≥8.0% and ≤11.0%

OR

  • Had received ≥8 weeks of metformin ≤1700 mg/day or sulfonylurea less than or equal to half the maximal dose with A1C  ≥7.0% and ≤11.0%

 

 

Study Dosing

Patients on a stable dose of pioglitazone of 45 mg per day (or 30 mg per day, if 45 mg per day was not tolerated) for 12 weeks were randomized after a 2-week lead-in period to 5 or 10 mg of FARXIGA or placebo in addition to their current dose of pioglitazone. Dose titration of FARXIGA or pioglitazone was not permitted during the study.

FARXIGA tablets shown are not actual sizes.

Primary End Point

Change in A1C from baseline with each dose level of FARXIGA plus pioglitazone vs placebo plus pioglitazone at Week 24

Select Secondary End Point

  • Change in total body weight from baseline at Week 24