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

FARXIGA as Add-On to Insulin ± Oral Antidiabetic(s)

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REDUCED A1C LEVELS WHEN ADDED TO INSULIN ± ORAL ANTIDIABETIC(S)1

Primary end point: FARXIGA achieved significant reduction in A1C levels when added to insulin ± up to 2 oral antidiabetic agents (OADs) at 24 weeks1,2

Primary end point: FARXIGA® (dapagliflozin) achieved significant reduction in A1C levels when added to insulin ± up to 2 oral antidiabetic agents (OADs) at 24 weeks
Primary end point: Farxiga™ (dapagliflozin) achieved significant A1C reductions when added to insulin ± up to 2 oral antidiabetic agents (OADs) at 24 weeks

aP<0.0001 vs placebo + insulin.

BL=baseline; OAD=oral antidiabetic.

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

Rates of hypoglycemia

  • At 24 weeks, there was 1 episode of major§ hypoglycemia reported in the FARXIGA 5 mg and 10 mg plus insulin groups and 1 episode in the insulin plus placebo group. Minor? episodes were reported in 43.4%, 40.3%, and 34.0% of patients in the FARXIGA 5 mg or 10 mg plus insulin and the insulin plus placebo groups, respectively.1

± up to 2 OADs.

§Major episodes of hypoglycemia were defined as symptomatic episodes requiring external (third-party) assistance due to severe impairment in consciousness or behavior with a capillary or plasma glucose value <54 mg/dL and prompt recovery after glucose or glucagon administration.

?Minor episodes of hypoglycemia were defined as either a symptomatic episode with a capillary or plasma glucose measurement <63 mg/dL regardless of need for external assistance, or an asymptomatic capillary or plasma glucose measurement <63 mg/dL that does not qualify as a major episode.

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.

 

REDUCED WEIGHT WHEN ADDED TO INSULIN1

A secondary end point: Significant weight reduction with FARXIGA when added to insulin ± up to 2 OADs at 24 weeks1,2

Secondary end point: significant weight reductions with FARXIGA when added to insulin ± up to 2 OADs at 24 weeks
Secondary end point: significant weight reductions with FARXIGA when added to insulin ± up to 2 OADs at 24 weeks

bP<0.0001 + insulin ± up to 2 OADs.

BL=baseline; OAD=oral antidiabetic.

± up to 2 OADs.

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.

 

INSULIN DOSE REDUCTIONS1

 

-5.7 IU/DAY PLACEBO-ADJUSTED REDUCTION IN REQUIRED MEAN DOSE OF INSULIN WITH FARXIGA 5 MG AT WEEK 24 (P<0.0001; BASELINE DOSES WERE 77.0 IU AND 73.7 IU FOR FARXIGA 5 MG AND PLACEBO, RESPECTIVELY)1,2

-6.2 IU/DAY PLACEBO-ADJUSTED REDUCTION IN REQUIRED MEAN DOSE OF INSULIN WITH FARXIGA 10 MG AT WEEK 24 (P<0.0001; BASELINE DOSES WERE 78.0 IU AND 73.7 IU FOR FARXIGA 10 MG AND PLACEBO, RESPECTIVELY)1,2

± up to 2 OADs.

A secondary end point: Mean daily insulin dose reductions at 24 weeks1

FARXIGA 10 mg

+ insulin ± ≤2 OADs

Placebo

+ insulin ± ≤2 OADs

19.6%c 11.0%

cP<0.05 vs placebo.

Values are last observation (after rescue) carried forward.

 

Insulin dose reduction was a secondary end point.

 

STUDY DESIGN1,2

FARXIGA as Add-On to Insulin ± Oral Antidiabetic(s)

24-week, randomized, double-blind, placebo-controlled, parallel-group, international, multicenter trial

Randomization with FARXIGA 5 mg + insulin regimen ± ≤2 OAD(s) (n=211), FARXIGA 10 mg + insulin regimen ± ≤2 OAD(s) (n=194), Dapagliflozin 2.5 mg + insulin regimen ± ≤2 OAD(s) (n=202)Placebo + insulin regimen ± ≤2 OAD(s) (n=193)

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 inadequately controlled with insulin and up to 2 oral antidiabetic agents (OADs).

 

Study Length

24 weeks

 

 

Key Inclusion Criteria

Men and women 18 to 80 years of age were enrolled if they had type 2 diabetes mellitus, inadequate glycemic control (A1C ≥7.5% and ≤10.5%), and a BMI of 45 kg/m2 or less. Participants had to have received a stable insulin regimen with a mean daily insulin dose of 30 IU or more for at least 8 weeks, with daily insulin requirements varying by more than 10% on no more than one occasion in the 7 days before randomization. Additional treatment with stable doses of up to 2 OADs was allowed. Patients were stratified into 2 strata (with and without OADs).

 

 

Study Dosing

Patients were randomized 1:1:1:1 to dapagliflozin 2.5 mg,# FARXIGA 5 mg, FARXIGA 10 mg, or placebo once daily in addition to open-label therapy with their usual daily dose of insulin and existing OADs. Mean dose of insulin was ≥30 IU of injectable insulin per day, in addition to current regimen of up to 2 OADs (if applicable).

#Dapagliflozin 2.5 mg is not an FDA-approved dose.

FARXIGA tablets shown are not actual sizes.

Primary End Point

Change in A1C from baseline at Week 24

Select Secondary End Points

  • Change in total body weight from baseline at Week 24
  • Change in mean daily insulin dose from baseline at Week 24
  • Change in the percent of patients who reduced their insulin dose by >10% at Week 24