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

Head-to-Head vs Glipizide (a Sulfonylurea) + Metformin: 1-Year Data

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COMPARABLE REDUCTION IN A1C LEVELS AT 1 YEAR

Primary end point: With FARXIGA + metformin, reductions in A1C levels were noninferior to glipizide + metformin at 1 year1,2,a

Primary end point: With FARXIGA® (dapagliflozin) + metformin, reductions in A1C were noninferior to glipizide + metformin at 52 weeks
Primary end point: With Farxiga™ (dapagliflozin) + metformin, reductions in A1C were non-inferior to glipizide + metformin at 52 weeks

aPatients on metformin ≥1500 mg per day were randomized following a 2-week placebo lead-in period to glipizide 5 mg or dapagliflozin 2.5 mg and were up-titrated over 18 weeks to optimal glycemic effect (FPG <110 mg/dL, <6.1 mmol/L) or to the highest dose level (up to glipizide 20 mg and FARXIGA 10 mg) as tolerated by patients. At the end of the titration period, 87% of patients treated with FARXIGA had been titrated to the maximum study dose (10 mg) vs 73% treated with glipizide (20 mg). Dapagliflozin 2.5 mg is not an FDA-approved dose.

BL=baseline.

Values are last observation carried forward and represent adjusted mean change from baseline.

 

SIGNIFICANT WEIGHT REDUCTION AT 1 YEAR

Secondary end point: Significant mean weight reduction from baseline with FARXIGA + metformin vs glipizide + metformin at 1 year1,2

Secondary end point: significant weight reductions with FARXIGA vs glipizide at 52 weeks
Secondary end point: significant weight reductions with FARXIGA vs glipizide at 52 weeks
  • • FARXIGA + metformin (n=400) (BL=194.9 lb)
  • • Glipizide + metformin (n=401) (BL=193.1 lb)

bP<0.0001.

BL=baseline.

Values are last observation carried forward and represent adjusted mean change from baseline.

FARXIGA is not indicated for weight loss.

*Weight reduction was a secondary end point.

 

SIGNIFICANT BLOOD PRESSURE REDUCTION AT 1 YEAR

A secondary end point: Significant mean change from baseline in systolic BP with FARXIGA + metformin relative to glipizide + metformin at 1 year1-3

Secondary end point: Significant mean change from baseline in systolic BP with FARXIGA + metformin relative to glipizide + metformin at 52 weeks
Secondary end point: Significant mean change from baseline in systolic BP with FARXIGA + metformin relative to glipizide + metformin at 52 weeks

cP<0.0001 vs glipizide + metformin.

BL=baseline.

Values are last observation carried forward.

FARXIGA is not indicated for the treatment of hypertension.

Blood pressure reduction was a secondary end point.

Hypotension: FARXIGA causes intravascular volume contraction, and symptomatic hypotension can occur. Assess and correct volume status before initiating FARXIGA in patients with impaired renal function, elderly patients, or patients on loop diuretics. Monitor for hypotension.

Lower Rate of Hypoglycemia

  • 1.7% (n=7) OF PATIENTS TAKING FARXIGA EXPERIENCED MINOR HYPOGLYCEMIA VS 36.0% (n=147) WITH GLIPIZIDE OVER 52 WEEKS. 0% OF PATIENTS TAKING FARXIGA EXPERIENCED MAJOR§ HYPOGLYCEMIA VS 0.7% (n=3) WITH GLIPIZIDE OVER 52 WEEKS.1

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.

§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.

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.

 

STUDY DESIGN1,2

Head-to-Head vs Glipizide (a Sulfonylurea)

Randomized, 1-year, double-blind, parallel-group, active-controlled, multicenter, noninferiority, phase 3 study

Randomization wth Dapagliflozin 2.5 mg to 10 mg + metformin (n=400), Glipizide 5 to 20 mg + metformin (n=401)

ǁPatients received dapagliflozin 2.5 mg or glipizide 5 mg and were up-titrated to optimal glycemic effect (FPG <110 mg/dL) or to the highest dose level (up to FARXIGA 10 mg and glipizide 20 mg) as tolerated by patients. Metformin dose was ≥1500 mg/day. 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 plus metformin vs glipizide plus metformin in adult patients with type 2 diabetes whose A1C is inadequately controlled on metformin monotherapy.

 

Study Length

1 year

 

 

Key Inclusion Criteria

Adult patients with type 2 diabetes who had inadequate glycemic control (A1C >6.5% and ≤10.0%) and had a BMI of ≤45 kg/m2. Patients with systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg were excluded.

 

 

Study Dosing

FARXIGA was up-titrated to a maximum dose of 10 mg. Glipizide was up-titrated to a maximum dose of 20 mg. Up-titration occurred over 18 weeks, after which doses were kept constant unless down-titration was required to prevent hypoglycemia.

FARXIGA tablet shown is not actual size.

Primary End Point

Change in A1C from baseline at 1 year

Select Secondary End Points

  • Change in total body weight from baseline at 1 year
  • Change in seated systolic blood pressure at 1 year