print_label | resize_label

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

Head-to-Head vs Glipizide (a Sulfonylurea) + Metformin: 2- and 4- Year Data

Select a category or scroll  to learn more.

 

REDUCTION IN A1C LEVELS AT 2 AND 4 YEARS

Exploratory end point: Adjusted mean change in A1C from baseline with FARXIGA + metformin vs glipizide + metformin at 2 and 4 years1

Exploratory end point: Adjusted mean change in A1C from baseline
Primary end point: With Farxiga™ (dapagliflozin) + metformin, reductions in A1C were non-inferior to glipizide + metformin at 52 weeks
Exploratory end point: Adjusted mean change in A1C from baseline
Exploratory end point: Adjusted mean change in A1C from baseline

BL=baseline.

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

*A1C reduction was an exploratory end point in the extension-phase trial.

 

WEIGHT REDUCTION AT 2 AND 4 YEARS

Exploratory end point: Mean weight reduction from baseline with FARXIGA + metformin vs glipizide + metformin at 2 and 4 years1

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

aThe discrepancy between the weight change between treatments and the total weight change is due to rounding.

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 an exploratory end point in the extension-phase trial.

  • During the extension periods, common adverse events (≥5%) reported by subjects taking either FARXIGA + metformin or glipizide + metformin were (reported respectively) nasopharyngitis (17.2%, 18.6%), influenza (12.3%, 11.0%), urinary tract infection (11.8%, 7.8%), hypertension (10.8%, 15.2%), bronchitis (8.9%, 7.8%), back pain (8.6%, 10.3%), diarrhea (8.6%, 10.3%), headache (7.9%, 5.9%), upper respiratory tract infection (7.6%, 11.3%), arthralgia (6.7%, 10.0%), gastroenteritis (6.7%, 5.6%), cough (6.4%, 8.8%), dizziness (6.2%, 10.0%), and pain in extremity (5.2%, 4.7%)1
  • 39% (156/400) of patients in the FARXIGA group and 45.4% (182/401) of patients in the glipizide group discontinued from the study due to lack of glycemic control, or required rescue therapy1

 

SIGNIFICANT BLOOD PRESSURE REDUCTION

Exploratory end point: Mean change from baseline in systolic BP with FARXIGA + metformin relative to glipizide + metformin at 2 and 4 years1

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

BL=baseline.

Values are last observation carried forward.

FARXIGA is not indicated for the treatment of hypertension.

Blood pressure reduction was an exploratory end point in the extension-phase trial.

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.

 

STUDY DESIGN1-3

Head-to-Head vs Glipizide (a Sulfonylurea)

A 52-week, phase 3, multicenter, randomized, double-blind, parallel-group, noninferiority study with trial extensions to 2 years and 4 years. At the end of 4 years, 51% of patients completed the study.

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

Study Objective

Evaluate the efficacy and safety of FARXIGA compared with glipizide in adults with type 2 diabetes who had inadequate glycemic control (A1C >6.5% and ≤10.0%) with metformin.

 

Study Length

52 Weeks

Extension 1 (52 weeks)

Extension 2 (104 weeks)

 

 

Key Inclusion Criteria

Adult patients with type 2 diabetes who had inadequate glycemic control (A1C >6.5% and ≤10.0%) and had a body mass index (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 2 years and 4 years

Select Secondary End Points

  • Change in total body weight from baseline at 2 years and 4 years
  • Change in seated systolic blood pressure at 2 years and 4 years