print_label | resize_label

A TREATMENT FOR ADULTS WITH TYPE 2 DIABETES MELLITUS, IN ADDITION TO DIET AND EXERCISEDapagliflozin 5 mg + Metformin XR vs Metformin XR Alone

SIGNIFICANT REDUCTION IN A1C LEVELS VS METFORMIN XR ALONE

Primary end point: Mean reduction in A1C levels in treatment-naive patients at 24 weeks1,2,a

Clinical trials show significantly greater reduction in A1C levels for Dapagliflozin 5 mg + Metformin XR vs Metformin XR monotherapy where the primary end point: mean A1C reduction in treatment-naive patients at 24 weeks. The chart shows downward arrows against the mean change from baseline A1C with Dapagliflozin 5 mg + metformin XR showed a change of A1C of -2.1% and metformin XR monotherapy of -1.4%.Clinical trials show significantly greater reduction in A1C levels for Dapagliflozin 5 mg + Metformin XR vs Metformin XR monotherapy where the primary end point: mean A1C reduction in treatment-naive patients at 24 weeks. The chart shows downward arrows against the mean change from baseline A1C with Dapagliflozin 5 mg + metformin XR showed a change of A1C of -2.1% and metformin XR monotherapy of -1.4%.

 

Dapagliflozin 5-mg monotherapy demonstrated a 1.2% reduction in A1C levels from baseline (n=203; BL=9.1%)1,2


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

Dapagliflozin + metformin XR were administered as separate tablets.


aThe median metformin XR dose was 2000 mg per day.

bP<0.0001 vs metformin XR monotherapy or dapagliflozin 5-mg monotherapy.

BL=mean baseline.

SIGNIFICANTLY GREATER WEIGHT REDUCTION VS METFORMIN XR ALONE

Secondary end point: Mean weight reduction in treatment-naive patients at 24 weeks1,2,c

Clinical trial results for Dapagliflozin 5 mg + Metformin XR vs Metformin XR monotherapy alone with a secondary end point: Mean weight reduction in treatment-naive patients at 24 weeks. Dapagliflozin 5 mg + metformin XR showed a mean change in weight (lb) -6.0lb and metformin XR monotherapy -2.9lb.Clinical trial results for Dapagliflozin 5 mg + Metformin XR vs Metformin XR monotherapy alone with a secondary end point: Mean weight reductions in treatment-naive patients at 24 weeks. Dapagliflozin 5 mg + metformin XR showed a mean change in weight (lb) -6.0lb and metformin XR monotherapy -2.9lb.

 

Dapagliflozin 5-mg monotherapy demonstrated a 5.7 lb weight reduction from baseline (n=203; BL=190.0 lb)1,2


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


cThe median metformin XR dose was 2000 mg per day.

dP<0.0001 vs metformin XR monotherapy.

BL=mean baseline.

XIGDUO XR is not indicated for weight loss.

STUDY DESIGN1,2

Dapagliflozin 5 mg + Metformin XR vs Metformin XR Alone
Randomized, double-blind, active-controlled, multicenter, 24-week phase 3 trial
Treatment-naive A1C ≥7.5% and ≤12.0%
(N=603)
Randomization
Dapagliflozin 5 mg + metformin XR (n=194)
Metformin XR + placebo (n=201)
Dapagliflozin 5 mg + placebo (n=203)

Study Objective

Evaluate the efficacy and safety of dapagliflozin 5 mg plus metformin XR in treatment-naive adult patients whose type 2 diabetes cannot be controlled with diet and exercise alone.

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

Study Length

24 weeks

Key Inclusion Criteria

Patients were 18 to 77 years of age with type 2 diabetes who had inadequate glycemic control (A1C ≥7.5% and ≤12.0%) and had a C-peptide ≥0.33 nmol/L and a body mass index (BMI) ≤45 kg/m2.

Study Dosing

The metformin XR dose was up-titrated weekly in 500-mg increments, as tolerated, up to a maximum of 2000 mg daily. Mean metformin XR dose was 1773.5 mg in the combination group and 1843.6 mg for the metformin XR monotherapy group.