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A TREATMENT FOR ADULTS WITH TYPE 2 DIABETES MELLITUS, IN ADDITION TO DIET AND EXERCISEDapagliflozin 10 mg + Metformin XR vs Metformin XR Alone

SIGNIFICANT REDUCTION IN A1C LEVELS WHEN
PATIENTS NEED MORE

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

Chart shows Clinical trial results for Dapagliflozin 10 mg + Metformin XR vs Metformin XR Alone with a primary end point: mean reduction in A1C levels in treatment-naive patients at 24 weeks. Dapagliflozin 10 mg + metformin XR showed a mean change from baseline A1C-2.0% and metformin XR monotherapy -1.4%Chart shows Clinical trial results for Dapagliflozin 10 mg + Metformin XR vs Metformin XR Alone with a primary end point: mean reduction in A1C levels in treatment-naive patients at 24 weeks. Dapagliflozin 10 mg + metformin XR showed a mean change from baseline A1C-2.0% and metformin XR monotherapy -1.4%

 

Dapagliflozin 10-mg monotherapy demonstrated a 1.5% reduction in A1C levels from baseline (n=219; BL=9.0%)1,2,c


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 10-mg monotherapy.

cNoninferior vs metformin XR monotherapy.

BL=mean baseline.

There have been no clinical efficacy studies conducted with XIGDUO XR. Bioequivalence of XIGDUO XR to dapagliflozin and metformin XR coadministered as individual tablets was demonstrated in healthy subjects.

SIGNIFICANT WEIGHT REDUCTION

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

Chart shows the mean change in weight (lbs) with  significantly greater weight reduction vs metformin xr alone. Down arrows show weight loss with Dapagliflozin 10 mg + metformin XR -7.3lb vs Metformin XR monotherapy -3.1lbChart shows the mean change in weight (lbs) with  significantly greater weight reductions vs metformin xr alone. Down arrows show weight loss with Dapagliflozin 10 mg + metformin XR -7.3lb vs Metformin XR monotherapy -3.1lb

 

Dapagliflozin 10-mg monotherapy demonstrated a 6.0 lb weight reduction from baseline (n=219; BL=195.1 lb)1,2,e


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


dThe median metformin XR dose was 2000 mg per day.

eP<0.0001 vs metformin XR monotherapy.

BL=mean baseline.

 
XIGDUO XR is not indicated for weight loss.

STUDY DESIGN1,2

Dapagliflozin 10 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=638)
Randomization
Dapagliflozin 10 mg + metformin XR (n=211)
Metformin XR + placebo (n=208)
Dapagliflozin 10 mg + placebo (n=219)

Study Objective

Evaluate the efficacy and safety of dapagliflozin 10 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 1928.6 mg in the combination group and 1949.7 mg for the metformin XR monotherapy group.