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Table 2 Glycemic efficacy of dapagliflozin when used in combination therapy in patients with type 2 diabetes mellitus

From: Efficacy and safety of dapagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, in diabetes mellitus

Study

Intervention

Mean change from baseline HbA1c, %

Mean change from baseline bodyweight (kg)

To end of main study

To end of extension

To end of main study

To end of extension

Metformin studiesa

 Bailey et al. [50]

Placebo (n = 137; 73)

−0.30

0.02

−0.9

1.4

 Bailey et al. [51] (24 weeks; 102 weeks)

 

Dapagliflozin 2.5 mg (n = 137; 82)

−0.67†

−0.48†

−2.2‡

−1.1‡

 

Dapagliflozin 5 mg (n = 137; 89)

−0.70‡

−0.58‡

−3.0‡

−1.7‡

 

Dapagliflozin 10 mg (n = 135; 95)

−0.84‡

−0.78‡

−2.9‡

−1.7‡

 Nauck et al. [53]

Dapagliflozin ≤10 mg (n = 400; 161)

−0.52

−0.10

−3.2‡

−4.0

 Del Prato et al. [56] (52 weeks; 4 years)

 

Glipizide ≤20 mg (n = 401; 141)

−0.52

0.2

1.4

1.1

 Bolinder et al. [28]

Placebo (n = 91; 49)

−0.10

−0.12

−0.88‡

−2.12

 Bolinder et al. [52] (24 weeks; 2 years)

 

Dapagliflozin 10 mg (n = 89; 60)

−0.39‡

−0.30

−2.96

−4.54

 Matthaei et al. [57]

Placebo (n = 108)

−0.17

–

−0.6

–

 

Dapagliflozin 10 mg (n = 108)

−0.86‡

–

−2.7‡

–

 Schumm-Draeger et al. [55]

Placebo (n = 101)

−0.30

–

−1.04

–

 

Dapagliflozin 2.5 mg bd (n = 100)

−0.52*

–

−2.84‡

–

 

Dapagliflozin 10 mg bd (n = 99)

−0.65‡

–

−3.2‡

–

 

Dapagliflozin 10 mg od (n = 99)

−0.59†

–

−2.76‡

–

Insulin studiesb

 Zhang et al. [60]

Placebo (n = 49)

−0.20

–

−0.95

–

 Intensive insulin therapy ± insulin sensitizers at baseline

(patients with early-stage disease)

 

Dapagliflozin 10 or 20 mg (n = 102)

−0.70† (10 mg)

–

−2.00 (10 mg)

–

(patients with early-stage disease)

−0.50† (20 mg)

−2.50 (20 mg)

 

Placebo (n = 14)

0

–

−1.55

–

(patients with late-stage disease)

 

Dapagliflozin 10 or 20 mg (n = 44)

−0.60† (10 mg)

–

−4.30 (10 mg)

–

(patients with late stage disease)

−0.80† (20 mg)

−5.05 (20 mg)

 Wilding et al. [58, 61]

Placebo (n = 193; 108)

−0.39

−0.43

0.4

1.8

 Insulin therapy ± oral antihyperglycemic drugs at baseline (24 weeks; 2 years)

 

Dapagliflozin 2.5 mg (n = 202; 134)

−0.79†

−0.64*

−0.9†

−1.0‡

 

Dapagliflozin 5 or 10 mg (n = 211; 129)

−0.89†

−0.82†

−1.0†

−1.0‡

 

Dapagliflozin 10 mg (n = 194; 142)

−0.96†

−0.78†

−1.6†

−1.5‡

  1. Key studies and their extensions
  2. bd twice daily, HbA 1c glycosylated hemoglobin, od once daily
  3. * P < 0.05 vs. placebo, ** P < 0.01 vs. placebo, † P < 0.001 vs. placebo, ‡ P < 0.0001 vs. placebo. Not all studies reported P values
  4. aAll patients were receiving metformin therapy
  5. bAll patients were receiving insulin therapy