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. 2011 Jun 30;4:263–271. doi: 10.2147/DMSO.S16361

Table 2.

summary of the studies included in the review

Study Duration Drugs involved Baseline population Results
Pfützner et al20,21 76 weeks
  • saxagliptin/metformin 5/500 mg

  • saxagliptin/metformin 10/500 mg

  • saxagliptin 10 g/placebo

  • metformin 500 mg/placebo.

1306 patients, 18–77 years of age with HbA1c 8.0%–12.0%. HbA1c:
  • −2.31% for saxagliptin/metformin 5/500 mg*

  • −2.33% for saxagliptin/metformin 10/500 mg*

  • −1.55% for saxagliptin 10 mg

  • −1.79% for metformin 500 mg (*P < 0.0001 versus metformin and saxagliptin monotherapies)

Scheen et al22 18 weeks
  • saxagliptin 5 mg once daily as add on therapy to previously taken metformin

  • sitagliptin 100 mg once daily as add-on therapy to previously taken metformin.

801 patients with HbA1c between 6.5%–10% on stable metformin doses (1500–3000 mg/day). HbA1c:
  • −0.52% for saxagliptin/metformin

  • −0.62% for sitagliptin/metformin (P not significant)

De Fronzo et al23 24 weeks
  • saxagliptin 2.5 mg once daily as add on therapy to previously taken metformin

  • saxagliptin 5 mg once daily as add on therapy to previously taken metformin

  • saxagliptin 10 mg once daily as add on therapy to previously taken metformin

  • placebo as add on therapy to previously taken metformin.

743 patients taking a stable dose of metformin (1.500 but not >2.550 mg/day) HbA1c:
  • −0.59% for saxagliptin 2.5 mg/metformin*

  • −0.69% for saxagliptin 5 mg/metformin*

  • −0.58% for saxagliptin 10 mg/metformin*

  • +0.13% for placebo/metformin (*P ≤ 0.0001 versus placebo)

Goke et al24 52 weeks
  • saxagliptin 5 mg once daily as add on therapy to previously taken metformin

  • glipizide up-titrated as needed from 5 to 20 mg/day as add on therapy to previously taken metformin.

858 patients on stable metformin doses ≥1500 mg/day HbA1c:
  • −0.74% for saxagliptin/metformin

  • −0.80% for glipizide/metformin (P not significant)


Hypoglycemia:
  • 3% for saxagliptin/metformin*

  • 36.3% for glipizide/metformin (*P < 0.0001 versus glipizide/metformin)


Body weight:
  • −1.1 kg for saxagliptin/metformin*

  • +1.1 kg for with glipizide/metformin (*P < 0.0001 versus glipizide/metformin)