Reference

Design (n)

Duration

(week)

Primary outcome (s)

Interventions

Results

Safety outcome)

Bailey (2013)

MC, R, PC, DB, PGT

(476)

102

HbA_1c changes from baseline at 78 weeks.

MET only

MET + DAP

· 2.5 mg

· 5 mg

· 10 mg

0.02%

−0.48%*

−0.58%*

−0.78%*

· Three deaths reported, 2 in DAP 2.5 mg group (cardiac arrest and MI) and 1 in placebo group (lung cancer)

· UTI incidence was higher in DAP 10 mg.

· In general, renal impairment was observed to a great extent in DAP groups than placebo.

· A significant beneficial reduction of blood pressure was observed in patients with hypertension with DAP groups.

Henry (2012)

MC, R, DB, ACS (598)

24

HbA_1c changes from baseline at 24 weeks.

· MET only

· DAP 5 mg

· DAP + MET

−1.35

−1.19

−2.05*

· No major hypoglycemia was observed in any groups.

· Mild to moderate ADR among groups.

· Diarrhea was more common in MET groups than DAP groups.

· UTI was reported more frequently in DAP + MET groups.

· Significant changes in the renal function were not detected.

· A significant reduction of blood pressure was observed in patients with hypertension with DAP + MET groups.

Henry (2012)

MC, R, DB, ACS (638)

24

HbA_1c changes from baseline at 24 weeks.

· MET only

· DAP 10 mg

· DAP + MET

−1.44

−1.45

−1.98*

Bailey (2010)

MC, R, PC, DB, PGT

(546)

24

HbA_1c changes from baseline at 24 weeks.

MET only

MET + DAP

· 2.5 mg

· 5 mg

· 10 mg

−0.30%

−0.67%*

−0.70%*

−0.84%*

· No major hypoglycemia was observed in any groups.

· Discontinuation of therapy was less frequent in the DAP groups.

· UTI was observed in all groups, but was higher in DAP groups.

· No major differences were observed in serum electrolytes, renal function, and lipid profiles.

· A significant reduction of blood pressure was observed in patients with hypertension with DAP groups.