Table 1 Baseline characteristics of included trials

Intervention

Intensive policy with a sulphonylura or insulin vs conventional policy with diet

intensive blood-glucose control policy with metformin vs diet alone

Addition of pioglitazone or placebo to usual diabetes therapy

Intensive (glicazide plus other drugs) vs standard glucose control

Intensive therapy vs standard therapy

Prandial vs basal strategy

Intensive or standard glucose control

Addition of rosiglitazone or combination of metformin and sulfonylurea

Insulin sensitization vs insulin provision therapy

Routine vs intensive treatment of multiple risk factors

Addition of Saxagliptin vs placebo to usual diabetes therapy

Addition of Alogliptin vs placebo to usual diabetes therapy

Intensified insulin-based glycaemic control vs conventional glucose-lowering treatment

Aleglitazar 150 μg or placebo daily

Add sitagliptin or placebo to existing therapy

Publication year

1998

1998

2005

2008

2008

2009

2009

2009

2009

2011

2013

2013

2014

2015

2015

Location

23 centers in England

15 centers in England

321 centers in 19 countries^a

215 centers in 20 countries^b

77 centers in USA

105 centers in 17 countries^c

20 centers in USA

364 centers in 25 countries^d

49 centers in 6 countries^e

334 practices in Denmark, Netherlands, and UK

788 sites in 26 countries^f

898 sites in 48 countries^g

19 hospitals in Swedish

720 hospitals in 26 countries^h

673 sites in 38 countriesⁱ

Study design

Randomized, Open label

Randomized, Open label

Randomized, Placebo-controlled

Factoria randomized trial

Randomized, 2 × 2 factorial design

Randomized, open label

Open label, permuted-block design

Randomized, open label

Randomized, 2by2 factorial design

Cluster-randomized, parallel-group trial

Randomized, double-blind, placebo-controlled

Randomized, double-blind

Randomized, open-label

Randomized, double blind, placebo controlled trial

Randomized, double blind, placebo controlled, event driven trial

Number of patients

3867

1704

5238

11,140

10,251

1115

1791

4447

2368

3055

16,492

5380

1240

7226

14,671

Duration of diabetes

Newly diagnosed

Newly diagnosed

8 ± 6

8 ± 6^†

10

9 ± 7.2^†

11.5 ± 7.5^†

7 ± 4.8^†

10.4 ± 8.7

Screened diabetes

10.3 ± 2.8^†

7.2 ± 2.8^†

10.5 ± 5.4^†

8.6 ± 7.7

9.4 ± 2.6*

Population

Newly diagnosed T2DM

Newly diagnosed T2DM

T2DM with macrovascular disease

T2DM, history of macrovascular or microvascular disease or at least one other CV risk factor

T2DM with established CVD or additional CV risk factors

T2DM after acute MI

T2DM

T2DM

T2DM and heart disease

Screen detected T2DM

T2DM with history of CV event or at risk for

T2DM with ACS within 15–90 before randomization

T2DM and acute MI

Type 2 diabetes with hospitalized for ACS

Type 2 diabetes with established cardiovascular disease

Average follow up (years)

10.1

10.7

2.9

5.0

3.5

2.6

5.6

5.5

5.3

5.3

2.1

18 months

3.4

104 weeks

3

Age

54 (48–60)*

53 ± 8.6^†

62 ± 8

66 ± 6

62 ± 7

61 ± 9.7

60 ± 9

58 ± 8

62 ± 9

60 ± 6.8

65 ± 8.5

61

67.5 ± 9.4

61 ± 10

66.0 ± 8.0

BMI (kg/m²)

27.5 ± 5.2

31.7 ± 4.9^†

31 ± 5

28 ± 5

32 ± 6

29.1 ± 4.8^†

31 ± 4

31.5 ± 4.7^†

31.7 ± 6.0

31.6 ± 5.6

31.1 ± 5.6

28.7 ± 11.6

27.1 ± 4.3

28.6 ± 1.7

30.2 ± 5.7

HbA1c at baseline (100 %)

7.1 ± 1.5

7.2 ± 1.5†

7.9 ± 1.4

7.5 ± 1.6

8.3 ± 1.1

8.3 ± 1.5

9.4 ± 2.0

7.9 ± 0.7

7.7 ± 1.6

7.0 ± 1.6

8.0 ± 1.4

8.0 ± 1.1

8.0 ± 1.9

7.8 ± 1.7^†

7.3 ± 0.7

Intervention group

7.0 ± 1.5*

8.3

7.0

6.5 ± 0.99

6.4 ± 0.6

7.7 ± 0.1

6.9 ± 0.6*

7.5

7.0 ± 1.2

6.6 ± 0.95

7.7

7.7

7.3 ± 1.9

7.03

7.1

Conventional group

7.9 ± 1.4*

8.8

7.6

7.2 ± 1.4

7.5 ± 0.7

7.8 ± 0.1

8.4 ± 1.1*

7.8

7.5 ± 1.4

6.7 ± 0.95

7.9

8.0

7.6

7.77

7.5

Change in HbA1c^‡

0.1

−1.1

0.9

1.0

1.9

0.6

1.5

0.4

0.7

0.4

0.3

0.3

0.7

0.8

0.2