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Table 1 Characteristics of the included study reports

From: Systematic literature review of use of blood glucose monitoring in phase III clinical studies of insulin analogs

Insulin analog type

Insulin analog

Clinical trial ID

EMA report

First author of full-text article

Year

Design

Sample size

Mean age of total

Population

DM type

Mean duration of DM in years

Male (%)

Mean HbA1c (%) at baseline

Rapid-acting

Insulin aspart (Novo Rapid)

NCT01388361

N

Mathieu [29]

2014

RCT

413

61.3

A

II

11.8

64

7.3

NCT00097071

N

Weinzimer [30]

2008

RCT

299

13.1

C

I

6.1

48

8.1

NCT00604656

N

None

2004

RCT

241

40.2

A

I

13.6

66

7.8

NCT00071448

N

None

2006

RCT

378

11.6

C

I

4.6

52

8.3

NCT01486940

N

Hermansen [27]

2004

RCT

644

39.1

A

I

15.2

63

8.4

NCT00065130

N

Pettitt [31]

2007

RCT

27

30.7

A

GDM

–

0

5.2

NCT00832182

N

None [32]*

2002

Cohort

75

–

A

I

–

–

–

NCT01707134

N

Home [33]

2006

RCT

753

38.8

A

I

15.2

58

–

Insulin glulisine (Apidra)

NCT00467376

N

None

2009

RCT

484

–

A

I, II

10.3

–

8.6

NCT00115570

N

None

2009

RCT

572

12.5

C

I

–

–

–

NCT00290979

N

None

2006

RCT

267

–

A

I

–

–

–

NCT00290927

N

None

2005

RCT

393

–

A

II

–

–

–

NCT00135057

Y

Bergenstal [34]

2008

RCT

270

55.1

A

II

13.0

44

8.2

NCT00135096

N

Ratner [35]

2011

RCT

716

53.8

A

II

14.0

44

8.4

NCT00174668

N

None

2008

RCT

310

–

A

II

–

–

–

NCT00546702

N

None

2005

CS

140

–

A

I

–

–

–

NCT00545337

N

None

2007

CS

60

34.7

A

I

12.7

45

–

NCT00174642

N

None

2009

RCT

464

58.5

A

II

–

45

9.1

NCT00272012

N

None

2007

RCT

393

–

A

II

–

–

–

NCT00135941

N

Testa [36]

2012

RCT

388

54.0

A

I, II

16.1

47

7.8

NCT00135083

N

Davidson [37]

2011

RCT

343

–

A

II

–

5

–

NCT00272064

N

Del Prato [38]

2012

RCT

241

58.3

A

II

10.9

52

8.9

NCT00271284

N

Renard [39]

2011

RCT

135

46.8

A

I

18

61

7.1

NCT00397553

N

None

2009

CS

104

35.0

A

I

25.3

–

8.8

Insulin lispro (Humalog)

F3Z-MC-IOAE

Y

None

1994

RCT

98

24.4

M

I

0.2

61

–

F3Z-MC-IOAF

Y

None

1994

RCT

377

56.1

A

II

7.8

56

–

F3Z-MC-IOAG

Y

None

1993

RCT

1037

33.4

M

I

12.1

58

8.5

F3Z-MC-IOAH

Y

None

1993

RCT

777

58.6

A

II

12.6

54

8.9

Pre-mixed

Biphasic insulin aspart (Novo Mix)

NCT00476437

N

None

2008

RCT

81

62.3

A

II

18.3

54

7.8

NCT00318786

N

Kadowaki [40]

2010

RCT

289

62.5

A

II

15.7

59

8.5

NCT00313001

N

None

2007

RCT

372

52.6

A

II

–

48

10.2

NCT00184574

N

Cucinotta [41]

2009

RCT

603

60.5

A

II

–

44

8.9

NCT00097877

N

Bergenstal [42]

2009

RCT

372

52.6

A

II

–

48

10.2

NCT00184600

N

Holman [18]

2009

RCT

708

61.7

A

II

9

64

8.5

NCT00097279

Y

Raskin [43]

2007

RCT

230

53.8

A

II

8.8

42

8.1

NCT00564668

N

None

2005

RCT

126

62.2

A

II

16.4

62

7.2

NCT00612599

N

Parkner [44]

2010

RCT

75

60.4

A

II

11.7

70

7.5

NCT00617565

Y

None

2004

RCT

219

55.8

A

I, II

11.1

56

8.8

NCT01467375

N

None [45]*

2005

CS

89

65.1

A

II

15.2

65

8.1

NCT01467323

Y

Boehm [46]

2002

RCT

294

54.0

A

I, II

15.3

58

8.3

Insulin lispro mix (Humalog Mix)

NCT00191581

N

Gao [47]

2008

RCT

120

55.7

A

I, II

11.4

40

8.1

NCT00551356

N

None

2003

RCT

53

50.4

A

II

6.5

57

–

F3Z-JE-IOMO

N

None

2003

RCT

215

55.9

A

I, II

15.0

58

–

F3Z-MC-IONA

N

None

2006

RCT

106

52.4

A

I, II

10.4

52

–

NCT00036504

N

None

2007

RCT

105

54.9

A

II

8.9

62

8.6

  1. Abbreviations: EMA European Medicines Agency; design: RCT randomized control trial, CS case series study; population: A adult, C child and/or adolescent, M mixed
  2. DM diabetes mellitus; type: I diabetes mellitus type I, II–diabetes mellitus type II, GDM-gestational diabetes; HbA1c-glycated hemoglobin
  3. *Unpublished study. Reference provides additional information