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Amended QUOROM (quality of reporting of meta‐analyses) flow chart of study selection
Figuras y tablas -
Figure 1

Amended QUOROM (quality of reporting of meta‐analyses) flow chart of study selection

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Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
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Figure 2

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

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Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figuras y tablas -
Figure 3

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Comparison 1 Sitagliptin, Outcome 1 Change in haemoglobin A1c from baseline to endpoint.
Figuras y tablas -
Analysis 1.1

Comparison 1 Sitagliptin, Outcome 1 Change in haemoglobin A1c from baseline to endpoint.

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Comparison 1 Sitagliptin, Outcome 2 Adverse events [n].
Figuras y tablas -
Analysis 1.2

Comparison 1 Sitagliptin, Outcome 2 Adverse events [n].

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Comparison 1 Sitagliptin, Outcome 3 Change in body weight from baseline to endpoint.
Figuras y tablas -
Analysis 1.3

Comparison 1 Sitagliptin, Outcome 3 Change in body weight from baseline to endpoint.

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Comparison 2 Vildagliptin, Outcome 1 Change in haemoglobin A1c from baseline to endpoint.
Figuras y tablas -
Analysis 2.1

Comparison 2 Vildagliptin, Outcome 1 Change in haemoglobin A1c from baseline to endpoint.

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Comparison 2 Vildagliptin, Outcome 2 Adverse events [n].
Figuras y tablas -
Analysis 2.2

Comparison 2 Vildagliptin, Outcome 2 Adverse events [n].

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Comparison 2 Vildagliptin, Outcome 3 Change in body weight from baseline to endpoint.
Figuras y tablas -
Analysis 2.3

Comparison 2 Vildagliptin, Outcome 3 Change in body weight from baseline to endpoint.

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Summary of findings for the main comparison. Summary of findings: Sitagliptin

Sitagliptin for type 2 diabetes mellitus

Patient or population: type 2 diabetes mellitus

Settings:

Intervention: Sitagliptin

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Sitagliptin

Morbidity

See comment

See comment

Not estimable

‐

See comment

Not investigated

Health‐related quality of life

See comment

See comment

Not estimable

‐

See comment

Not investigated

Change in HbA1c from baseline to endpoint
%
(follow‐up: 12 to 52 weeks)

The mean change in hba1c from baseline to endpoint ranged across control groups from
‐1.31 to 0.41

The mean Change in HbA1c from baseline to endpoint in the intervention groups was
0.54 lower
(0.58 to 0.5 lower)

6907
(11)

⊕⊕⊕⊕
high1

Change in HbA1c from baseline to endpoint ‐ Sitagliptin versus another single hypoglycaemic agent
%
(follow‐up: 12 to 24 weeks)

The mean change in hba1c from baseline to endpoint ‐ sitagliptin versus another single hypoglycaemic agent ranged across control groups from
‐1.13 to ‐0.76

The mean Change in HbA1c from baseline to endpoint ‐ Sitagliptin versus another single hypoglycaemic agent in the intervention groups was
0.33 higher
(0.18 to 0.48 higher)

592
(2)

⊕⊕⊕⊕
high1

Change in HbA1c from baseline to endpoint [%] ‐ Sitagliptin versus placebo
%
(follow‐up: 18 to 52)

The mean change in hba1c from baseline to endpoint [%] ‐ sitagliptin versus placebo ranged across control groups from
0.12 to 0.18

The mean Change in HbA1c from baseline to endpoint [%] ‐ Sitagliptin versus placebo in the intervention groups was
0.75 lower
(0.86 to 0.63 lower)

1103
(3)

⊕⊕⊕⊕
high1

Change in body weight from baseline to endpoint ‐ Sitagliptin versus placebo
kg
(follow‐up: 18 to 24 weeks)

The mean change in body weight from baseline to endpoint ‐ sitagliptin versus placebo ranged across control groups from
‐1.1 to ‐0.7

The mean Change in body weight from baseline to endpoint ‐ Sitagliptin versus placebo in the intervention groups was
0.69 higher
(0.32 to 1.06 higher)

1109
(3)

⊕⊕⊕⊕
high

Adverse events ‐ All‐cause infections
(follow‐up: 12 to 52 weeks)

Medium risk population

RR 1.29
(1.09 to 1.52)

3589
(8)

⊕⊕⊕⊕
high

77 per 1000

99 per 1000
(84 to 117)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidance
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 In type 2 diabetes mellitus glycosylated haemoglobin A1c (HbA1c) is only a weak surrogate for mortality and diabetes‐associated morbidity.

Figuras y tablas -
Summary of findings for the main comparison. Summary of findings: Sitagliptin
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Summary of findings 2. Summary of findings: Vildagliptin

Vildagliptin for type 2 diabetes mellitus

Patient or population: patients with type 2 diabetes mellitus

Settings:

Intervention: Vildagliptin

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Vildagliptin

Morbidity

See comment

See comment

Not estimable

‐

See comment

Not investigated in the included studies

Health‐related quality of life

See comment

See comment

Not estimable

‐

See comment

Not investigated in the included studies

Change in HbA1c from baseline to endpoint
%
(follow‐up: 12 to 52 weeks)

The mean change in hba1c from baseline to endpoint ranged across control groups from
‐1.4 to 0.28 %

The mean Change in HbA1c from baseline to endpoint in the intervention groups was
0.27 lower
(0.29 to 0.26 lower)

6308
(14)

⊕⊕⊕⊕
high1

Change in HbA1c from baseline to endpoint ‐ Vildagliptin versus another single hypoglycaemic agent
%
(follow‐up: 12 to 52 weeks)

The mean change in hba1c from baseline to endpoint ‐ vildagliptin versus another single hypoglycaemic agent ranged across control groups from
‐1.4 to ‐1.3

The mean Change in HbA1c from baseline to endpoint ‐ Vildagliptin versus another single hypoglycaemic agent in the intervention groups was
0.3 higher
(0.14 to 0.46 higher)

1764
(3)

⊕⊕⊕⊕
high1

Change in HbA1c from baseline to endpoint ‐ Vildagliptin versus placebo
%
(follow‐up: 12 to 52 weeks)

The mean change in hba1c from baseline to endpoint ‐ vildagliptin versus placebo ranged across control groups from
‐0.3 to 0.28

The mean Change in HbA1c from baseline to endpoint ‐ Vildagliptin versus placebo in the intervention groups was
0.32 lower
(0.34 to 0.3 lower)

1139
(6)

⊕⊕⊕⊕
high1

Change in body weight from baseline to endpoint ‐ Vildagliptin versus placebo
kg
(follow‐up: 12 to 24 weeks)

The mean change in body weight from baseline to endpoint ‐ vildagliptin versus placebo ranged across control groups from
‐1.4 to ‐0.73

The mean Change in body weight from baseline to endpoint ‐ Vildagliptin versus placebo in the intervention groups was
0.76 higher
(0.19 to 1.32 higher)

484
(3)

⊕⊕⊕⊕
high

Adverse events ‐ All‐cause infections
(follow‐up: 12 to 52 weeks)

Medium risk population

RR 1.04
(0.87 to 1.24)

3573
(10)

⊕⊕⊕⊕
high

143 per 1000

149 per 1000
(124 to 177)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidance
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 In type 2 diabetes mellitus glycosylated haemoglobin A1c (HbA1c) is only a weak surrogate for mortality and diabetes‐associated morbidity.

Figuras y tablas -
Summary of findings 2. Summary of findings: Vildagliptin
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Table 1. Study populations

Study ID

[n] randomised

[n] safety

[n] ITT

[n] finished study

comments

SITAGLIPTIN STUDIES

Aschner 2006

741

741

711

639

efficacy analyses were based on the all‐patients ‐treated population

Charbonnel 2006

701

701

677

608

efficacy analyses were based on the all‐patients‐treated population;
safety analyses were performed using the all‐patients‐as‐treated population (APaT)

Goldstein 2007

1091

1091

1056

906

efficacy analyses were based on the all‐patients‐treated population

Hanefeld 2007

555

552

535

472

efficacy analyses were based on all‐patients‐treated population

Hermansen 2007

441

441

425

364

efficacy analyses were based on the all‐patients treated population;
safety and tolerability analyses were performed in the all‐patients‐as treated population:
all randomized patients were included in the APaT population

Nauck 2007

1172

1172

793

798

Nonaka 2008

152

151

150

140

primary efficacy analysis was based on the all‐patients‐treated population

Raz 2006

521

521

495

463

efficacy analyses were based on the all‐patients‐treated population

Rosenstock 2006

353

353

337

307

efficacy analyses were performed on the all‐patients‐treated population;

Scott 2007a

743

740

725

651

efficacy analyses were based on the all‐patients‐treated population

Scott 2007b

273

272

266

254

efficacy analyses were based on the all‐patients‐treated population

VILDAGLIPTIN STUDIES

Ahren 2004

107

107

107

97

Bolli 2008

576

575

510

506

Bosi 2007

544

541

416

462

intention to treat (ITT) = primary ITT

Dejager 2007

632

625

380

511

ITT ( = primary ITT)

Fonseca 2007

296

296

290

238

Garber 2007

463

462

398

376

ITT ( = primary ITT)

Mimori 2006

291

Pi‐Sunyer 2007

354

352

340

273

Pratley 2006

100

98

98

91

Ristic 2005

279

276

272

nr

Rosenstock 2007a

786

782

697

678

ITT ( = primary ITT)

Rosenstock 2007b

607

606

592

513

Scherbaum 2008

306

nr

302

264

Schweizer 2007

780

771

760

569

Symbols & abbreviations
nr = not reported

Figuras y tablas -
Table 1. Study populations
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Comparison 1. Sitagliptin

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Change in haemoglobin A1c from baseline to endpoint Show forest plot

11

6910

Mean Difference (IV, Fixed, 95% CI)

‐0.54 [‐0.58, ‐0.50]

1.1 Sitagliptin versus placebo

6

1714

Mean Difference (IV, Fixed, 95% CI)

‐0.77 [‐0.85, ‐0.68]

1.2 Sitagliptin versus another single hypoglycaemic agent

2

592

Mean Difference (IV, Fixed, 95% CI)

0.33 [0.18, 0.48]

1.3 Sitagliptin combination therapy versus another hypoglycaemic combination

6

2890

Mean Difference (IV, Fixed, 95% CI)

‐0.40 [‐0.47, ‐0.33]

1.4 Sitagliptin versus placebo (12 weeks)

3

605

Mean Difference (IV, Fixed, 95% CI)

‐0.79 [‐0.90, ‐0.67]

1.5 Sitagliptin versus placebo (18 to 52 weeks)

3

1109

Mean Difference (IV, Fixed, 95% CI)

‐0.75 [‐0.86, ‐0.63]

2 Adverse events [n] Show forest plot

11

12416

Risk Ratio (M‐H, Fixed, 95% CI)

1.15 [1.02, 1.31]

2.1 Discontinuation due to adverse events

11

4414

Risk Ratio (M‐H, Fixed, 95% CI)

1.05 [0.77, 1.43]

2.2 Serious adverse events

11

4413

Risk Ratio (M‐H, Fixed, 95% CI)

0.97 [0.75, 1.27]

2.3 All‐cause infections

8

3589

Risk Ratio (M‐H, Fixed, 95% CI)

1.29 [1.09, 1.52]

3 Change in body weight from baseline to endpoint Show forest plot

4

1259

Mean Difference (IV, Fixed, 95% CI)

0.66 [0.37, 0.94]

3.1 Sitagliptin versus placebo

3

1109

Mean Difference (IV, Fixed, 95% CI)

0.69 [0.32, 1.06]

3.2 Sitagliptin versus another single hypoglycaemic agent

1

150

Mean Difference (IV, Fixed, 95% CI)

0.6 [0.13, 1.07]
Figuras y tablas -
Comparison 1. Sitagliptin
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Comparison 2. Vildagliptin

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Change in haemoglobin A1c from baseline to endpoint Show forest plot

14

6308

Mean Difference (IV, Fixed, 95% CI)

‐0.27 [‐0.29, ‐0.26]

1.1 Vildagliptin versus placebo

6

1139

Mean Difference (IV, Fixed, 95% CI)

‐0.32 [‐0.34, ‐0.30]

1.2 Vildagliptin versus another single hypoglycaemic agent

3

1764

Mean Difference (IV, Fixed, 95% CI)

0.30 [0.14, 0.46]

1.3 Vildagliptin combination therapy versus another hypoglycaemic combination

6

1756

Mean Difference (IV, Fixed, 95% CI)

‐0.05 [‐0.10, 0.01]

1.4 Vildagliptin versus placebo (12 weeks)

3

361

Mean Difference (IV, Fixed, 95% CI)

‐0.90 [‐1.05, ‐0.75]

1.5 Vildagliptin versus placebo (18 to 52 weeks)

4

1288

Mean Difference (IV, Fixed, 95% CI)

‐0.26 [‐0.28, ‐0.24]

2 Adverse events [n] Show forest plot

13

11562

Risk Ratio (M‐H, Fixed, 95% CI)

0.99 [0.87, 1.14]

2.1 Discontinuation due to adverse events

13

4543

Risk Ratio (M‐H, Fixed, 95% CI)

1.02 [0.75, 1.38]

2.2 Serious adverse events

11

3446

Risk Ratio (M‐H, Fixed, 95% CI)

0.87 [0.64, 1.17]

2.3 All‐cause infections

10

3573

Risk Ratio (M‐H, Fixed, 95% CI)

1.04 [0.87, 1.24]

3 Change in body weight from baseline to endpoint Show forest plot

5

1349

Mean Difference (IV, Fixed, 95% CI)

1.32 [1.02, 1.63]

3.1 Vildagliptin versus placebo

3

484

Mean Difference (IV, Fixed, 95% CI)

0.76 [0.19, 1.32]

3.2 Vildagliptin versus another single hypoglycaemic agent

2

865

Mean Difference (IV, Fixed, 95% CI)

1.55 [1.19, 1.91]
Figuras y tablas -
Comparison 2. Vildagliptin
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