Alpha‐glucosidase inhibitors for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk of developing type 2 diabetes mellitus

Suzanne VL Moelands; Peter LBJ Lucassen; Reinier P Akkermans; Wim JC De Grauw; Floris A Van de Laar

doi:10.1002/14651858.CD005061.pub3

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Figure 1

Trial flow diagram

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included trials (blank cells indicate that the particular outcome was not measured in some trials).

T2DM: type 2 diabetes mellitus

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included trial (blank cells indicate that the particular outcome was not measured in some trials)

ABC: Alpha‐glucosidase‐inhiT2DM: type 2 diabetes mellitus

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Analysis 1.1

Comparison 1 AGI versus placebo, Outcome 1 All‐cause mortality.

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Analysis 1.2

Comparison 1 AGI versus placebo, Outcome 2 Incidence of type 2 diabetes.

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Analysis 1.3

Comparison 1 AGI versus placebo, Outcome 3 Serious adverse events.

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Analysis 1.4

Comparison 1 AGI versus placebo, Outcome 4 Cardiovascular mortality.

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Analysis 1.5

Comparison 1 AGI versus placebo, Outcome 5 Non‐fatal myocardial infarction.

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Analysis 1.6

Comparison 1 AGI versus placebo, Outcome 6 Non‐fatal stroke.

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Analysis 1.7

Comparison 1 AGI versus placebo, Outcome 7 Congestive heart failure.

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Analysis 1.8

Comparison 1 AGI versus placebo, Outcome 8 Non‐serious adverse events.

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Analysis 1.9

Comparison 1 AGI versus placebo, Outcome 9 Hypoglycaemia.

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Analysis 1.10

Comparison 1 AGI versus placebo, Outcome 10 Fasting plasma glucose.

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Analysis 1.11

Comparison 1 AGI versus placebo, Outcome 11 2‐h glucose measurements.

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Analysis 1.12

Comparison 1 AGI versus placebo, Outcome 12 HbA1c.

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Analysis 1.13

Comparison 1 AGI versus placebo, Outcome 13 Change in total cholesterol.

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Analysis 1.14

Comparison 1 AGI versus placebo, Outcome 14 Change in HDL‐cholesterol.

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Analysis 1.15

Comparison 1 AGI versus placebo, Outcome 15 Change in LDL‐cholesterol.

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Analysis 1.16

Comparison 1 AGI versus placebo, Outcome 16 Change in triglycerides.

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Analysis 1.17

Comparison 1 AGI versus placebo, Outcome 17 Change in body weight.

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Analysis 1.18

Comparison 1 AGI versus placebo, Outcome 18 Change in body mass index.

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Analysis 1.19

Comparison 1 AGI versus placebo, Outcome 19 Change in diastolic blood pressure.

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Analysis 1.20

Comparison 1 AGI versus placebo, Outcome 20 Change in systolic blood pressure.

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Analysis 2.1

Comparison 2 AGI versus metformin, Outcome 1 All‐cause mortality.

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Analysis 2.2

Comparison 2 AGI versus metformin, Outcome 2 Incidence of type 2 diabetes.

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Analysis 2.3

Comparison 2 AGI versus metformin, Outcome 3 Fasting plasma glucose.

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Analysis 2.4

Comparison 2 AGI versus metformin, Outcome 4 2‐h glucose measurements.

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Analysis 2.5

Comparison 2 AGI versus metformin, Outcome 5 Change in total cholesterol.

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Analysis 2.6

Comparison 2 AGI versus metformin, Outcome 6 Change in triglycerides.

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Analysis 2.7

Comparison 2 AGI versus metformin, Outcome 7 Change in body mass index.

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Analysis 2.8

Comparison 2 AGI versus metformin, Outcome 8 Change in diastolic blood pressure.

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Analysis 2.9

Comparison 2 AGI versus metformin, Outcome 9 Change in systolic blood pressure.

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Analysis 3.1

Comparison 3 AGI versus diet and exercise, Outcome 1 All‐cause mortality.

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Analysis 3.2

Comparison 3 AGI versus diet and exercise, Outcome 2 Incidence of type 2 diabetes.

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Analysis 3.3

Comparison 3 AGI versus diet and exercise, Outcome 3 Cardiovascular mortality.

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Analysis 3.4

Comparison 3 AGI versus diet and exercise, Outcome 4 Non‐fatal myocardial infarction.

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Analysis 3.5

Comparison 3 AGI versus diet and exercise, Outcome 5 Non‐fatal stroke.

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Analysis 3.6

Comparison 3 AGI versus diet and exercise, Outcome 6 Congestive heart failure.

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Analysis 3.7

Comparison 3 AGI versus diet and exercise, Outcome 7 Non‐serious adverse events.

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Analysis 3.8

Comparison 3 AGI versus diet and exercise, Outcome 8 Fasting plasma glucose.

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Analysis 3.9

Comparison 3 AGI versus diet and exercise, Outcome 9 2‐h glucose measurements.

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Analysis 3.10

Comparison 3 AGI versus diet and exercise, Outcome 10 HbA1c.

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Analysis 3.11

Comparison 3 AGI versus diet and exercise, Outcome 11 Change in total cholesterol.

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Analysis 3.12

Comparison 3 AGI versus diet and exercise, Outcome 12 Change in triglycerides.

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Analysis 3.13

Comparison 3 AGI versus diet and exercise, Outcome 13 Change in HDL‐cholesterol [mmol/L].

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Analysis 3.14

Comparison 3 AGI versus diet and exercise, Outcome 14 Change in body mass index.

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Analysis 3.15

Comparison 3 AGI versus diet and exercise, Outcome 15 Change in diastolic blood pressure.

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Analysis 3.16

Comparison 3 AGI versus diet and exercise, Outcome 16 Change in systolic blood pressure.

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Analysis 4.1

Comparison 4 AGI versus no intervention, Outcome 1 All‐cause mortality.

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Analysis 4.2

Comparison 4 AGI versus no intervention, Outcome 2 Incidence of type 2 diabetes.

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Analysis 4.3

Comparison 4 AGI versus no intervention, Outcome 3 Cardiovascular mortality.

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Analysis 4.4

Comparison 4 AGI versus no intervention, Outcome 4 Non‐fatal myocardial infarction.

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Analysis 4.5

Comparison 4 AGI versus no intervention, Outcome 5 Non‐fatal stroke.

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Analysis 4.6

Comparison 4 AGI versus no intervention, Outcome 6 Congestive heart failure.

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Analysis 4.7

Comparison 4 AGI versus no intervention, Outcome 7 Non‐serious adverse events.

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Analysis 4.8

Comparison 4 AGI versus no intervention, Outcome 8 Hypoglycaemia.

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Analysis 4.9

Comparison 4 AGI versus no intervention, Outcome 9 Fasting plasma glucose.

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Analysis 4.10

Comparison 4 AGI versus no intervention, Outcome 10 2‐h glucose measurements.

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Analysis 4.11

Comparison 4 AGI versus no intervention, Outcome 11 HbA1c.

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Analysis 4.12

Comparison 4 AGI versus no intervention, Outcome 12 Change in total cholesterol.

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Analysis 4.13

Comparison 4 AGI versus no intervention, Outcome 13 Change in HDL‐cholesterol.

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Analysis 4.14

Comparison 4 AGI versus no intervention, Outcome 14 Change in LDL‐cholesterol.

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Analysis 4.15

Comparison 4 AGI versus no intervention, Outcome 15 Change in triglycerides.

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Analysis 4.16

Comparison 4 AGI versus no intervention, Outcome 16 Change in body weight.

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Analysis 4.17

Comparison 4 AGI versus no intervention, Outcome 17 Change in body mass index.

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Analysis 4.18

Comparison 4 AGI versus no intervention, Outcome 18 Change in diastolic blood pressure.

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Analysis 4.19

Comparison 4 AGI versus no intervention, Outcome 19 Change in systolic blood pressure.

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Summary of findings for the main comparison. Acarbose compared to placebo

Acarbose for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk of developing of type 2 diabetes mellitus
Population: people at risk of developing type 2 diabetes mellitus Settings: outpatients Intervention: alpha‐glucosidase inhibitors (acarbose) Comparison: placebo
Outcomes	Placebo	Acarbose	Relative effect (95% CI)	Number of participants Trials	Certainty of the evidence (GRADE)	Comments
All‐cause mortality Follow‐up: 3‐5 years	56 per 1000	55 per 1000 (44 to 66)	RR 0.98 (0.82 to 1.18)	8069 3 RCTs	⊕⊝⊝⊝ Very low^a	‐
Incidence of T2DM Follow‐up: 3‐5 years Definition of intermediate hyperglycaemia (definition of T2DM incidence): ACE 2017: FPG < 7.0 mmol/L; 2hPG ≥ 7.8 ‐ < 11.1 mmol/L (FPG ≥7.0 mmol/L; 2hPG ≥ 11.1 mmol/L) DAISI 2008: FPG < 7.8 mmol/L; 2hPG 7.8–11.1 mmol/L; HbA1c ≤ 7.0% (FPG ≥ 7.8 mmol/L; 2hPG ≥ 11.1 mmol/L) STOP‐NIDDM 2002: FPG 5.6‐7.7 mmol/L; 2hPG ≥ 7.8 ≤ 11.1 mmol/L (2hPG ≥ 11.1 mmol/L)	203 per 1000	167 per 1000 (152 to 181)	RR 0.82 (0.75 to 0.89) (95% prediction interval: 0.48 to 1.40)	8008 3 RCTs	⊕⊕⊕⊝ Moderate^b	ACE 2017 included participants with coronary heart disease and contributed 64.0% of cases
Serious adverse events Follow‐up: 3.3‐5 years	95 per 1000	106 per 1000 (92 to 122)	RR 1.12 (0.97 to 1.29)	6625 2 RCTs	⊕⊕⊝⊝ Low^c	‐
Cardiovascular mortality Follow‐up: 3.3‐5 years	42 per 1000	37 per 1000 (29 to 46)	RR 0.88 (0.71 to 1.10)	8069 3 RCTs	⊕⊝⊝⊝ Very low^a	‐
(a)Non‐fatal myocardial infarction (b)Non‐fatal stroke (c)Congestive heart failure Follow‐up: 3.3 years	(a) 20 per 1000 (b) 6 per 1000 (c) 19 per 1000	(a) 1 per 1000 (0 to 11) (b) 3 per 1000 (1 to 16) (c) 16 per 1000 (12 to 21)	(a) RR 0.10 (0.02 to 0.53) (b) RR 0.50 (0.09 to 2.74) (c) RR 0.87 (0.63 to 1.12)	(a) 1486 2 RCTs (b) 1368 1 RCT (c) 7890 2 RCTs	(a) ⊕⊝⊝⊝ Very low^d (b) ⊕⊝⊝⊝ Very low^d (c) ⊕⊕⊝⊝ Low^e	‐
Health‐related quality of life	Not reported
Socioeconomic effects	Not reported
The basis for the assumed risk* (e.g. the median control group risk across trials) 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). 2hPG: 2‐hour plasma glucose; CI: confidence interval; FPG: fasting plasma glucose;HbA1c: glycosylated haemoglobin A1c; IGT: impaired glucose tolerance; RCT: randomised controlled trial; RR: risk ratio; T2DM: type 2 diabetes mellitus
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
^aDowngraded by one level because of inconsistency in direction of effect and by two levels because of serious imprecision (confidence interval consistent with benefit and harm and small number of trials). See Appendix 17. ^bDowngraded by one level because of imprecision (small number of trials). See Appendix 17. ^cDowngraded by two levels because of serious imprecision (confidence interval consistent with benefit and harm and small number of trials). See Appendix 17. ^dDowngraded by two levels because of serious risk of bias (attrition bias and reporting bias), and by one level because of imprecision (small number of trials). See Appendix 17. ^eDowngraded by two levels because of serious imprecision (confidence interval consistent with benefit and harm and small number of trials). See Appendix 17.

Summary of findings for the main comparison. Acarbose compared to placebo

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Summary of findings 2. Acarbose compared to no intervention

Acarbose for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk of developing type 2 diabetes mellitus
Population: people at risk of developing type 2 diabetes mellitus Settings: outpatients Intervention: alpha‐glucosidase inhibitors (acarbose) Comparison: no intervention
Outcomes	No intervention	Acarbose	Relative effect (95% CI)	Number of participants Trials	Certainty of the evidence (GRADE)	Comments
All‐cause mortality Follow‐up: 1‐5 years	See comment			171 2 RCTs	⊕⊝⊝⊝ Very low^a	2 of 4 trials reported mortality. No deaths occurred.
Incidence of T2DM Follow‐up: 1‐5 years Definition of intermediate hyperglycaemia (definition of T2DM incidence): Fang 2004 and Wang 2000: FPG < 7.8 mmol/L; 2hPG ≥ 7.8 ≤ 11.1 mmol/L (FPG ≥ 7.8 mmol/L; 2hPG ≥ 11.1 mmol/L)	277 per 1000	86 per 1000 (39 to 191)	RR 0.31 (0.14 to 0.69)	140 2 RCTs	⊕⊝⊝⊝ Very low^b	‐
Serious adverse events	Not reported
Cardiovascular mortality Follow‐up: 1‐4.5 years	49 per 1000	31 per 1000 (8 to 124)	RR 0.64 (0.16 to 2.56)	205 2 RCTs	⊕⊝⊝⊝ Very low^c	‐
(a)Non‐fatal myocardial infarction (b)Non‐fatal stroke (c)Congestive heart failure Follow‐up: 1‐4.5 years	(a) 68 per 1000 (b) 39 per 1000 (c) 58 per 1000	(a) 20 per 1000 (5 to 96) (b) 21 per 1000 (4 to 109) (c) 51per 1000 (16 to 159)	(a) RR 0.30 (0.07 to 1.41) (b) RR 0.53 (0.10 to 2.81) (c) RR 0.87 (0.27 to 2.73)	(a) 205 2 RCTs (b) 205 2 RCTs (c) 205 2 RCTs	(a) ⊕⊝⊝⊝ Very low^c (b) ⊕⊝⊝⊝ Very low^c (c) ⊕⊝⊝⊝ Very low^c	‐
Health‐related quality of life	Not reported
Socioeconomic effects	Not reported
The basis for the assumed risk* (e.g. the median control group risk across trials) 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). 2hPG: 2‐hour plasma glucose; CI: confidence interval; FPG: fasting plasma glucose;HbA1c: glycosylated haemoglobin A1c; RCT: randomised controlled trials; RR: risk ratio; T2DM: type 2 diabetes mellitus
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
^aDowngraded by one level because of risk of bias (unclear selection bias and selective reporting), and by two levels because of serious imprecision (small number of trials, small sample size and the outcome not being a common event). See Appendix 18. ^bDowngraded by one level because of risk of bias (unclear selection bias and selective reporting), and by two levels because of serious imprecision (small number of trials and small sample size). See Appendix 18. ^cDowngraded by one level because of risk of bias (unclear selection bias and selective reporting), and by two levels because of serious imprecision (small number of trials, small sample size and CI consistent with benefit and harm). See Appendix 18.

Summary of findings 2. Acarbose compared to no intervention

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Table 1. Overview of trial populations

Trial ID (design)	Intervention(s) and comparator(s)	Short description of power and sample size calculation	Screened/eligible (N)	Randomised (N)	ITT (N)	Analysed (N)	Finishing trial (N)	Randomised finishing trial (%)	Follow‐up (extended follow‐up)^a
ABC 2017 (parallel RCT)	Intervention 1: voglibose	"Given a hazard ratio (HR) of 0.717 with survival rates of 89% at 24 months in the control group, we estimated the total sample size of 3000 subjects along with 325 events (1500 per group), providing 85% power of one‐sided log‐rank test of 2.5% significance level to detect the assumed reduction, assuming the loss of patients during the follow‐up to be 15%"	‐/870	428	424	424	424	99.1	2 years
	Comparator 1: diet and exercise		‐/870	442	435	435	435	98.4
	total:			870	859	859	859	98.7
ACE 2017(parallel RCT)	Intervention 1: acarbose	"7268 patients were required with 904 adjudicated primary composite cardiovascular end points to achieve 90% power. The population size was reduced from 7500 to 6500, with an estimated 728 confirmed composite primary outcome required to have at least 85% power to detect a 20% risk reduction for acarbose, compared with placebo (two‐sided α=0·05)"	15204/7671	3272	3272	3272	3092	94.5	Median of 5 years
	Comparator 1: placebo		15204/7671	3250	3250	3250	3064	94.3
	total:			6522	6522	6522	6156	94.3
Yun 2016(parallel RCT)	Intervention 1: acarbose	‐	426/135	67	‐	60	60	89.55	1‐4.5 years
	Comparator 1: no intervention	‐	426/135	68	‐	64	64	94.12
	total:			135	‐	124	124	91.85
Koyasu 2010(parallel RCT)	Intervention 1: acarbose	‐	‐/90	45	‐	42	42	93.33	1 year
	Comparator 1: no intervention	‐	‐/90	45	‐	39	39	86.67
	total:			90	‐	81	81	90
Kawamori 2009(parallel RCT)	Intervention 1: voglibose	"Assuming a conversion rate of 7.7% per year, a study duration of 4.9 years, and a drop‐out rate of 5%, the planned sample size was 864 (90% power to detect a 40% reduction in the primary endpoint with a two‐sided type I error of 0·05). Due to greater improvement to normoglycaemia than expected, sample size increased to 1728"	4582/1780	897	‐	897	768	85.62	Until diagnosis of normoglycaemia or diabetes type 2, or at least 3 years
	Comparator 1: placebo		4582/1780	883	‐	881	737	83.47
	total:			1780	‐	1778	1505	84.55
Fang 2004(parallel RCT)	Intervention 1: acarbose	‐	‐/‐	50	‐	45	45	90	5 years
	Comparator 1: no intervention			40	‐	35	35	87.5
	Comparator 2: metformin			48	‐	44	44	91.67
	Comparator 3: diet and exercise			40	‐	36	36	90
	total:			178	‐	160	160	89.89
Wang 2000(parallel RCT)	Intervention 1: acarbose	‐	‐/61	31	‐	30	30	96.77	1 year
	Comparator 1: No intervention	‐	‐/61	30	‐	30	30	100
	total:			61	‐	60	60	98.36
DAISI 2008(parallel RCT)	Intervention 1: acarbose	47 participants in each treatment group with alpha (2‐sided) = 0.05 and beta = 0.05	6651/118	60	60	60	30	50	3 years
	Comparator 1: placebo		6651/118	p8	58	58	36	62.07
	total:			118	118	118	66	55.93
EDIT 1997(factorial RCT)	Intervention 1: acarbose + placebo	‐	‐/631	157	‐	‐	‐	‐	6 years
	Comparator 1: placebo + placebo			159	‐	‐	‐	‐
	Comparator 2: metformin + placebo			160	‐	‐	‐	‐
	Comparator 3: metformin + acarbose			155	‐	‐	‐	‐
	total:			631	‐	‐	522	82.73
STOP‐NIDDM 2002(parallel RCT)	Intervention 1: acarbose	"It was estimated that 600 patients would be required in each treatment group for a 2‐tailed alpha of .05 and a 1‐beta of 90% assuming a conversion rate of 7% per year, a 36% risk reduction, and a drop‐out rate of 10%"	14742/1429	714	682	682	471	65.97	mean 3.3 years
	Comparator 1: placebo		14742/1429	715	686	686	556	77.76
	total:			1429	1368	1368	1027	71.87
Grand total	All interventions			5721			4962 (excl. EDIT 1997)
	All comparators			6093			5076 (excl. EDIT 1997)
	All interventions and comparators			11,814			10,038 (excl. EDIT 1997) 10,560 (incl. EDIT 1997)
‐ denotes not reported; ITT: intention‐to‐treat; RCT: randomised controlled trial ^aFollow‐up under randomised conditions until end of trial ( (= duration of intervention + follow‐up post‐intervention or identical to duration of intervention); extended follow‐up refers to follow‐up of participants once the original trial was terminated as specified in the power calculation.

Table 1. Overview of trial populations

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Comparison 1. AGI versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All‐cause mortality Show forest plot	4	9847	Risk Ratio (M‐H, Random, 95% CI)	1.24 [0.53, 2.90]

1.1 Acarbose	3	8069	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.82, 1.18]
1.2 Voglibose	1	1778	Risk Ratio (M‐H, Random, 95% CI)	12.77 [0.72, 226.31]
2 Incidence of type 2 diabetes Show forest plot	4	9786	Risk Ratio (M‐H, Random, 95% CI)	0.73 [0.59, 0.90]

2.1 Acarbose	3	8008	Risk Ratio (M‐H, Random, 95% CI)	0.82 [0.75, 0.89]
2.2 Voglibose	1	1778	Risk Ratio (M‐H, Random, 95% CI)	0.46 [0.34, 0.64]
3 Serious adverse events Show forest plot	3	8403	Risk Ratio (M‐H, Random, 95% CI)	1.12 [0.97, 1.30]

3.1 Acarbose	2	6625	Risk Ratio (M‐H, Random, 95% CI)	1.12 [0.97, 1.29]
3.2 Voglibose	1	1778	Risk Ratio (M‐H, Random, 95% CI)	2.46 [0.48, 12.62]
4 Cardiovascular mortality Show forest plot	4	9847	Risk Ratio (M‐H, Random, 95% CI)	0.89 [0.72, 1.10]

4.1 Acarbose	3	8069	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.71, 1.10]
4.2 Voglibose	1	1778	Risk Ratio (M‐H, Random, 95% CI)	2.95 [0.12, 72.23]
5 Non‐fatal myocardial infarction Show forest plot	2	1486	Risk Ratio (M‐H, Random, 95% CI)	0.10 [0.02, 0.53]

6 Non‐fatal stroke Show forest plot	1	1368	Risk Ratio (M‐H, Random, 95% CI)	0.50 [0.09, 2.74]

7 Congestive heart failure Show forest plot	2	7890	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.63, 1.21]

8 Non‐serious adverse events Show forest plot	3	3328	Risk Ratio (M‐H, Random, 95% CI)	1.04 [1.02, 1.06]

8.1 Acarbose	2	1550	Risk Ratio (M‐H, Random, 95% CI)	1.04 [1.01, 1.06]
8.2 Voglibose	1	1778	Risk Ratio (M‐H, Random, 95% CI)	1.06 [1.02, 1.10]
9 Hypoglycaemia Show forest plot	1	6522	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.89, 1.14]

10 Fasting plasma glucose Show forest plot	3	7368	Mean Difference (IV, Random, 95% CI)	‐0.07 [‐0.12, ‐0.02]

11 2‐h glucose measurements Show forest plot	3	6498	Mean Difference (IV, Random, 95% CI)	‐0.53 [‐0.92, ‐0.14]

12 HbA1c Show forest plot	3	6833	Mean Difference (IV, Random, 95% CI)	‐0.08 [‐0.12, ‐0.05]

13 Change in total cholesterol Show forest plot	3	6815	Mean Difference (IV, Random, 95% CI)	‐0.05 [‐0.10, 0.00]

14 Change in HDL‐cholesterol Show forest plot	3	6807	Mean Difference (IV, Random, 95% CI)	0.01 [‐0.00, 0.03]

15 Change in LDL‐cholesterol Show forest plot	3	6699	Mean Difference (IV, Random, 95% CI)	‐0.03 [‐0.07, 0.01]

16 Change in triglycerides Show forest plot	3	6843	Mean Difference (IV, Random, 95% CI)	‐0.07 [‐0.17, 0.03]

17 Change in body weight Show forest plot	2	6959	Mean Difference (IV, Random, 95% CI)	‐0.67 [‐1.57, 0.23]

18 Change in body mass index Show forest plot	2	6953	Mean Difference (IV, Random, 95% CI)	‐0.18 [‐0.39, 0.03]

19 Change in diastolic blood pressure Show forest plot	2	7452	Mean Difference (IV, Random, 95% CI)	‐0.29 [‐0.78, 0.21]

20 Change in systolic blood pressure Show forest plot	2	7452	Mean Difference (IV, Random, 95% CI)	‐0.47 [‐1.26, 0.32]

Comparison 1. AGI versus placebo

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Comparison 2. AGI versus metformin

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All‐cause mortality Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Incidence of type 2 diabetes Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3 Fasting plasma glucose Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4 2‐h glucose measurements Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5 Change in total cholesterol Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

6 Change in triglycerides Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

7 Change in body mass index Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

8 Change in diastolic blood pressure Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

9 Change in systolic blood pressure Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

Comparison 2. AGI versus metformin

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Comparison 3. AGI versus diet and exercise

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All‐cause mortality Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

1.1 Acarbose	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.2 Voglibose	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Incidence of type 2 diabetes Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3 Cardiovascular mortality Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4 Non‐fatal myocardial infarction Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

5 Non‐fatal stroke Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

6 Congestive heart failure Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

7 Non‐serious adverse events Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

8 Fasting plasma glucose Show forest plot	2	509	Mean Difference (IV, Random, 95% CI)	‐1.33 [‐2.15, ‐0.51]

8.1 Acarbose	1	81	Mean Difference (IV, Random, 95% CI)	‐1.37 [‐2.24, ‐0.50]
8.2 Voglibose	1	428	Mean Difference (IV, Random, 95% CI)	‐1.0 [‐3.44, 1.44]
9 2‐h glucose measurements Show forest plot	2	472	Mean Difference (IV, Random, 95% CI)	‐2.74 [‐3.74, ‐1.74]

9.1 Acarbose	1	81	Mean Difference (IV, Random, 95% CI)	‐2.79 [‐3.79, ‐1.79]
9.2 Voglibose	1	391	Mean Difference (IV, Random, 95% CI)	0.7 [‐7.53, 8.93]
10 HbA1c Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

11 Change in total cholesterol Show forest plot	2	586	Mean Difference (IV, Random, 95% CI)	‐0.49 [‐1.32, 0.33]

11.1 Acarbose	1	81	Mean Difference (IV, Random, 95% CI)	‐0.50 [‐1.33, 0.33]
11.2 Voglibose	1	505	Mean Difference (IV, Random, 95% CI)	0.0 [‐6.47, 6.47]
12 Change in triglycerides Show forest plot	2	612	Mean Difference (IV, Random, 95% CI)	‐0.10 [‐0.76, 0.56]

12.1 Acarbose	1	81	Mean Difference (IV, Random, 95% CI)	‐0.10 [‐0.76, 0.56]
12.2 Voglibose	1	531	Mean Difference (IV, Random, 95% CI)	‐0.1 [‐17.03, 16.83]
13 Change in HDL‐cholesterol [mmol/L] Show forest plot	1	545	Mean Difference (IV, Random, 95% CI)	0.0 [‐2.51, 2.51]

14 Change in body mass index Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

15 Change in diastolic blood pressure Show forest plot	2	667	Mean Difference (IV, Random, 95% CI)	1.25 [‐1.65, 4.15]

16 Change in systolic blood pressure Show forest plot	2	668	Mean Difference (IV, Random, 95% CI)	‐1.94 [‐8.71, 4.83]

16.1 Acarbose	1	81	Mean Difference (IV, Random, 95% CI)	‐6.00 [‐12.23, 0.23]
16.2 Voglibose	1	587	Mean Difference (IV, Random, 95% CI)	1.0 [‐1.92, 3.92]

Comparison 3. AGI versus diet and exercise

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Comparison 4. AGI versus no intervention

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All‐cause mortality Show forest plot	2	171	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

2 Incidence of type 2 diabetes Show forest plot	2	140	Risk Ratio (M‐H, Random, 95% CI)	0.31 [0.14, 0.69]

3 Cardiovascular mortality Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4 Non‐fatal myocardial infarction Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

5 Non‐fatal stroke Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

6 Congestive heart failure Show forest plot	2	205	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.27, 2.73]

7 Non‐serious adverse events Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

8 Hypoglycaemia Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

9 Fasting plasma glucose Show forest plot	3	285	Mean Difference (IV, Random, 95% CI)	‐0.35 [‐0.79, 0.08]

10 2‐h glucose measurements Show forest plot	3	285	Mean Difference (IV, Random, 95% CI)	‐2.50 [‐4.18, ‐0.83]

11 HbA1c Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Subtotals only

12 Change in total cholesterol Show forest plot	3	285	Mean Difference (IV, Random, 95% CI)	‐0.32 [‐0.74, 0.10]

13 Change in HDL‐cholesterol Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

14 Change in LDL‐cholesterol Show forest plot	2	205	Mean Difference (IV, Random, 95% CI)	‐0.03 [‐0.22, 0.15]

15 Change in triglycerides Show forest plot	3	285	Mean Difference (IV, Random, 95% CI)	‐0.22 [‐0.40, ‐0.05]

16 Change in body weight Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

17 Change in body mass index Show forest plot	3	285	Mean Difference (IV, Random, 95% CI)	‐0.65 [‐1.01, ‐0.30]

18 Change in diastolic blood pressure Show forest plot	3	285	Mean Difference (IV, Random, 95% CI)	‐0.26 [‐3.80, 3.28]

19 Change in systolic blood pressure Show forest plot	3	285	Mean Difference (IV, Random, 95% CI)	‐3.68 [‐6.46, ‐0.90]

Comparison 4. AGI versus no intervention

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