Table 1—

Characteristics of 41 randomized controlled trials of at least 12 weeks’ duration, comparing AGIs with any other intervention

Ref.Design,* location, settingDuration (weeks)RandomizationAllocation concealmentBlindingHandling of dropoutsPatients randomized (n)Mean age (years)Female (%)Mean duration diabetes (months)Interventions
16Germany, GP24BBAB15260.541.916.5ACA 100 mg t.i.d., PLA
17Scotland, OP16BBBB2858.730.048.0ACA max. 200–100–200 mg (decreased with intolerance), PLA
18Spain, OP16BBAB40NDNDNDACA 100 mg t.i.d., PLA
19United Kingdom, GP156ABAB78962.034.938.1ACA 50 mg t.i.d., ACA 100 mg t.i.d., PLA
20Asia, OP24BBAA12653.449.228.8ACA 100 mg t.i.d., PLA
21Canada, OP52BBBB77§57.237.762.4ACA max 200 mg t.i.d. (titrated), PLA
22Canada, OP36BBAA32458.125.955.0MIG 100 mg t.i.d., metformin 500 mg t.i.d., PLA (combination of MIG and metformin)
23U.S., OP24AAAA21255.85065.5ACA max 300 mg t.i.d. (titrated), PLA
24U.S., OP24AAAA29056.55170.9ACA 200 mg t.i.d., tolbutamide max 1,000 mg t.i.d. (titrated), PLA (combination ACA and tolbutamide)
25U.S., OP16AAAB29055.44366ACA 100 mg t.i.d., ACA 200 mg t.i.d., ACA 300 mg t.i.d., PLA
26Russia, OP24BBBB18051.062.1NDACA 100 mg t.i.d., PLA
27Switzerland, OP16BBBB17ND30.026ACA 50 mg b.i.d., PLA
28The Netherlands, GP/“study centres”24BAAB59963.445.140.0MIG 25 mg t.i.d., MIG 50 mg t.i.d., MIG 100 mg t.i.d., MIG 200 mg t.i.d., PLA
29Europe, OP24AAAB49556.647.121.7ACA 25 mg t.i.d., ACA 50 mg t.i.d., ACA 100 mg t.i.d., ACA 200 mg t.i.d., PLA
30No blinding, Germany, OP24ABA9661.558.926.5ACA 100 mg t.i.d., glibenclamide max 3.5 mg t.i.d. (titrated)
31Crossover, Italy, OP12BBBB76ND76.7110.4ACA 100 mg t.i.d., PLA
32Germany, OP16BBBB7758.748.180.0ACA 100 mg t.i.d., glibenclamide 1 mg t.i.d., PLA
33Germany, OP24AAAA10059.548.959.5ACA 100 mg t.i.d., PLA
34Crossover, Germany, OP12BBBB18NDNDNDACA 200 mg b.i.d., MIG 200 mg b.i.d., glibenclamide 7 mg q.d.
35Single blind (for glibenclamide), Germany, OP24AAAB9658.555.314.0ACA 100 mg t.i.d., glibenclamide max 3.5 mg t.i.d. (titrated)
36Single blind (for metformin), Germany, OP24AAAA9658.466.035.1ACA 100 mg t.i.d., metformin 850 mg b.i.d., PLA
37England, OP156AAAB256§60.528.987.2ACA 100 mg t.i.d. (decreased in case of intolerance), PLA
38Germany/ France/ Spain, OP24AAAA17962.435.258.5ACA 100 mg t.i.d. (decreased in case of intolerance), nateglinide 120 mg t.i.d.
39Japan, OP24BAAB4048.924.356.4ACA 100 mg t.i.d., PLA
40U.S., OP56BBAA41167.832.464.4MIG 25 mg t.i.d., MIG 50 mg t.i.d., glyburide max 20 mg q.d. (titrated), PLA
41U.S., OP52BBBB69§NDNDNDMIG max. 200 mg t.i.d. (decreased in case of intolerance), PLA
42U.S., OP28BBBA45§56.642.249.6MIG 100 mg t.i.d. (decreased in case of intolerance), PLA
43Japan, setting unclear12BBBB445NDNDNDMIG 50 mg t.i.d., VOG 0.2 mg t.i.d., PLA
44Single blind (for glibenclamide), OP24BAAA10257.853.954ACA 100 mg t.i.d., glibenclamide max. 3.5 mg t.i.d. (titrated), PLA
45Canada, OP52BBBA19270.034.963.4ACA max. 100 mg t.i.d. (titrated), PLA
46Canada, OP24BAAA10058.040.671.8MIG 100 mg t.i.d., glibenclamide mg b.i.d. (+1 PLA)
47No blinding, Germany, GP24ABB7657.5ND27.7ACA 100 mg t.i.d., glibenclamide max. 10.5 mg in two doses (titrated)
48Europe, setting unclear24BBBB603NDNDNDACA 100 mg t.i.d., MIG 50 mg t.i.d., MIG 100 mg t.i.d., PLA
49No blinding, Turkey, OP24AAB7254.442.153.6ACA max. 100 mg t.i.d. (may be reduced), gliclazide 80 mg b.i.d. (in general, max. dose not recommended)
50Italy, OP16ABBB8455.835.951.5ACA 50 mg t.i.d., ACA 100 mg t.i.d., PLA
51New Zealand/Australia, OP16BAAB10556.53623.5ACA 100 mg t.i.d. (decreased in case of intolerance), PLA
52Europe, OP24BBAB20158.742NDMIG 100 mg t.i.d., glibenclamide 3.5 mg q.d. (or b.i.d. when hypoglycemia was unacceptable)
53No blinding, Germany, OP24ABB7259.560NDACA 100 mg t.i.d., glibenclamide max. 3.5 mg (titrated)
54No blinding, Japan, OP12BBB3650.5280VOG 0.3 mg t.i.d., glyburide 1.25 mg q.d., diet therapy
55The Netherlands, GP30AAAB9658.6480ACA max. 100 mg t.i.d. (titrated), tolbutamide max. 2,000 mg in 3 doses (titrated)
56China, OP24BBBA7749.34849.8ACA 100 mg t.i.d., PLA
  • *

    * Except when indicated, all studies were parallel and double blind.

  • A, adequate; B, inadequate, unclear.

  • All values except these are based on all randomized patients.

  • §

    § Subgroup of patients treated with diet only.

  • Based on proportion of patients in analysis; number of patients randomized in diet-only group not reported. ACA, acarbose; GP, general practice; MIG, miglitol; ND, no available data; OP, outpatient; PLA, placebo; VOG, voglibose.