Main characteristics of clinical trials included in the meta-analysis
| Study (11)* . | Characteristics . | Comparator . | Duration (weeks) . | Number R/C . | Mean age (years) . | Mean A1C (%) . | Incident cases of cancer R/C . |
|---|---|---|---|---|---|---|---|
| Nondiabetic subjects | |||||||
| Trials on GSK Web site | |||||||
| 100684 | Metabolic syndrome | Placebo | 52 | 43/47 | 45 | — | 0/0 |
| 49653/330 | Plaque psoriasis | Placebo | 52 | 1,181/382 | 44 | — | 3/1 |
| 49653/331 | Plaque psoriasis | Placebo | 52 | 706/325 | 45 | — | 0/1 |
| 49653/334 | Insulin resistant | Placebo | 52 | 178/177 | 68 | — | 4/3 |
| 49653/392 | Insulin resistant | Metformin | 52 | 16/15 | 56 | — | 0/0 |
| 49653/131 | Insulin resistant | Placebo | 26 | 39,427 | 48 | — | 0/0 |
| 49653/452 | Multiple sclerosis | Placebo | 26 | 26/25 | 42 | — | 0/1 |
| ARA102198 | Rheumatoid arthritis | Placebo | 26 | 49/49 | 56 | — | 0/0 |
| AVA100193 | Alzheimer's disease | Placebo | 24 | 394/124 | 71 | — | 0/0 |
| Other published trials | |||||||
| Carr | HIV infection | Placebo | 48 | 53/55 | 45 | — | 1/0 |
| Sidhu | Coronary artery disease | Placebo | 48 | 46/46 | 62 | — | 0/0 |
| Silic | HIV infection | Metformin | 48 | 30/30 | 42 | — | 0/0 |
| van Wijk | HIV infection | Metformin | 26 | 19/20 | 47 | — | 0/0 |
| Coll | HIV infection | Metformin | 26 | 15/16 | 48 | — | 0/0 |
| Cavalcanti | HIV infection | Placebo | 24 | 48/48 | 47 | — | 0/0 |
| Baillargeon | PCOS | Placebo | 24 | 42/30 | 27 | — | 0/0 |
| Lemay | PCOS | None | 24 | 15/13 | 24 | — | 0/0 |
| Type 2 diabetic patients | |||||||
| Trials on GSK Web site | |||||||
| 49653/048 (ADOPT)† | Monotherapy | Glyburide | 208 | 1,456/1,441 | 56 | 7.3 | 63/71 |
| 49653/048 (ADOPT)† | Monotherapy | Metformin | 208 | 1,456/1,454 | 57 | 7.3 | 63/67 |
| 49653/080 | Monotherapy | Glyburide | 156 | 104/99 | 56 | 9.1 | 1/3 |
| 49653/097 | Monotherapy | Glyburide | 148 | 122/120 | 56 | 8.9 | 1/4 |
| 49653/135 | Combined therapy | Placebo | 104 | 116/111 | 68 | 7.4 | 4/7 |
| 49653/211 | NYHA-II, mono-combined | Placebo | 52 | 110/114 | 64 | NR | 2/3 |
| 49653/020 | Monotherapy | Glyburide | 52 | 384/203 | 60 | 8.2 | 3/0 |
| AVM100264 | Combined therapy | Sulfonylureas | 52 | 294/302 | 59 | 8.0 | 2/1 |
| 712753/008 | Combined therapy | None | 48 | 284/135 | 55 | NR | 3/0 |
| 49653/137 | Combined therapy | Glyburide | 32 | 204/185 | 59 | 8.4 | 2/4 |
| BRL49653/185 | Mono-combined | None | 32 | 563/142 | 59 | 7.4 | 4/2 |
| SB-712753/003 | Combined therapy | Placebo | 32 | 254/272 | 59 | 7.2 | 0/1 |
| SB-712753/007† | Monotherapy, OL | Metformin | 32 | 159/154 | 59 | 7.2 | 0/0 |
| SB-712753/007† | Combined therapy, OL | None | 32 | 155/154 | 59 | 7.2 | 0/0 |
| 49653/128 | Combined therapy | Placebo | 28 | 39/38 | 58 | 9.6 | 0/0 |
| 49653/134 | Combined therapy | Placebo | 28 | 561/276 | 55 | 8.7 | 0/2 |
| SB-797620/004 | Monotherapy | Glimepiride | 28 | 232/225 | 53 | 9.0 | 1/0 |
| 49653/024 | Monotherapy | Placebo | 26 | 774/185 | 57 | 8.9 | 5/1 |
| 49653/044 | Combined therapy | Placebo | 26 | 71/34 | 54 | 9.6 | 0/0 |
| 49653/079 | Monotherapy | Glyburide | 26 | 104/106 | 58 | 9.2 | 1/0 |
| 49653/079 | Combined therapy | Placebo | 26 | 99/106 | 58 | 9.2 | 2/0 |
| 49653/082 | Combined therapy | Placebo | 26 | 212/107 | 56 | 9.1 | 0/0 |
| 49653/085 | Combined therapy | Placebo | 26 | 138/139 | 61 | NR | 1/0 |
| 49653/093† | Monotherapy | Metformin | 26 | 107/109 | 59 | 8.7 | 0/0 |
| 49653/093† | Combined therapy | Placebo | 26 | 106/109 | 59 | 8.7 | 0/0 |
| 49653/094 | Combined therapy | Placebo | 26 | 232/116 | 58 | 8.8 | 0/0 |
| 49653/095 | Combined therapy | Placebo | 26 | 196/96 | 58 | 9.0 | 1/0 |
| 49653/096 | Combined therapy | Placebo | 26 | 232/115 | 60 | 9.1 | 2/0 |
| 49653/109 | Monotherapy | Glipizide | 26 | 52/25 | 53 | 8.0 | 0/0 |
| 49653/125 | Combined therapy, OL | None | 26 | 175/173 | 56 | 8.9 | 0/0 |
| 49653/127 | Combined therapy | Placebo | 26 | 56/58 | 60 | 9.0 | 0/2 |
| 49653/136 | Combined therapy | Placebo | 26 | 148/143 | 65 | 8.2 | 2/0 |
| 49653/145 | Combined therapy | None | 26 | 231/242 | 61 | 8.6 | 1/0 |
| 49653/147 | Combined therapy | Placebo | 26 | 89/88 | 54 | 9.1 | 0/0 |
| 49653/162 | Combined therapy | Placebo | 26 | 168/172 | 60 | 8.0 | 2/0 |
| 49653/234 | Combined therapy | Placebo | 26 | 116/61 | 63 | 8.1 | 1/0 |
| 49653/390 | Combined therapy | None | 26 | 33/30 | NR | NR | 1/0 |
| 49653/369 | Monotherapy | Glyburide | 26 | 25/24 | 52 | 6.8 | 0/0 |
| 49653/132 | Combined therapy | Placebo | 24 | 442/112 | 59 | 9.8 | 1/1 |
| 49653/347 | Combined therapy | Placebo | 24 | 418/212 | 53 | 9.0 | 0/1 |
| 49653/015 | Combined therapy | Placebo | 24 | 395/198 | 61 | 9.2 | 4/0 |
| 49653/284 | Combined therapy | Placebo | 24 | 382/384 | 55 | 8.0 | 1/0 |
| SB-712753/002 | Combined therapy | Placebo | 24 | 288/280 | 58 | 7.5 | 1/0 |
| 49653/090 | Monotherapy | Placebo | 24 | 228/75 | 59 | 8.8 | 1/0 |
| 49653/325 | Combined therapy | Placebo | 24 | 196/195 | 53 | 8.0 | 0/1 |
| SB-712753/009 | Combined therapy | Placebo | 24 | 162/160 | 57 | 8.7 | 2/0 |
| AVD102209 | Combined therapy | Placebo | 24 | 132/131 | 56 | 9.6 | 0/0 |
| 49653/143 | Combined therapy | Placebo | 24 | 121/124 | 52 | 9.2 | 1/0 |
| 49653/207 | Children monotherapy | Metformin | 24 | 99/101 | 14 | 8.0 | 0/0 |
| 49653/282 | Combined therapy | Glyburide | 24 | 69/72 | 60 | 7.6 | 0/0 |
| Other published trials | |||||||
| Ko | Combined therapy | Insulin | 52 | 56/56 | 58 | 9.6 | 0/0 |
| Derosa (a) | Combined therapy | Glimepiride | 52 | 49/50 | 53 | 8.0 | 0/0 |
| Derosa (b) | Combined therapy | Pioglitazone | 52 | 48/48 | 55 | 9.0 | 0/0 |
| Derosa (c) | Monotherapy | Pioglitazone | 52 | 45/42 | 54 | 8.1 | 0/0 |
| Rahman | Monotherapy | Placebo | 52 | 11/11 | 47 | 7.5 | 0/0 |
| Kelly | Combined therapy | Glyburide | 26 | 20/16 | 60 | 7.6 | 0/0 |
| Reynolds | Monotherapy | Placebo | 26 | 8/10 | 49 | 9.2 | 0/0 |
| Osman | Monotherapy, PTCA | Placebo | 26 | 8/8 | 55 | 9.6 | 0/0 |
| Zhou | Combined therapy | Placebo | 24 | 442/112 | 56 | 9.8 | 0/0 |
| Goldberg | Monotherapy | Pioglitazone | 24 | 369/366 | 56 | 7.5 | 0/0 |
| Weissman | Combined therapy | Placebo | 24 | 358/351 | 55 | 8.0 | 0/0 |
| Agrawal | Combined therapy | None | 24 | 288/280 | 58 | 7.5 | 0/0 |
| Dailey | Combined therapy | Placebo | 24 | 181/184 | 57 | 8.1 | 0/1 |
| Garber | Combined therapy | Glyburide | 24 | 158/160 | 56 | 8.5 | 0/0 |
| Wang | Mono-combined | None | 24 | 35/35 | 61 | 7.3 | 0/0 |
| Wong | Combined therapy | None | 24 | 26/26 | 62 | 7.2 | 0/0 |
| Jung | Combined therapy | Metformin | 24 | 15/15 | 57 | 9.1 | 0/0 |
| Total | — | — | 39.2 | 16,332/12,522 | 55.3 | 8.1 | 124/178 |
| Study (11)* . | Characteristics . | Comparator . | Duration (weeks) . | Number R/C . | Mean age (years) . | Mean A1C (%) . | Incident cases of cancer R/C . |
|---|---|---|---|---|---|---|---|
| Nondiabetic subjects | |||||||
| Trials on GSK Web site | |||||||
| 100684 | Metabolic syndrome | Placebo | 52 | 43/47 | 45 | — | 0/0 |
| 49653/330 | Plaque psoriasis | Placebo | 52 | 1,181/382 | 44 | — | 3/1 |
| 49653/331 | Plaque psoriasis | Placebo | 52 | 706/325 | 45 | — | 0/1 |
| 49653/334 | Insulin resistant | Placebo | 52 | 178/177 | 68 | — | 4/3 |
| 49653/392 | Insulin resistant | Metformin | 52 | 16/15 | 56 | — | 0/0 |
| 49653/131 | Insulin resistant | Placebo | 26 | 39,427 | 48 | — | 0/0 |
| 49653/452 | Multiple sclerosis | Placebo | 26 | 26/25 | 42 | — | 0/1 |
| ARA102198 | Rheumatoid arthritis | Placebo | 26 | 49/49 | 56 | — | 0/0 |
| AVA100193 | Alzheimer's disease | Placebo | 24 | 394/124 | 71 | — | 0/0 |
| Other published trials | |||||||
| Carr | HIV infection | Placebo | 48 | 53/55 | 45 | — | 1/0 |
| Sidhu | Coronary artery disease | Placebo | 48 | 46/46 | 62 | — | 0/0 |
| Silic | HIV infection | Metformin | 48 | 30/30 | 42 | — | 0/0 |
| van Wijk | HIV infection | Metformin | 26 | 19/20 | 47 | — | 0/0 |
| Coll | HIV infection | Metformin | 26 | 15/16 | 48 | — | 0/0 |
| Cavalcanti | HIV infection | Placebo | 24 | 48/48 | 47 | — | 0/0 |
| Baillargeon | PCOS | Placebo | 24 | 42/30 | 27 | — | 0/0 |
| Lemay | PCOS | None | 24 | 15/13 | 24 | — | 0/0 |
| Type 2 diabetic patients | |||||||
| Trials on GSK Web site | |||||||
| 49653/048 (ADOPT)† | Monotherapy | Glyburide | 208 | 1,456/1,441 | 56 | 7.3 | 63/71 |
| 49653/048 (ADOPT)† | Monotherapy | Metformin | 208 | 1,456/1,454 | 57 | 7.3 | 63/67 |
| 49653/080 | Monotherapy | Glyburide | 156 | 104/99 | 56 | 9.1 | 1/3 |
| 49653/097 | Monotherapy | Glyburide | 148 | 122/120 | 56 | 8.9 | 1/4 |
| 49653/135 | Combined therapy | Placebo | 104 | 116/111 | 68 | 7.4 | 4/7 |
| 49653/211 | NYHA-II, mono-combined | Placebo | 52 | 110/114 | 64 | NR | 2/3 |
| 49653/020 | Monotherapy | Glyburide | 52 | 384/203 | 60 | 8.2 | 3/0 |
| AVM100264 | Combined therapy | Sulfonylureas | 52 | 294/302 | 59 | 8.0 | 2/1 |
| 712753/008 | Combined therapy | None | 48 | 284/135 | 55 | NR | 3/0 |
| 49653/137 | Combined therapy | Glyburide | 32 | 204/185 | 59 | 8.4 | 2/4 |
| BRL49653/185 | Mono-combined | None | 32 | 563/142 | 59 | 7.4 | 4/2 |
| SB-712753/003 | Combined therapy | Placebo | 32 | 254/272 | 59 | 7.2 | 0/1 |
| SB-712753/007† | Monotherapy, OL | Metformin | 32 | 159/154 | 59 | 7.2 | 0/0 |
| SB-712753/007† | Combined therapy, OL | None | 32 | 155/154 | 59 | 7.2 | 0/0 |
| 49653/128 | Combined therapy | Placebo | 28 | 39/38 | 58 | 9.6 | 0/0 |
| 49653/134 | Combined therapy | Placebo | 28 | 561/276 | 55 | 8.7 | 0/2 |
| SB-797620/004 | Monotherapy | Glimepiride | 28 | 232/225 | 53 | 9.0 | 1/0 |
| 49653/024 | Monotherapy | Placebo | 26 | 774/185 | 57 | 8.9 | 5/1 |
| 49653/044 | Combined therapy | Placebo | 26 | 71/34 | 54 | 9.6 | 0/0 |
| 49653/079 | Monotherapy | Glyburide | 26 | 104/106 | 58 | 9.2 | 1/0 |
| 49653/079 | Combined therapy | Placebo | 26 | 99/106 | 58 | 9.2 | 2/0 |
| 49653/082 | Combined therapy | Placebo | 26 | 212/107 | 56 | 9.1 | 0/0 |
| 49653/085 | Combined therapy | Placebo | 26 | 138/139 | 61 | NR | 1/0 |
| 49653/093† | Monotherapy | Metformin | 26 | 107/109 | 59 | 8.7 | 0/0 |
| 49653/093† | Combined therapy | Placebo | 26 | 106/109 | 59 | 8.7 | 0/0 |
| 49653/094 | Combined therapy | Placebo | 26 | 232/116 | 58 | 8.8 | 0/0 |
| 49653/095 | Combined therapy | Placebo | 26 | 196/96 | 58 | 9.0 | 1/0 |
| 49653/096 | Combined therapy | Placebo | 26 | 232/115 | 60 | 9.1 | 2/0 |
| 49653/109 | Monotherapy | Glipizide | 26 | 52/25 | 53 | 8.0 | 0/0 |
| 49653/125 | Combined therapy, OL | None | 26 | 175/173 | 56 | 8.9 | 0/0 |
| 49653/127 | Combined therapy | Placebo | 26 | 56/58 | 60 | 9.0 | 0/2 |
| 49653/136 | Combined therapy | Placebo | 26 | 148/143 | 65 | 8.2 | 2/0 |
| 49653/145 | Combined therapy | None | 26 | 231/242 | 61 | 8.6 | 1/0 |
| 49653/147 | Combined therapy | Placebo | 26 | 89/88 | 54 | 9.1 | 0/0 |
| 49653/162 | Combined therapy | Placebo | 26 | 168/172 | 60 | 8.0 | 2/0 |
| 49653/234 | Combined therapy | Placebo | 26 | 116/61 | 63 | 8.1 | 1/0 |
| 49653/390 | Combined therapy | None | 26 | 33/30 | NR | NR | 1/0 |
| 49653/369 | Monotherapy | Glyburide | 26 | 25/24 | 52 | 6.8 | 0/0 |
| 49653/132 | Combined therapy | Placebo | 24 | 442/112 | 59 | 9.8 | 1/1 |
| 49653/347 | Combined therapy | Placebo | 24 | 418/212 | 53 | 9.0 | 0/1 |
| 49653/015 | Combined therapy | Placebo | 24 | 395/198 | 61 | 9.2 | 4/0 |
| 49653/284 | Combined therapy | Placebo | 24 | 382/384 | 55 | 8.0 | 1/0 |
| SB-712753/002 | Combined therapy | Placebo | 24 | 288/280 | 58 | 7.5 | 1/0 |
| 49653/090 | Monotherapy | Placebo | 24 | 228/75 | 59 | 8.8 | 1/0 |
| 49653/325 | Combined therapy | Placebo | 24 | 196/195 | 53 | 8.0 | 0/1 |
| SB-712753/009 | Combined therapy | Placebo | 24 | 162/160 | 57 | 8.7 | 2/0 |
| AVD102209 | Combined therapy | Placebo | 24 | 132/131 | 56 | 9.6 | 0/0 |
| 49653/143 | Combined therapy | Placebo | 24 | 121/124 | 52 | 9.2 | 1/0 |
| 49653/207 | Children monotherapy | Metformin | 24 | 99/101 | 14 | 8.0 | 0/0 |
| 49653/282 | Combined therapy | Glyburide | 24 | 69/72 | 60 | 7.6 | 0/0 |
| Other published trials | |||||||
| Ko | Combined therapy | Insulin | 52 | 56/56 | 58 | 9.6 | 0/0 |
| Derosa (a) | Combined therapy | Glimepiride | 52 | 49/50 | 53 | 8.0 | 0/0 |
| Derosa (b) | Combined therapy | Pioglitazone | 52 | 48/48 | 55 | 9.0 | 0/0 |
| Derosa (c) | Monotherapy | Pioglitazone | 52 | 45/42 | 54 | 8.1 | 0/0 |
| Rahman | Monotherapy | Placebo | 52 | 11/11 | 47 | 7.5 | 0/0 |
| Kelly | Combined therapy | Glyburide | 26 | 20/16 | 60 | 7.6 | 0/0 |
| Reynolds | Monotherapy | Placebo | 26 | 8/10 | 49 | 9.2 | 0/0 |
| Osman | Monotherapy, PTCA | Placebo | 26 | 8/8 | 55 | 9.6 | 0/0 |
| Zhou | Combined therapy | Placebo | 24 | 442/112 | 56 | 9.8 | 0/0 |
| Goldberg | Monotherapy | Pioglitazone | 24 | 369/366 | 56 | 7.5 | 0/0 |
| Weissman | Combined therapy | Placebo | 24 | 358/351 | 55 | 8.0 | 0/0 |
| Agrawal | Combined therapy | None | 24 | 288/280 | 58 | 7.5 | 0/0 |
| Dailey | Combined therapy | Placebo | 24 | 181/184 | 57 | 8.1 | 0/1 |
| Garber | Combined therapy | Glyburide | 24 | 158/160 | 56 | 8.5 | 0/0 |
| Wang | Mono-combined | None | 24 | 35/35 | 61 | 7.3 | 0/0 |
| Wong | Combined therapy | None | 24 | 26/26 | 62 | 7.2 | 0/0 |
| Jung | Combined therapy | Metformin | 24 | 15/15 | 57 | 9.1 | 0/0 |
| Total | — | — | 39.2 | 16,332/12,522 | 55.3 | 8.1 | 124/178 |
See Appendix for references.
Trials with multiple comparators. ADOPT, A Diabetes Outcome Progression Trial; mono-combined, monotherapy or combined therapy; NR, not reported; NYHA-II, New York Heart Association, Class II; OL, open label; PCOS, polycystic ovary syndrome; PTCA, percutaneous transluminal coronary angioplasty; R/C, rosiglitazone versus comparator.