Table 1 Study characteristics.
Study ID | Total number of patients | Metformin plus PPAR agonist arm | Metformin alone arm | Metformin dose | PPAR agonist | PPAR agonist dose | Mean age (MET/MET + PPAR) | Gender (Male/Female) | Location of trial | Single/Multicenter trial | Number of study arms | Study duration (weeks) | Primary outcome | A priori sample size calculations reported | Funding source |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bailey et al.37 | 569 | 289 | 280 | 2500 mg/day | Rosiglitazone | 4 mg/day | 57.6/58.1 | 327/241 | Europe | Multicenter | 2 arms | 24 | Hemoglobin A1c | Yes | GlaxoSmithKline |
Borges et al.38 | 688 | 348 | 340 | 2000 mg/d | Rosiglitazone | 4 mg/day | 50.7/51.5 | 360/318 | Global | Multicenter | 2 arms | 80 | Hemoglobin A1c | Yes | GlaxoSmithKline |
Derosa et al.39 | 136 | 69 | 67 | 3000 mg/d | Pioglitazone | 45 mg/day | 55/57 | 68/68 | Italy | Multicenter | 4 arms enrolled, 2 included in SR | 64 | BMI, HbA1c, FPG, PPG, FPI, PPI, GIR, and TGR | Yes | Not reported |
Einhorn et al.40 | 328 | 168 | 160 | stable dose for 30 days | Pioglitazone | 30 mg/day | 55.7/55.5 | 188/140 | United States | Multicenter | 2 arms | 16 | Not reported | Not reported | Takeda |
Fonseca et al.41 | 348 | 119 | 116 | 2500 mg/day | Rosiglitazone | 4 mg/day | 58.8/57.5 | 231 /108 | United States | Multicenter | 3 arms | 26 | Hemoglobin A1c | Yes | GlaxoSmithKline |
113 | 8 mg/day | 58.8/58.3 | |||||||||||||
Genovese et al.42 | 213 | 110 | 103 | 2550 mg/day | Pioglitazone | 30 mg/day | 57.8/57 | 127/86 | Italy | Multicenter | 2 arms | 24 | serum HDL cholesterol | Not reported | Takeda |
Goke et al.43 | 590 | 194 | 200 | 2000 to 2500 mg/day | Tesaglitazar | 0.5 mg/day | 60.1/59.1 | 332/258 | Global | Multicenter | 3 arms | 24 | Hemoglobin A1c | Yes | AstraZeneca |
196 | 1 mg/day | 60.1/58.4 | |||||||||||||
Gomez-Perez et al.44 | 116 | 37 | 39 | 2500 mg/day | Rosiglitazone | 4 mg/day | 53.4/51.7 | 27/78 | Mexico | Multicenter | 3 arms | 26 | Hemoglobin A1c | Yes | Not reported |
40 | 8 mg/day | 53.4/54.2 | |||||||||||||
Hanefeld et al.24 | 81 | 39 | 42 | 1700 mg/day | Pioglitazone | 30 mg/day | 64.2/63.3 | 49/22 | Germany | Multicenter | 3 arms enrolled, 2 included in SR | 24 | Matrix Metallo Proteinase 9 | Yes | Takeda |
Kadoglou et al.22 | 100 | 50 | 50 | 850 to 2550 mg/day | Rosiglitazone | 8 mg/day | 62.7/62 | 29/68 | Greece | Single center | 2 arms | 14 | Emergence of novel cardiovascular risk factors | Not reported | European Social Fund and National Resources and Aristotle University Of Thessaloniki |
Kadoglou et al.45 | 140 | 70 | 70 | 1700 mg/day | Rosiglitazone | 4 mg/day | 62.7/62 | 37/99 | Greece | Not reported | 2 arms | 24 | Serum adipokine | Not reported | European Social Fund and National Resources and Aristotle University Of Thessaloniki |
Kaku et al.25 | 169 | 83 | 86 | 500 or 700 mg/day | Pioglitazone | 15 mg/day | 53/52 | 104/65 | Japan | Multicenter | 2 arms | 28 | Hemoglobin A1c | Yes | Takeda |
Negro et al.23 | 38 | 19 | 19 | up to 2550 mg/day | Rosiglitazone | 8 mg/day | 59/60.3 | 22/16 | Italy | Not reported | 2 arms | 52 | Not reported | Not reported | Not reported |
Perez et al.46 | 411 | 201 | 210 | 1700 mg/day | Pioglitazone | 30 mg/day | 53.7/54.7 | 188/223 | Multinational | Multicenter | 3 arms enrolled, 2 included in SR | 24 | Hemoglobin A1c | Yes | Takeda |
Rosenstock et al.47 | 309 | 155 | 154 | 2000 mg/day | Rosiglitazone | 8 mg/day | 51.5/50.1 | 176/133 | Global | Multicenter | 3 arms enrolled, 2 included in SR | 32 | Hemoglobin A1c | Yes | GlaxoSmithKline |
Scott et al.48 | 179 | 87 | 92 | ≥ 1500 mg/day | Rosiglitazone | 8 mg/day | 55.3/54.8 | 109/70 | Multinational | Multicenter | 3 arms enrolled, 2 included in SR | 18 | Hemoglobin A1c | Not reported | Merck |
Stewart et al.49 | 526 | 254 | 272 | 500 mg/day | Rosiglitazone | 8 mg/day | 59/58.9 | 290/236 | Europe | Multicenter | 2 arms | 32 | Hemoglobin A1c | Yes | GlaxoSmithKline |
Takeda36 | 315 | 157 | 158 | 1000 mg/day | Pioglitazone | 30 mg/day | 57.6/56.7 | 133/179 | Americas | Multicenter | 2 arms | 16 | Hemoglobin A1c | Not reported | Takeda |
Wang et al.50 | 36 | 24 | 12 | 1000 or 1500 mg/day | Pioglitazone | 30 mg/day | 58/60 | 17/19 | Not reported | Not reported | 2 arms | 8 | Not reported | Not reported | Not reported |
Weissman et al.51 | 766 | 382 | 384 | 2000 mg/day | Rosiglitazone | 8 mg/day | 55.7/55.5 | 362/347 | United States | Multicenter | 2 arms | 24 | Hemoglobin A1c | Yes | GlaxoSmithKline |
