Table 1.
Characteristics of studies.
| Study | Phase | Trial design | Key inclusion criteria | T2DM | Duration (weeks) | Sample size lira/placebo | Mean BMI (SD) lira/placebo at baseline | Diet/behavioural therapy | ||
|---|---|---|---|---|---|---|---|---|---|---|
| Astrup et al. [24] | 2 | Double-blind | 18–65 years, with BMI of 30–40 kg/m², and FPG of less than 7 mmol/L at the run-in period | No | 20 | 93 | 98 | 34·8 (2·8) | 34.9 (2.8) | Reduced-calorie diet and maintain or increase physical activity |
| Blackman et al. [25] | 3 | Double-blind | 18–64 years with BMI ≥30 kg m2 diagnosed with moderate/severe OSA | No | 32 | 180 | 179 | 38.9 (6.4) | 39.4 (7.4) | Reduced-calorie diet and increased physical activity |
| Davies et al. [26] | 3 | Double-blind | Age 18 years or older with BMI of ≥27.0 taking 0 to 3 oral hypoglycaemic agents and HbA1c level 7.0% to 10.0% | Yes | 56 | 423 | 212 | 37.1 (6.5) | 37.4 (7.1) | Reduced-calorie diet and increased physical activity |
| Garvey et al. [27] | 3 | Double-blind | Aged ≥18 years and BMI ≥27 kgm2 with an ≥HbA1c 6.0 to ≥10% and T2DM treated with basal insulin and less than or equal to two OADs | Yes | 56 | 198 | 198 | 35.9 (6.5) | 35.3 (5.8) | Intensive behaviour therapy |
| Gudbergsen et al. [28] | 4 | Double-blind | Aged 18 and 74 y with BMI ≥27 kg m2 with knee osteoarthritis | No | 52 | 80 | 76 | 32.8 (5.5) | 31.3 (4.0) | Nutritional counselling |
| Halawi et al. [29] | 2 | Double-blind | Aged 18 and 65 years with BMI ≥27.0 kg/m2, with an obesity-related comorbidity, and adults with obesity (BMI >30 kg/m²), | No | 26 | 19 | 21 | 37.2 (7.5) | 34.6 (2.6) | Dietary and exercise interventions |
| Lean et al. [30] | 2 | Double-blind | Aged 18–65 yrs with BMI ≥30 and ≤40 kgm and FPG <7.0 mmolL | No | 52 | 93 | 98 | 34.8 (2.8) | 34.9 (2.8) | Reduced-calorie diet and increased physical activity |
| Nexøe-Larsen et al. [31] | 1 | Double-blind | Aged 18 and 64 years with BMI ≥27.0 kg/m2, ultrasound assessment of gallbladder volume of acceptable quality at screening overweight and obese subjects | No | 12 | 26 | 26 | 32.5 (3.6) | 32.6 (3.3) | Nutritional and physical activity counselling |
| O'Neil et al. [32] | 2 | Double-blind | Aged ≥18 years and BMI ≥30 kgm−2 | No | 52 | 103 | 136 | 38·6 (6·6) | 40·1 (7·2) | Dietary and exercise interventions |
| Pi-Sunyer et al. [33] | 3 | Double-blind | Aged ≥18 years and BMI ≥30 kgm−2 or ≥27 kgm2 with comorbidities of treated or untreated dyslipidaemia and/or treated or untreated hypertension | No | 56 | 2487 | 1244 | 38.3 (6.4) | 38.3 (6.3) | Reduced-calorie diet and increased physical activity |
| Tronieri et al. [34] | 4 | Open label | Aged 21–70 years with BMI ≥30 and ≤55 kg/m² and had no serious medical or psychological conditions | No | 52 | 36 | 37 | 39.2 (5.0) | 37.6 (4.1) | Intensive behaviour therapy |
| Wadden et al. [35] | 3 | Double-blind | Aged ≥18 years with BMI ≥30 kgm2 or ≥27 kgm2 with comorbidities of treated or untreated dyslipidaemia and/or treated or untreated hypertension | No | 56 | 212 | 210 | 38.3 (6.4) | 38.3 (6.3) | Reduced-calorie diet and increased physical activity |
| Wadden et al. [36] | 4 | Open label | Aged 21–70 years with BMI of 30–55 kg/m2; prior lifetime weight-loss effort with diet and exercise | No | 52 | 50 | 50 | 38.5 (5.4) | 38.0 (4.3) | Intensive behaviour therapy |
| Wadden et al. [37] | 3 | Double-blind | Aged ≥18 years, with BMI ≥30 kg/m2 | No | 56 | 142 | 140 | 39.3 (6.8) | 38.7 (7.2) | Intensive behaviour therapy |