Table 1.
Characteristics of included studies
| References | Study duration (weeks) | Intervention, daily dose (No of patients) | Associated sulphonylureas | Mean haemoglobin A1c at baseline (%) | Mean age of participants (years) | Male (%) | Definition of hypoglycaemia |
|---|---|---|---|---|---|---|---|
| Barnett et al27 | 24 | Linagliptin 5 mg (n=95) or placebo (n=43) | Sulphonylureas, not specified | DPP-4 inhibitors: 7.8, placebo: 7.7* | DDP-4 inhibitors: 75, placebo: 75* | DDP-4 inhibitors: 72, placebo: 62* | Plasma glucose ≤3.9 mmol/L, with or without symptoms |
| Chacra et al45 | 24 | Saxagliptin 2.5 mg (n=248), saxagliptin 5 mg (n=253), or placebo (n=267) | Glyburide | DDP-4 inhibitors: 8.4-8.5, placebo: 8.4 | DDP-4 inhibitors: 55, placebo: 55 | DDP-4 inhibitors: 45, placebo: 46 | NR |
| Garber et al46 | 24 | Vildagliptin 50 mg (n=170) or 100 mg (n=169), or placbeo (n=176) | Glimepiride | DDP-4 inhibitors: 8.5-8.6, placebo: 8.5 | DDP-4 inhibitors: 58-59, placebo: 58 | DDP-4 inhibitors: 59, placebo: 58 | Symptomatic hypoglycaemia confirmed by self monitored blood glucose <3.1 mmol/L |
| Hermansen et al47 | 24 | Sitagliptin 100 mg (n=222) or placebo (n=219) | Glimepiride | DDP-4 inhibitors: 8.3, placebo: 8.3 | DDP-4 inhibitors: 56, placebo: 56.5 | DDP-4 inhibitors: 53, placebo: 53 | NR, but hypoglycaemia is included in adverse events of special interest |
| Kikuchi et al48 | 12 | Vildagliptin 100 mg (n=102) or placebo (n=100) | Glimepiride | DDP-4 inhibitors: 7.8, placebo: 8.0 | DDP-4 inhibitors: 59, placebo: 60 | DDP-4 inhibitors: 73.5, placebo: 69 | Symptomatic hypoglycaemia, confirmed by self monitored blood glucose <3.1 mmol/L |
| Lewin et al49 | 18 | Linagliptin 5 mg (n=161) or placebo (n=84) | Sulphonylureas, not specified | DDP-4 inhibitors: 8.6, placebo: 8.6 | DDP-4 inhibitors: 57, placebo: 56 | DDP-4 inhibitors: 48, placebo: 62 | NR, but hypoglycaemia was recorded and analysed separately from other adverse events |
| Owens et al50 | 24 | Linagliptin 5 mg (m=792) or placebo (m=263) | Sulphonylureas, not specified | DDP-4 inhibitors: 8.1, placebo: 8.1 | DDP-4 inhibitors: 58, placebo: 58 | DDP-4 inhibitors: 48, placebo: 47 | NR |
| Pratley et al 51 | 26 | Alogliptin 12.5 mg (n=203), alogliptin 25 mg (n=198), or placebo (m=99) | Glyburide | NR | DDP-4 inhibitors: 56.5, placebo: 57 | DDP-4 inhibitors: 52, placebo: 51.5 | Symptomatic hypoglycaemia with blood glucose <3.3 mmol/L or <2.8 mmol/L without symptoms |
| Seino et al52 | 12 | Alogliptin 12.5 mg (n=105), alogliptin 25 mg (n=104), or placebo (n=103) | Glimepiride | DDP-4 inhibitors: 8.5%, placebo: 8.6% | DDP-4 inhibitors: 60, placebo: 60 | DDP-4 inhibitors: 66, placebo: 69 | NR |
| White et al53 | 76† | Alogliptin any doses (n=1198), or placebo (n=1172) | Sulphonylureas, not specified | DDP-4 inhibitors: 8.0, placebo: 8.0* | DDP-4 inhibitors: 61, placebo: 61‡ | DDP-4 inhibitors: 68, placebo: 69* | NR |
DDP-4=dipeptidyl peptidase-4; haemoblobin A1c =glycated haemoglobin; NR=not reported.
*Data refer to overall study population, not only to patients treated with sulphonylureas.
†Median use (weeks) for patients treated with alogliptin.
‡Median age (years).