| Intervention(s) and comparator(s) | Participants included in analysis (N) | Participants with hypoglycaemic episodes (N) | Participants with hypoglycaemic episodes (%) | Participants with nocturnal hypoglycaemic episodes (N/%) | Participants with severe/serious hypoglycaemic episodes (N/%) | Definition of severe/serious hypoglycaemia | Participants with specific adverse events (N) | Participants with specific adverse events (%) | |
| Avilés 1999 | I: metformin | 21 | 3 | 13.6 | ‐ | 0 | ‐ | ‐ | ‐ |
| C: placebo | 22 | 0 | 10 | ‐ | 0 | ‐ | ‐ | ||
| Barnett 2013 | I: saxagliptin | 95 | Reported: 22 Confirmed: 8 |
23.2 8.4 |
‐ | ‐ | ‐ | Urine tract infection: 7 Nasopharyngitis: 6 Upper resp. tract infection: 6 Headache: 5 Bronchitis: 4 Pharyngitis: 3 Influenza: 3 Hypertension: 4 Pain in extremity: 3 | Urine tract infection: 7.4 Nasopharyngitis: 6.3 Upper resp. tract infection: 6.3 Headache: 5.3 Bronchitis: 4.2 Pharyngitis: 3.2 Influenza: 3.2 Hypertension: 4.2 Pain in extremity: 3.2 |
| C: placebo | 46 | Reported: 15 Confirmed: 5 |
32.6 10.9 |
‐ | ‐ | Urine tract infection: 1 Nasopharyngitis: 1 Upper resp. tract infection: 5 Headache: 1 Bronchitis: 0 Pharyngitis: 3 Influenza: 2 Hypertension: 4 Pain in extremity: 2 | Urine tract infection: 2.2 Nasopharyngitis: 2.2 Upper resp. tract infection: 10.9 Headache: 2.2 Bronchitis: 0 Pharyngitis: 6.5 Influenza: 4.3 Hypertension: 8.7 Pain in extremity: 4.3 |
||
| Casner 1988 | I: glibenclamide | 31 | "complains compatible with mild hypoglycaemia were not different between the two groups." | ‐ | ‐ | 0 | ‐ | ‐ | ‐ |
| C: placebo | 33 | ‐ | ‐ | ‐ | 0 | ‐ | ‐ | ||
| Chiasson 1994 | I: acarbose | 35 | ‐ | 2.4 | ‐ | /2.4 | Required correction of hypoglycaemia | ‐ | Flatulence: 73.2 Diarrhoea: 43.6 Abdominal discomfort: 25.0 |
| C: placebo | 44 | ‐ | 6.0 | ‐ | /6.0 | ‐ | Flatulence: 39.0 Diarrhoea: 20.3 Abdominal discomfort: 8.8 | ||
| Coniff 1995 | I: acarbose | 103 | 0 | 0 | ‐ | ‐ | ‐ | Digestive system: 78 Flatulence: 34 | Digestive system: 76 Flatulence: 33 |
| C: placebo | 104 | 0 | 0 | ‐ | ‐ | Digestive system: 36 Flatulence: 14 | Digestive system: 35 Flatulence: 13 | ||
| Feinglos 1998 | I: glipizide | ‐ | ‐ | ‐ | ‐ | ‐ | Requiring assistance from another person | ‐ | |
| C: placebo | ‐ | ‐ | ‐ | ‐ | |||||
| all: | 29 | 69 total episodes, number of participants not mentioned | ‐ | ‐ | 1/ | ‐ | ‐ | ||
| Fonseca 2007 | I: vildagliptin | 114 | ‐ | 22.9 | ‐ | 0 | Requiring assistance of another party | ‐ | ‐ |
| C: placebo | 124 | ‐ | 29.6 | ‐ | ‐ | ‐ | ‐ | ||
| Fritsche 2000 | I: metformin | ‐ | 0 | 0 | 0 | 0 | ‐ | ‐ | ‐ |
| C: placebo | ‐ | 0 | 0 | 0 | 0 | ‐ | ‐ | ||
| all: | 13 | 0 | 0 | 0 | 0 | ‐ | ‐ | ||
| Giugliano 1993 | I: metformin | 27 | 0 | 0 | ‐ | ‐ | ‐ | Diarrhoea: 2 | Diarrhoea: 7.4 |
| C: placebo | 23 | 0 | 0 | ‐ | ‐ | Diarrhoea: ‐ | Diarrhoea: ‐ | ||
| Groop 1985 | I: glibenclamide | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: placebo | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ||
| all: | 13 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ||
| Hermann 2001 | I: metformin | 16 | 2 | ‐ | ‐ | 0 | ‐ | Diarrhoea: 6 Flatulence: 1 Epigastic pain: 0 Anorexia: 2 Constipation: 1 Sweating: 0 GI‐event: 8 | ‐ |
| C: placebo | 19 | 0 | ‐ | ‐ | 0 | Diarrhoea: 1 Flatulence: 3 Epigastric pain: 1 Anorexia: 1 Constipation: 1 Sweating: 1 GI‐event: 5 | ‐ | ||
| Hirsch 1999 | I: metformin | 25 | ‐ | ‐ | ‐ | 0 | ‐ | Gastro‐intestinal side effects: 3 | Gastro‐intestinal side effects: 12.0 |
| C: placebo | 25 | ‐ | ‐ | ‐ | 0 | Gastro‐intestinal side effects: 0 | Gastro‐intestinal side effects: 0 | ||
| Hong 2012 | I: sitagliptin | 61 | ‐ | 8.2 | ‐ | 1.6 | Any episode requiring assistance from another party with plasma glucose value < 3.0 mmol/L (54 mg/dL) | ‐ | ‐ |
| C: insulin increase | 63 | ‐ | 17.5 | ‐ | 4.8 | ‐ | ‐ | ||
| Kitabchi 1987 | I: tolazamide | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: NPH alone | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ||
| Krawczyk 2005 | I: metformin | 20 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: insulin alone | 20 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ||
| Kyllastinen 1985 | I: glibenclamide | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: placebo | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ||
| Lewitt 1989 | I: glibenclamide | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: placebo | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ||
| Lindström 1999 | I: glibenclamide | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: placebo | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ||
| all: | 15 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ||
| Longnecker 1986 | I: tolazamide | ‐ | 0 | 0 | 0 | ‐ | ‐ | ‐ | |
| C: placebo | ‐ | 0 | 0 | 0 | ‐ | ‐ | |||
| all: | 11 | 0 | 0 | 0 | ‐ | ‐ | |||
| Mattoo 2005 | I: pioglitazone | 128 | 109 | 63.4 | ‐ | ‐ | Requiring assistance | Oedema: 20 | Oedema: 14.1 |
| C: placebo | 135 | 98 | 51.0 | ‐ | ‐ | Oedema: 5 | Oedema: 3.4 | ||
| Mauerhoff 1986 | I: glibenclamide | 11 | 107 episodes | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: placebo | 11 | 25 episodes | ‐ | ‐ | ‐ | ‐ | ‐ | ||
| Mezitis 1992 | I: glibenclamide | 10 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: placebo | 10 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ||
| Mudaliar 2010 | I: pioglitazone | 12 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: placebo | 13 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ||
| Nemoto 2011 | I: miglitol | 107 | 122 episodes | 39.3 | 13 episodes | ‐ | ‐ | ‐ | Flatulence: 20.6 Diarrhoea: 14.0 Abdominal distension: 15.0 |
| C: placebo | 100 | 91 episodes | 35.0 | 29 episodes | ‐ | ‐ | Flatulence: 12.0 Diarrhoea: 4.0 Abdominal distension: 4.0 | ||
| Osei 1984 | I: glibenclamide | 6 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: placebo | 11 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ||
| Quartraro 1986 | I: gliclazide | 15 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: insulin alone | 15 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ||
| Reich 1987 | I: glibenclamide | 10 | 3 (5 episodes) | 30.0 | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: placebo | 10 | 10 episodes | ‐ | ‐ | ‐ | ‐ | ‐ | ||
| Relimpio 1998 | I: metformin | 24 | ‐ | ‐ | ‐ | 0 | ‐ | ‐ | ‐ |
| C: insulin dose increase | 23 | ‐ | ‐ | ‐ | 0 | ‐ | ‐ | ||
| Robinson 1998 | I: metformin | ‐ | ‐ | ‐ | ‐ | 0 | ‐ | ‐ | Diarrhoea: 5.0 Mild abdominal bloating: 5.0 |
| C: placebo | ‐ | ‐ | ‐ | ‐ | 0 | ‐ | Diarrhoea: 0 Mild abdominal bloating: 0 | ||
| all: | 19 | ‐ | ‐ | ‐ | 0 | ‐ | ‐ | ||
| Rosenstock 2002 | I1: pioglitazone 15 mg | 191 | ‐ | 7.9 | ‐ | 0 | ‐ | ‐ | Oedema: 12.6 |
| I2: pioglitazone 30 mg | 188 | ‐ | 15.4 | ‐ | 0 | ‐ | Oedema: 17.6 | ||
| C: placebo | 187 | ‐ | 4.8 | ‐ | 0 | ‐ | Oedema: 7.0 | ||
| Schade 1987 | I: glibenclamide | 16 | 6 | 37.5 | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: placebo | 16 | 1 | 6.3 | ‐ | ‐ | ‐ | ‐ | ||
| Schiel 2007 | I1: glimepiride | 17 | ‐ | 59 | ‐ | 0 | Need for intravenous glucose or glucagon | 0 | 0 |
| I2: glimepiride + metformin | 18 | ‐ | 72 | ‐ | 0 | Gastrointestinal discomfort: 2 | Gastrointestinal discomfort: 11.1 | ||
| C: insulin | 17 | ‐ | 77 | ‐ | 0 | 0 | 0 | ||
| Simpson 1990 | I: glipizide | 9 | 4 | 44.4 | ‐ | ‐ | ‐ | ‐ | ‐ |
| C: placebo | 10 | 0 | 0 | ‐ | ‐ | ‐ | ‐ | ||
| Stenman 1988 | I: glibenclamide | 15 | 13 | 86.7 | ‐ | 0 | ‐ | ‐ | ‐ |
| C: placebo | 15 | 8 | 53.3 | ‐ | 0 | ‐ | ‐ | ||
| Strowig 2002 | I1: metformin | 27 | 0.6 episodes per participant per month | ‐ | ‐ | 0 | Third party assistance | ‐ | Gastrointestinal side effects: 67 |
| I2: troglitazone | 30 | 1.7 episodes per participant per month | ‐ | ‐ | 0 | ‐ | Gastrointestinal side effects:36.7 | ||
| C: insulin | 31 | 2 episodes per participant per month | ‐ | ‐ | 1/3.2 | ‐ | Gastrointestinal side effects: 13 | ||
| Wulffelé 2002 | I: metformin | 171 | ‐ | 36.8 | ‐ | ‐ | Third party assistance | Diarrhoea: 9 Flatulence: 4 Pruritus: 1 Headaches: 1 Pyrosis: 0 Nausea: 1 | ‐ |
| C: placebo | 182 | ‐ | 32.4 | ‐ | ‐ | Diarrhoea: 2 Flatulence: 1 Pruritus: 0 Headaches: 0 Pyrosis: 1 Nausea: 0 | ‐ | ||
| Yilmaz 2007 | I1: acarbose | 15 | 1 | 6.7 | ‐ | 0 | Unable to treat themselves | Flatulence and bloating: 2 | Flatulence and bloating: 13.3 |
| I2: metformin | 17 | 2 | 11.8 | ‐ | 0 | Gastrointestinal side effects: 3 | Gastrointestinal side effects: 17.7 | ||
| I3: rosiglitazone | 15 | 2 | 13.3 | ‐ | 0 | Pretibial oedema: 1 | Pretibial oedema: 6.7 | ||
| C: insulin alone | 19 | 2 | 10.5 | ‐ | 0 | Pretibial oedema: 1 | Pretibial oedema: 5.3 | ||
| ‐ denotes not reported C: comparator; I: intervention; NPH: Neutral Protamine Hagedorn | |||||||||