Table 3.
Proportion of patients with hypoglycemic events
| Patients n/N (%) | Overall RI | Moderate RI | Severe RI | ESRD | ||||
|---|---|---|---|---|---|---|---|---|
| Active | PBO | Active | PBO | Active | PBO | Active | PBO | |
| Linagliptin [19, 20] | ||||||||
| 12 weeks | 43/118 (36.4) | 48/123 (39.0) | – | – | 33/68 (48.5) | 17/65 (26.2) | – | – |
| 52 weeks | a | a | – | – | 43/68 (63.2) | 32/65 (49.2) | – | – |
| Saxagliptin [17, 18] | ||||||||
| 12 weeks | 17/85 (20.0) | 19/85 (22.4) | 10/48 (20.8) | 12/42 (28.6) | 5/18 (27.8) | 3/23 (13.0) | 2/19 (10.5) | 4/20 (20.0) |
| 52 weeks | 24/85 (28.2) | 25/85 (29.4) | 14/48 (29.2) | 16/42 (38.1) | 6/18 (33.3) | 4/23 (17.4) | 4/19 (21.1) | 5/20 (25.0) |
| Sitagliptina [16] | ||||||||
| 12 weeks | 3/65 (4.6) | 1/26 (3.8) | – | – | – | – | – | – |
| Vildagliptin [14, 15] | ||||||||
| 24 weeksb | 47/287 (16.4) | 27/226 (11.9) | 28/163 (17.2) | 15/129 (11.6) | 19/124 (15.3) | 12/97 (12.4) | – | – |
| 52 weeks | 49/216 (22.7) | 26/153 (17.0) | 32/122 (26.2) | 15/89 (16.9) | 17/94 (18.1) | 11/64 (17.2) | – | – |
ESRD end-stage renal disease, PBO placebo, RI renal impairment, SMBG self-monitored blood glucose
aNot included long-term data for sitagliptin [16] and linagliptin [20] studies because of its combined placebo and active-controlled phase. All hypoglycemic events observed in the study were mild or non-severe in nature. In the vildagliptin study, hypoglycemia was defined as symptom suggestive of low blood glucose confirmed by SMBG measurement <3.1 mmol/L plasma glucose equivalent. Severe hypoglycemia was defined as any episode requiring assistance from another person whether or not a confirmatory SMBG measure was available [14, 15]. In the saxagliptin study, hypoglycemia was defined as any event consistent with signs or symptoms of hypoglycemia with or without documented glucose levels. Confirmed hypoglycemia was defined by a finger-stick glucose value ≤2.8 mmol/L with associated symptoms [17, 18]. In the linagliptin study, hypoglycemia was defined as symptoms suggestive of low blood glucose confirmed by SMBG measurement <3.9 mmol/L plasma glucose equivalent. Severe hypoglycemia was defined as any event requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions [19, 20]
b12-week data unavailable for vildagliptin