Table 2. Studies included in the present review.
Studies | Patients | Intervention | Control | Major Outcomes | Ethnicity | Findings |
1). Kaku et al, 2010 | 264 patients on a SUa (glibenclamide, glicazide or glimeprimide) | Liraglutide 0.6 mg daily or 0.9 mg daily | Placebo with no active ingredients | 1). Change of HbA1c at 24 wks | Japanese | −1.46% to −1.56% (liraglutide)vs. −0.40% (placebo) |
2). Proportion reaching HbA1c<7.0% | 46.5% to 71.3% (liraglutide) vs. 14.8% (placebo) | |||||
2). Seino et al, 2012b | 267 patients aged ≥20 years with suboptimal glycaemic control (HbA1c 7.4% to <10.4%) | Liraglutide 0.6 mg or 0.9 mg daily | Placebo with no active ingredients | Change of HbA1c at 24 wks | Japanese | Mean HbA1c was reduced by 1.00% to 1.27% points than placebo. |
3). Kadowaki et al, 2011 | 179 patients who had suboptimal glycaemic control despite use of SUa alone or in combination with a biguanide or thiazolidinedione | Exenatide 5 µg BID or 10 µg BID offered subcutaneously | Placebo with no active ingredients | Change of HbA1c at 24 wks | Japanese | −1.34% to −1.62% (exenatide) vs. −0.28% (p<0.001) |
4). Inagaki et al, 2012 | 427 patients aged ≥20 years with insufficient glucose control | Exenatide QW 2 mg daily | Once daily insulin glarigine (starting dose 4U) | Change of HbA1c at 26 wks | Japanese | −1.11% (exenatide QW) vs. −0.68% (insulin Glargine), p<0.001 with the 95% C.I. upper limit <predefined non-inferiority margin (0.4%) |
5). Seino et al, 2012a | 311 patients aged 25–81 years with Hba1c between 7–10% and on basal insulin +/− SUa | Lixisenatide starting from 10 µg to 15 µg and 20 µg | Placebo with no active ingredients | Change of HbA1c at 24 wks | Japan, Republic of Korea, Taiwan, the Phillipines | −0.77% (lixisenatide) vs. 0.11% (placebo) (p<0.0001) |
6). Inagaki et al, 2013 | 618 patients aged ≥20 years on SUa or A-GIb | Linagliptin 5 mg daily | Metformin BD or TDS, up to 2,250 mg/day | 1). Change of HbA1c at 52 wks | Japanese | 1). −0.7% to −0.9% (linagliptin) vs. −0.8% to −1.0% (metformin), p = NSc |
2).Hypoglycaemic attack rates | 2). 1.6% to 13.7% (linagliptin) vs. 3.2% to 15.9% (metformin); p = NSc | |||||
7). Zeng et al, 2013 | 192 patients on metformin and a SUa | Linagliptin 5 mg daily | Placebo with no active ingredients | 1). Change of HbA1c at 24 wks | Chinese | 1). −0.59% (linagliptin) vs. 0.08% (placebo), p<0.0001 |
2). Change in FPG | 2). −3.9 mg/dL (linagliptin) vs. 15.0% (placebo), p<0.001 | |||||
3). Adverse event rates | 3). 38.9% (linagliptin) vs. 43.8% (placebo), p = NSc | |||||
8). Takihata et al, 2013 | 115 patients inadequately controlled with metformin and/or sulphonylurea | Sitagliptin 50 mg daily | Pioglitazone 15 mg daily | Change of HbA1c at 24 wks | Japanese | −0.86 (SD 0.63%) (sitagliptin) vs. −0.58 (SD 0.68%) (pioglitazone), p = 0.024 |
9). Seino et al, 2012 | 312 Patients on glimepiride (1–4 mg/day) with poor glycaemic control | Alogliptin 12.5 mg or 25 mg | Placebo with no active ingredients | 1). Change of HbA1c at 12 wks | Japanese | 1). −0.59% to −0.65% (alogliptin) vs. 0.35% (placebo) |
2). Adverse events | 2). Comparable event rates with the majority being mild |
SU = sulphonylurea.
A-GI = α-glucosidase inhibitors.
NS = Non-significant.