Table 3.
Representative renal outcomes studies of incretin-based therapies and SGLT2 inhibitors.
| Intervention | Study Design (N) | Background Therapy | Baseline Renal Parameters | Key Renal Outcomes | ||
|---|---|---|---|---|---|---|
| Mean UACR (mg/g) | Mean eGFR (mL/min/1.73m2) |
Mean Change in UACR (95% CI)
(% Change or mg/g) |
Other | |||
| Linagliptin 5 mg Placebo [25] |
Pooled analysis of 4, 24-week, phase 3 RCTs (217) |
Stable ACEI/ARB therapy*± OADs | 73.8 (30.1–2534.4)† 80.5 (30.9–1538.2)† |
83.6 (35.8–189.7)† 87.9 (39.6–138.4)† |
−32 (−42, −21)‡ (linagliptin) −6 (−27, +23)‡ (placebo) |
eGFR§: −1.3 (linagliptin) −0.2 (placebo) |
| Alogliptin 25 mg Sitagliptin 50 mg [26] |
12-week, open-label, crossover study (8) | ARBs + other OADs | NR | 66.2 ± 9.3 | 33.9 ± 23.9ǁ (alogliptin) 81.0 ± 52.4ǁ (sitagliptin) |
eGFR: 64.7 ± 8.4 (alogliptin) 65.8 ± 8.0 (sitagliptin) sCr¶: 0.87 ± 0.21 (alogliptin) 0.84 ± 0.19 (sitagliptin) |
| Sitagliptin 50 mg [29] | 6-month observational cohort study (36) | Other OADs, ARBs, or statins | 11.6 ± 8.4 (normoalbuminuric) 98.4 ± 79 (microalbuminuric) 1263 ± 492 (macroalbuminuric) |
73.3 ± 16.3 | −4.5 ± 5.0 (normoalbuminuric) −24.9 ± 20 (microalbuminuric) −561 ± 89 (macroalbuminuric) |
eGFR: 77.0 ± 19.4 |
| Empagliflozin 25 mg** Placebo [46] |
52-week phase 3 RCT (741) | Antihypertensive + other anti-diabetes drugs | NR†† | Stage 2 CKD: 71.6 (10.6) stage 3 CKD: 44.9 (10.2) stage 4 CKD: 23.2 (4.9) |
Stage 2 CKD: −235.86 (−442.85, −28.86) stage 3 CKD: −183.78 (−305.18, −62.38) |
Slight decrease in eGFR for all stages of CKD that returned to baseline |
| Canagliflozin 100 mg Canagliflozin 300 mg Placebo [51] |
52-week, phase 3 RCT (269) | Antihypertensive + other anti-diabetes drugs | 255.8 221.6 257.7 |
39.8 38.8 40.0 |
−117.5 (canagliflozin 100 mg) −96.2 (canagliflozin 300 mg) 15.4 (placebo) |
eGFR‡‡: −3.6 (canagliflozin 100 mg) −3.9 (canagliflozin 300 mg) − 1.4 (placebo) |
*For ≥4 weeks before randomization.
†Median, range.
‡Percent change from baseline.
§Median change from baseline.
ǁMean values, mg/g.
¶sCr, baseline, 0.87 ± 0.20 mg/dL
**Patients with stage 2 CKD were randomized 1:1:1 to empagliflozin 10 mg, 25 mg, or placebo; data for 10 mg arm not shown.
††Numerical data not reported.
‡‡Mean change from baseline.
ACEI, angiotensin-converting enzyme inhibitor; ARB, angiotensin II receptor blocker; CI, confidence interval; CKD, chronic kidney disease; eGFR, estimated glomerular filtration; NR, not reported; OAD, oral antidiabetes drug; RCT, randomized controlled trial; sCr, serum creatinine; SGLT2, sodium glucose co-transporter 2; UACR, urine albumin to creatinine ratio.