Table 2.
Main clinical studies of dipeptidyl peptidase-4 inhibitors (DPP-4 i) in PCOS.
| References | Study population | Study arms | Duration | Primary outcome | Weight loss (kg) | Metabolic changes |
|---|---|---|---|---|---|---|
| Devin et al.73 | Women with PCOS | (1) Sitagliptin 100 mg QD (n = 18). (2) Placebo QD (n = 18). |
1 month | Increases GH levels Improves glucose levels and vascular function |
– | Decreased peak glucose [−17.2 mg/dL (95% CI −27.7 to −6.6); p < 0.01]. Decreased VAT (1141.9 ± 700.7–1055.1 ± 710.1 g; p = 0.02). Increase GH-half-life (13.9 ± 3.6–17.0 ± 6.8 min, n = 16; p = 0.04). |
| Ferjan et al.75 | Obese women with PCOS and metformin intolerant BMI (36.9 ± 5.5 kg/m2). |
(1) Sitagliptin 100 mg QD (n = 30). (2) Lifestyle intervention (placebo, n = 30). |
12 weeks | Glycaemic control (OGTT, HOMA-B) | – | (1) Sitagliptin BMI (+37 ± 6.2–37.8 ± 5.9kg/m²). (2) Placebo BMI (+36.8 ± 4.9–38 ± 5kg/m²) |
| Ferjan et al.76 | Obese women with PCOS pre-treated with LIRA 3 mg BMI (36.3 ± 5.2 kg/m2). |
(1) COMBO (sitagliptin 100 mg QD and MET 1000 mg BID, n = 15) (2) MET 1000 mg BID (n = 12) |
12 weeks | Anthropometric measures | (1) +0.9 ± 2.5 (2) +4.7 ± 2.7 |
(1) BMI (+0.3 ± 0.8 kg/m²), regain body weight (0.8% ± 2.6%). (2) BMI (+1.7 ± 0.9 kg/m²), regain body weight (4.5% ± 2.5%). |
| Jensterle et al.77 | Obese women with PCOS and persistent IR pre-treated with MET 1000 mg BID | (1) ALO 25 mg QD (n = 15) (2) ALO 25 mg QD and PIO 30 mg QD (n = 15) |
12 weeks | β-cell function and IR | – | (1) MET + ALO reduced HOMA-IR (1.6 ± 2.3, p = 0.039) increased IS (31.4 ± 97.5 ml·min–1·m–2, p = 0.007). (2) MET + ALO + PIO reduced HOMA-IR (2.9 ± 3.3, p = 0.001), IS (39.0 ± 58.1 ml·min–1·m–2 (p = 0.039) |
| El-Halwagy et al.78 | Women with PCOS diagnose by the Rotterdam criteria | (1) PIO 30 mg QD (n = 35) (2) Vildagliptin 50 mg QD (n = 35) (3) MET 500 mg TDS (n = 35) |
6 months | Menstrual regularity, changes in BMI, F–G hirsutism score | – | (1) BMI (27.5 ± 5.2–27.0 ± 4.5, p < 0.016), FG scores (12.0 ± 7.4–10.74 ± 6.12), DHEA (263.7 ± 117–221.0 ± 82.2). (2) BMI (28.0 ± 5.1–27.3 ± 4.5, p < 0.001), F–G scores (11.8 ± 7.9–12.4 ± 7.1), DHEA (271.9 ± 126.5–353.1 ± 362.5). (3) BMI (25.8 ± 5.7–25.3 ± 5.0, p < 0.010), F–G scores (12.3 ± 7.4–10.8 ± 5.5), DHEA (280.7 ± 132.2–243.3 ± 103.5). |
ALO, alogliptin; BMI, body mass index; GH, growth hormone; HOMA-B, homeostatic model analysis for β-cell; HOMA-IR, homeostatic model analysis of insulin resistance; IR, insulin resistance; IS, insulin sensitivity; LIRA, liraglutide; MET, metformin; OGTT, oral glucose tolerance test; PCOS, polycystic ovary syndrome; PIO, pioglitazone; VAT, visceral adiposity.