Study Design | Regimen (mg) | Study duration (weeks) | No. of patients | Placebo-subtracted LSM change from BL to study end (mean BL value) | HOMA-β | HOMA-R | % Patients with HbA1c < 7.3% | % Patients with HbA1c < 6.8% | ||
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| HbA1c (%) | FPG (mg/dL) | 2h-PPG (mg/dL) |
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Monotherapy [12] | Tene 10 mg | 4 | 33 | - | −13.8*a (169.2) | Breakfast-50.7*a (272.6) Lunch-34.8*a (248.9) Dinner-37.5*a (255.1) | - | - | - | - |
Tene 20 mg | 34 |
| −13.6*a (163.1) | Breakfast-38.1*a (261.5) Lunch-28.6***a (244.5) Dinner-36.1*a (245.9) |
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PL | 32 |
| (153.6) |
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Monotherapy [11] | Tene 10 mg | 12 | 84 | −0.9* (7.9) | −17.8* (148.0) | −50.6* (240.0) | 4.4** (26.0) | 0.0 (2.2) | 43.8*b | 30.0*b |
Tene 20 mg | 79 | −0.9* (7.8) | −16.9* (143.0) | −56.8* (231.9) | 8.3* (23.3) | 0.1 (1.8) | 53.5*b | 37.9*b | ||
Tene 40 mg | 81 | −1.0* (7.7) | −20.0* (141.9) | −58.6* (224.2) | 3.6 (26.6) | −0.3 (2.0) | 67.0b | 48.7*b | ||
PL | 80 | (8.0) | (150.0) | (242.0) | (24.4) | (2.1) |
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Monotherapy [46] | Tene 20 mg | 24 | 99 | −0.94$ (7.63) | −21.78$f (155.16) | - | 12.23+ (36.24) | −0.24++ (3.58) | 69.39*g | 34.69h |
PL | 43 | (7.77) | (161.28) | - | (30.91) | (3.25) | 20.93g | 4.65 | ||
Add-on Therapy (Tene + Glim) Double-blind [47] | Tene 20 mg + Glim 1 - 4 mg/day | 12 | 96 | −1.0* (8.4) | −27.1* (165.1) | −49.1* (258.6) | 9.1* (25.3) | −0.2 (2.8) | 31.6 | 8.3 |
PL+ Glim 1 - 4 mg/day | 98 | (8.4) | (163.4) | (256.1) | (24.9) | (2.9) | 2.1 | 0.0 | ||
Add-on Therapy (Tene + Glim) open label extension studyd [47] | T/T | 40 | 95 | −0.6*ce | −7.7**ce | −32.8*ce (258.6) | 9.3*ce (25.3) | 0.2c (2.8) |
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P/T | 95 | −0.9*ce | −14.4*ce | −35.6*ce (262.8) | 8.8*ce (24.8) | 0.1c (3.2) | - | - | ||
Add-on Therapy (Tene + Pio) Double-blind [48] | Tene 20 mg + Pio 15 - 30 mg/day | 12 | 103 | −0.7* (8.1) | −16.4* (150.7) | −51.3* (230.9) | 6.9* (29.8) | −0.6 (2.5) | - | - |
PL+ Pio 15 - 30 mg/day | 101 | 7.9 | (145.7) | (221.5) | (25.9) | (2.0) |
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Add-on Therapy (Tene + Pio) open label extension studyd [48] | T/T | 40 | 98 | −0.9*c | −12.1*c | −37.4*c | 8.1*c | 0.1c | - | - |
P/T | 98 | −0.7*c | −9.1*c | −41*c | 6.4*c | 0.0c |
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