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%

HbA1c (%)

FPG (mg/dL)

2h-PPG (mg/dL)

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)

PL

32

(153.6)

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)

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)

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)

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