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11111 Ingelheim

Informasi studi pendukung "Add on to insulin" kami lam irkan kembali dalam bentuk CD sesuai tabel berikut:
No Study No Title of Study
1 U10-2372-02 Tausend S, Jones R, Zander K, Friedrich C. A Phase III randomised, double-blind, placebo-
(1218.46) controlled parallel
group study to compare the efficacy and safety of twice dailyadministration of the free
combination of linagliptin 2.5 mg +metformin 500 mg or of linagliptin 2.5 mg + metformin
1000 mg, with the individual components of metformin (500 mg or 1000 mg, twice daily)
and linagliptin (5 mg, once daily) over 24 weeks in drug naive or previously treated (4 weeks
washout and 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic
control
2 U11-1781-02 Huisman, Holger, Glund S. A Phase III randomised, double-blind, placebo-controlled,
(1218.63) parallel group efficacy and safety study of Linagliptin (5 mg), administered orally once daily
over 24 weeks in type 2 diabetic patients (age > 70 years) with insufficient glycaemic
control
(HbAlc > 7.0%) despite metformin and/or sulphonylurea and/or insulin therapy.
3 U11-2286-01 Pinnetti, S, Brown C, Bhattacharya S. A Phase HI randomised, double-blind, placebo-
(1218.36 controlled, parallel group efficacy and safety study of Linagliptin (5 mg), administered orally
interim) once daily for at least 52 weeks in type 2 diabetic patients in combination with basal insulin
therapy.
4 U12-1511-01 Pinnetti, S, Brown C, Bhattacharya S. A Phase HI randomised, double-blind, placebo-
(1218.36 controlled, parallel group efficacy and safety study of Linagliptin (5 mg), administered orally
final) once daily for at least 52 weeks in type 2 diabetic patients in combination with basal insulin
therapy.
5 U11-3170- Newman J. A phase III, randomised, double-blind, placebo-controlled, parallel
01 group, safety and efficacy study of BI 1356 (5 mg), compared to placebo
(1218.43)
6 U13-3654-01 A 24-week, randomized, double-blind, active-controlled, parallel group trial to assess the
(1218.83) superiority of oral linagliptin and metformin compared to linagliptin monotherapy in newly
diagnosed, treatment-naïve, uncontrolled Type 2 Diabetes Mellitus patients (Phase IV)
7 U11-3093-01 Rafeiro E, Toorawa R, Whiting G, Friedrich C. A randomised, double-blind, placebo-
(1218.62) controlled, 3 parallel group efficacy and safety study of linagliptin 2.5 mg twice daily versus
5 mg once daily over 12 weeks as add-on therapy to a twice daily dosing regimen of
metformin in patients with type 2 diabetes mellitus and insufficient glycaemic
control.
(Phase 11b)

Untuk pembuktian fixed dose combination nya telah dilakukan Uji Bioekuivalensi pada saat evaluasi untuk
-

memperoleh persetujuan awal Trajenta Duo di tahun 2013. Terlampir disampaikan kembali studi pendukung
bioekuivalensi dalam bentuk CD sebagai berikut :

No Study No Title of Study

1 U10-2278-02 Bioequivalence of 2.5 mg Lina/1000 mg Met fixed dose combination tablet compared to
(1288.1) single tablets of Lina 2.5 mg and Met 1000 mg administered together in healthy male and
female
volunteers (an open label, randomize, single dose, two-way crossover Phase 1 trial)
2 U10-2276-01 Bioequivalence of a 2.5 mg linagliptin / 500 mg metformin fixed dose combination tablet
(1288.2) compared with single linagliptin 2.5 mg and metformin 500 mg tablets administered
together in healthy male and female volunteers (an open-label, radomized, single dose,
two-way crossover, Phase I trial)
3 U10-2303-01 Bioequivalence of 2.5 mg Lina/850 mg Met fixed dose combination tablet compared to
(1288.3) single tablets of Lina 2.5 mg and Met 850 mg administered together