Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan

PHASE4CompletedINTERVENTIONAL
Enrollment

557

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

September 30, 2013

Study Completion Date

September 30, 2013

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Vildagliptin

Patients will be instructed to take Vildagliptin tablets at a fixed dose of 50 mg twice daily (double blind therapy)

DRUG

Gliclazide

Patients will be instructed to take Gliclazide capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy)

DRUG

Metformin

Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion

DRUG

Placebo to Gliclazide

Patients will be instructed to take the Gliclazide matching placebo capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy)

DRUG

Placebo to Vildagliptin

Patients will be instructed to take Vildagliptin matching placebo tablets at a fixed dose of 50 mg twice daily (double blind therapy).

Trial Locations (68)

470

Novartis Investigative Site, Hazmiyeh

1002

Novartis Investigative Site, Le Belvedere - Tunis

1007

Novartis Investigative Site, Tunis

Novartis Investigative Site, Tunis

1180

Novartis Investigative Site, Kuwait City

1819

Novartis Investigative Site, Frederiksberg

3029

Novartis Investigative Site, Sfax

4000

Novartis Investigative Site, Sousse

5000

Novartis Investigative Site, Monastir

10220

Novartis Investigative Site, Jakarta

10430

Novartis Investigative Site, Jakarta

10997

Novartis Investigative Site, Berlin

11196

Novartis Investigative Site, Amman

11426

Novartis Investigative Site, Riyadh

11566

Novartis Investigative Site, Cairo

16150

Novartis Investigative Site, Kota Bharu

17007

Novartis Investigative Site, Girona

17190

Novartis Investigative Site, Salt

21131

Novartis Investigative Site, Alexandria

25127

Novartis Investigative Site, Padang

29010

Novartis Investigative Site, Málaga

32549

Novartis Investigative Site, Bad Oeynhausen

32584

Novartis Investigative Site, Löhne

34093

Novartis Investigative Site, Istanbul

34304

Novartis Investigative Site, Istanbul

35380

Novartis Investigative Site, Izmir

37574

Novartis Investigative Site, Einbeck

38527

Novartis Investigative Site, Meine

40145

Novartis Investigative Site, Dammam

44137

Novartis Investigative Site, Dortmund

46050

Novartis Investigative Site, Kahramanmaraş

51002

Novartis Investigative Site, Ceuta

52005

Novartis Investigative Site, Melilla

59100

Novartis Investigative Site, Kuala Lumpur

60286

Novartis Investigative Site, Surabaya

65111

Novartis Investigative Site, Malang

66740

Novartis Investigative Site, Saarlouis

80339

Novartis Investigative Site, München

86150

Novartis Investigative Site, Augsburg

86159

Novartis Investigative Site, Augsburg

191015

Novartis Investigative Site, Saint Petersburg

199034

Novartis Investigative Site, Saint Petersburg

344000

Novartis Investigative Site, Rostov-on-Don

344718

Novartis Investigative Site, Rostov-on-Don

350063

Novartis Investigative Site, Krasnodar

410012

Novartis Investigative Site, Saratov

440026

Novartis Investigative Site, Penza

440080

Novartis Investigative Site, Singapore

450000

Novartis Investigative Site, Ufa

545025

Novartis Investigative Site, Singapore

659164

Novartis Investigative Site, Singapore

1107 2020

Novartis Investigative Site, Beirut

Unknown

Novartis Investigative Site, Beirut

Novartis Investigative Site, Saida

Novartis Investigative Site, Tunis

Novartis Investigative Site, Dubai

08001

Novartis Investigative Site, Barcelona

08923

Novartis Investigative Site, Santa Coloma de Gramanet

08500

Novartis Investigative Site, Vic

06770

Novartis Investigative Site, Diskapi / Ankara

LE5 4PW

Novartis Investigative Site, Leicester

W6 7HY

Novartis Investigative Site, London

B15 2TT

Novartis Investigative Site, Birmingham

B8 3Sw

Novartis Investigative Site, Birmingham

B9 5SS

Novartis Investigative Site, Birmingham

BL4 0JR

Novartis Investigative Site, Bolton

DE22 3NE

Novartis Investigative Site, Derby

M13 9WL

Novartis Investigative Site, Manchester

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY