Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Years Old

PHASE3CompletedINTERVENTIONAL
Enrollment

256

Participants

Timeline

Start Date

October 11, 2017

Primary Completion Date

February 1, 2023

Study Completion Date

January 3, 2024

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Dapagliflozin

Tablets, Oral, 5mg , Once daily Tablets, Oral, 10mg, Once daily

DRUG

Saxagliptin

Tablets, Oral, 2.5mg Once daily Tablets, Oral, 5mg, Once daily

DRUG

Placebo

Matching placebo to dapagliflozin 5mg and 10 mg/saxagliptin 2.5 mg and 5 mg, Tablets, oral, Once daily

Trial Locations (122)

112

Research Site, Taipei

704

Research Site, Tainan City

1023

Research Site, Grafton

1100

Research Site, Quezon City

1112

Research Site, Quezon City

2000

Research Site, San Fernando City

2148

Research Site, Blacktown

3110

Research Site, Tauranga

4000

Research Site, San Miguel de Tucumán

6021

Research Site, Wellington

6500

Research Site, Buenos Aires

9010

Research Site, Aydin

10400

Research Site, Bangkok

10450

Research Site, George Town

11410

Research Site, México, D.F.

16059

Research Site, Bursa

21010

Research Site, Vinnytsia

22332

Research Site, Incheon

22903

Research Site, Charlottesville

26426

Research Site, Wŏnju

26480

Research Site, Eskişehir

30322

Research Site, Atlanta

30341

Research Site, Atlanta

30990

Research Site, Ipoh

32040

Research Site, Seri Manjung

33012

Research Site, Hialeah

33016

Research Site, Hialeah

33021

Research Site, Hollywood

33144

Research Site, Miami

33155

Research Site, Miami

33165

Research Site, Miami

33166

Research Site, Miami Springs

33520

Research Site, Tampere

34000

Research Site, Taiping

Research Site, Durango

34020

Research Site, Istanbul

35210

Research Site, Izmir

35233

Research Site, Daejeon

35330

Research Site, Izmir

38000

Research Site, Celaya

38116

Research Site, Memphis

38119

Research Site, Memphis

41200

Research Site, Klang

41380

Research Site, Kocaeli

44150

Research Site, Guadalajara

45030

Research Site, Manisa

45116

Research Site, Zapopan

49023

Research Site, Dnipro

50586

Research Site, Kuala Lumpur

55139

Research Site, Kurupelit

60123

Research Site, Ancona

62209

Research Site, Cuernavaca

62250

Research Site, Putrajaya

62290

Research Site, Cuernavaca

64460

Research Site, Monterrey

64620

Research Site, Monterrey

67300

Research Site, Kozhikode

70300

Research Site, Seremban

75400

Research Site, Malacca

76230

Research Site, Juriquilla

76800

Research Site, San Juan del Río

78229

Research Site, San Antonio

78503

Research Site, McAllen

78539

Research Site, Edinburg

78550

Research Site, Harlingen

80020

Research Site, Barranquilla

80100

Research Site, Johor Bahru

80138

Research Site, Napoli

80230

Research Site, Culiacán

83404

Research Site, Idaho Falls

88996

Research Site, Kota Kinabalu

89440

Research Site, Ciudad Madero

90110

Research Site, Hat Yai

91900

Research Site, Veracruz

93586

Research Site, Kuching

94290

Research Site, Boca del Rio

95821

Research Site, Sacramento

97000

Research Site, Mérida

125993

Research Site, Moscow

160012

Research Site, Chandigarh

334003

Research Site, Bikaner

380008

Research Site, Ahmedabad

411030

Research Site, Pune

422002

Research Site, Nashik

426009

Research Site, Izhevsk

431003

Research Site, Aurangabad

450000

Research Site, Ufa

500012

Research Site, Hyderabad

531011

Research Site, Visakhapatnam

560002

Research Site, Bangalore

630004

Research Site, Armenia

641009

Research Site, Coimbatore

700054

Research Site, Kolkata

3109601

Research Site, Haifa

7500710

Research Site, Santiago

06519

Research Site, New Haven

07753

Research Site, Neptune City

C1180AAX

Research Site, Buenos Aires

C1119ACN

Research Site, CABA

C1405BCH

Research Site, Ciudad de Buenos Aires

T4000IHE

Research Site, San Miguel de Tucumán

71625-009

Research Site, Brasília

80810-040

Research Site, Curitiba

60170-320

Research Site, Fortaleza

60430-270

Research Site, Fortaleza

99010-080

Research Site, Passo Fundo

90430-001

Research Site, Porto Alegre

91350-250

Research Site, Porto Alegre

14051-104

Research Site, Ribeirão Preto

97015-530

Research Site, Santa Maria

01223-001

Research Site, São Paulo

05652-900

Research Site, São Paulo

H1T 2M4

Research Site, Montreal

00165

Research Site, Roma

06700

Research Site, México

01-868

Research Site, Warsaw

01021

Research Site, Kyiv

B4 6NH

Research Site, Birmingham

E1 1BB

Research Site, London

SE5 9RS

Research Site, London

TS4 3BW

Research Site, Middlesbrough

NG7 2UH

Research Site, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY