Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO)TM

PHASE3CompletedINTERVENTIONAL
Enrollment

175

Participants

Timeline

Start Date

March 20, 2018

Primary Completion Date

October 19, 2022

Study Completion Date

May 31, 2023

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Metformin

At least 1000 mg/day or up to a maximal tolerated dose.

DRUG

Insulin

Basal or multiple dose injection.

DRUG

Placebo

1 film-coated tablet of either Linagliptin or Empagliflozin matched placebo once daily.

DRUG

Linagliptin

1 film-coated tablet Linagliptin once daily, until end of treatment.

DRUG

Empagliflozin

1 film-coated tablet of Empagliflozin once daily, until end of treatment.

Trial Locations (83)

4000

Hospital de Clínicas Pte. Dr. Nicolás Avellaneda, San Miguel de Tucumán

10016

New York University Langone Medical Center, New York

10400

Rajavithi Hospital, Bangkok

10468

Advantage Clinical Trials, The Bronx

13210

SUNY Upstate Medical University, Syracuse

14203

UBMD Pediatrics, Buffalo

16499

Ajou University Hospital, Suwon

17033

Penn State College of Medicine, Hershey

19104

Children's Hospital of Philadelphia, Philadelphia

21287

Johns Hopkins Hospital, Baltimore

22908

University of Virginia Health System, Charlottesville

23219

Children's Hospital of Richmond at VCU, Richmond

27514

The University of North Carolina at Chapel Hill, Chapel Hill

30329

Children's Center for Advanced Pediatrics, Atlanta

30331

Atlanta Center, Atlanta

31096

Rambam Medical Center, Haifa

31217

Investigación en Salud y Metabolismo S.C., Chihuahua City

31904

Columbus Regional Research Institute, Columbus

32514

Nemours Clinic, Pensacola

32789

AdventHealth Medical Group, Pediatric Diabetes and Endocrinology at Winter Park, Winter Park

32825

Pediatric and Adult Research Center, Orlando

33016

Empire Clinical Research, LLC, Miami Lakes

33144

Oceane7 Clinical Research, Miami

33612

University of South Florida, Tampa

37232

Vanderbilt University Medical Center, Nashville

38119

LifeDoc Research, PLLC, Memphis

40002

Srinagarind Hospital, Khon Kaen

40202

Novak Center for Children's Health, Louisville

44106

University Hospitals of Cleveland, Cleveland

45116

Centro de Investigación Médica de Ocidente, S.C., Zapopan

48202

Integrative Biosciences Center, Detroit

52242

University of Iowa Hospitals and Clinics, Iowa City

57701

Monument Health Rapid City Hospital, Inc., Rapid City

64108

Children's Mercy Hospitals and Clinics, Kansas City

72190

Consultorio Medico, Puebla City

73104

University of Oklahoma, Oklahoma City

74135

University of Oklahoma, Tulsa

77089

Office of Amir A. Hassan, MD, P.A., Houston

78207

Texas Diabetes Institute, San Antonio

78560

Saenz Medical Center, La Joya

79106

Universitätsklinikum Freiburg, Freiburg im Breisgau

80020

Centro de Diabetes Cardiovascular IPS, Barranquilla

80045

Children's Hospital Colorado, Aurora

83280

Investigacion Medica Sonora S.C., Sonora

83404

Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls

84101

Soroka Univ. Medical Center, Beersheba

85016

Phoenix Children's Hospital, Phoenix

85724

University of Arizona, Tucson

89440

Centro de Estudios de Investigación Metabólicos y Cardiovasculares, S.C., Ciudad Madero

92123

Rady Children's Hospital - San Diego, San Diego

92868

CHOC Children's Hospital, Orange

94158

University of California San Francisco, San Francisco

94304

Stanford University Medical Center, Palo Alto

110221

Dexa-Diab IPS, Bogotá DC

117036

Endocrinology Scientific Center, MoH and Social Development, Moscow

130021

The First Hospital of Jilin University, Changchun

153040

Ivanovo Reg.Clin.Hosp., Ivanovo

194100

St. Petersburg State Pediatric University, Saint Petersburg

344022

"Fed. State Budget Educational Instit. of Higher Education Rostov State Med. Univ. of MoH of RF", Rostov-on-Don

420012

State Medical University, Kazan, Kazan'

426009

Rep.childrens clin.hosp., Izhevsk

450017

Zhengzhou Children'S Hospital, Zhengzhou

450106

Bahkir state med. Univ. of the Ministry Polyclinic Pediatric, Ufa

610014

"Munic. Instit. of HC Kirov clin. hosp.#7 n.a.V.I.Urlova", Kirov

630091

State Novosibirsk Regional Clinical Hospital, Novosibirsk

634050

Siberian State Med.Uni,Faculty Therapy Dep.w/ Clin.Pharmacol, Tomsk

664049

Regional Clinical Hospital 'The Badge of Honor Order', Irkutsk

5265601

The Chaim Sheba Medical Center Tel HaShomer, Ramat Gan

06511

Yale University School of Medicine, New Haven

02115

Boston Children's Hospital, Boston

02215

Joslin Diabetes Center, Boston

39216-4505

University Of Mississippi Medical Center, Jackson

X5000JHQ

Sanatorio Allende S.A., Nueva Córdoba

60160-230

Instituto de Estudos e Pesquisas Clínicas IEP-CE, Fortaleza

14048-900

Fundacao de Apoio ao Ensino, Pesquisa e Assistencia do Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto, Ribeirão Preto

R3E 3P4

University of Manitoba - Health Sciences Centre, Winnipeg

M5G 1X8

The Hospital for Sick Children, Toronto

06760

CAIMED Investigacion en Salud, S.A. de C.V., Mexico City

00726

San Juan Bautista School of Medicine, Caguas

03722

Severance Hospital, Seoul

05505

Asan Medical Center, Seoul

SW17 0QT

St George's Hospital, London

RG1 5AN

Royal Berkshire Hospital, Reading

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY