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Diabetes Mellitus, Type 2Phase 2/3NCT00860288

Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

A Phase 2/3 study testing Vildagliptin, Metformin and Sitagliptin in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 187 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as add-on therapy to metformin Read more about this study

Who is it for?
Ages 18 to 78 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Vildagliptin, Metformin and Sitagliptin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,988 participants
Where
187 sitesin 21 countries
Study dates
Feb 2009to Mar 2011
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 78 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients 18-78 years old inclusive at Visit 1
  • T2DM patients treated with metformin for at least 3 months and a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to Visit 1
  • Patient agreement to maintain same dose of metformin throughout study
  • HbA1c of ≥ 7.0 and ≤ 9.5 % at Visit 1
  • Body Mass Index (BMI) in the range of 22-45 kg/m2 at visit 1

Who cannot join

  • Pregnant or nursing (lactating) women
  • FPG ≥ 270 mg/dL ( ≥ 15.0 mmol/L)

Trial locations and contacts

187 sites in 21 countries.

187 sites in 21 countries

Germany51 sites

  • Internistische Gemeinschaftspraxis Nagel, Dietlein & Hunstiger

    Augsburg, 86150

  • Praxis Dr. Med. Kurt Rack

    Augsburg, 86150

  • Gemeinschaftspraxis S. Maxeiner/Dr. Behr/S. Rupprecht

    Bad Kreuznach, 55545

  • Klinische Forschung Berlin-Buch

    Berlin, 10117

  • Praxis Dr. Med. Ulrike Venschott-Jordan

    Berlin, 12247

  • Praxis Dr. Med. Monika Kiper

    Berlin, 12347

  • Praxis Dr. Med. Christina Bondke

    Berlin, 13189

  • Bibertal Klinik

    Bibertal, 89346

  • Praxis Dr. Med. Claudia Ulbrich

    Cologne, 50823

  • Gemeinschaftspraxis Dr. med. Ali Boustani

    Diez, 65582

  • Facharzt fuer Allgemeinmedizin

    Dorsten, 46282

  • Praxis Dr. Med. Anwar Ansari

    Einbeck, 37574

  • Hausaerzte am Stern Dr. Med. Blume / Dr. Med. Garanin

    Essen, 45130

  • Praxis Dr. Med. Roland Kutzke

    Essen, 45144

  • Praxis Dr. Med. Thorsten Rau

    Essen, 45276

  • Praxis Dr. Med. Joerg Luedemann / Facharzt fuer Innere Medizin - Diabetologie

    Falkensee, 14612

  • Praxis Dr. Med. Daniela Freise

    Frankfurt, 60599

  • Dial.-Med. Kerstin Steinbach

    Freital, 01705

  • Gemeinschaftspraxis

    Fulda, 36037

  • Praxis Dr. Med. Wolfgang Krause

    Grimma, 04668

  • Krankenhaus Hagenow, Innere Medizin

    Hagenow, 19230

  • MVZ-medicum Hamburg

    Hamburg, 20097

  • Diabetes-Zentrum Wandsbek

    Hamburg, 22041

  • Gemeinschaftspraxis Dr. Grüneberg, Dr.Mehring, Bitterer-Tölle

    Herne, 44653

  • Praxis Dr. Med. Helmut Anderten

    Hildesheim, 31139

  • Praxis Dr. Med. Juergen Landschulze

    Kahla, 07768

  • Praxis Dr. Med. Julia Chevts

    Karlsruhe, 76199

  • Praxis Dr. Med. Hans-Helmut Seibert

    Kassel, 34125

  • Dres. Klein/Minnich

    Künzing, 94550

  • Praxis Dr. Med. Birgit Hoene

    Leipzig

  • Pro Scientia med

    Lübeck, 23562

  • Diabetes Schwerpunktpraxis

    Meissen, 01662

  • Praxis Dres. Prohaska / Lindner

    Mühldorf, 84453

  • Praxis Dr. Med. Claus-Michael Grimm

    München, 81373

  • Praxis Dr. Fischer & Dr. Keuthage

    Münster, 48153

  • Gemeinschaftspraxis Dr. Uwe Böckmann/Dr. med. Maren Molkewehrum

    Neumünster, 24534

  • Praxis Dr. Med. Joachim Etter

    Oberhausen, 46049

  • IkFE Studiencenter Potsdam GMBH i.G.

    Potsdam, 14469

  • Diabetes Center Quakenbrueck

    Quakenbrück, 49610

  • Praxis Dr. Altwicker, Dr. Kanis

    Reinfeld, 23858

  • Praxis Dr. Med. Ulrich Aigner

    Rothenburg

  • Praxis Dr. Med. Sabine Sedl

    Schönberg, 23923

  • Dres. Hiltensperger & Schaal

    Schrobenhausen, 86529

  • Praxis Hans-Joachim Herrmann/Dr. med. B. Bauer

    Schwabenheim, 55270

  • Praxis Dr. Med. Ottmar Herfert

    Stuttgart, 70469

  • Praxis Dr. Med. Doru Popa

    Veitsbronn, 90587

  • Gemeinschaftspraxis Gerhard Steinmaier und Dr. Med. Werner Bauer

    Viernheim, 68519

  • Gemeinschaftspraxis Sauter

    Wangen, 88239

  • Praxis Dr. Med. Rudolf Matthias Remppis

    Weißenhorn, 89264

  • Praxis Dr. Med. Peter Genthner

    Welzheim, 73642

  • Gemeinschaftspraxis Dr. med. Reinhold Schneider und Christine Schneider

    Wetzlar, 35584

Other trials in Germany

Italy20 sites

  • U.O.C. di Diabetologia e Malattie Metaboliche

    Arenzano

  • U.S.C. di Endocrinologia (Ingresso 13 - piano 2) Dip. di Medicina

    Bergamo

  • U.O.C. Diabetologia Endocrinologia Dip. Medico

    Campobasso

  • U.O. Medicina Generale

    Casorate Primo

  • I Divisione Medicina

    Catania

  • U.O. Malattie Metaboliche e Diabetologia

    Chieri

  • U.O.C. di Medicina d'Urgenza e Pronto Soccorso

    Cosenza

  • Servizio Diabetologia, SOD Cardiologia Geriatrica - D.A.I. del Cuore e dei Vasi

    Florence

  • Centro Diabetologico Malattie Metaboliche

    Mercato San Severino

  • Divisione Malattie Metaboliche e Diabetologia

    Milan

  • S. Semplice Dip. di Endocrinologia e Diabetologia Dip. di Medicina Interna

    Milan

  • U.O. Medicina II - Dip. Medicina Interna

    Milan

  • Unità Cardio-Metabolica e Trials Clinici Dipartimento di Medicina Interna

    Milan

  • U.O. Diabetologia

    Olbia

  • Centro per l'Aterosclerosi Dip. di Medicina Interna

    Roma

  • U.O. Endocrinologia e Diabetologia

    Roma

  • U.O.C. di Diabetologia c/o AUSL ROMA B - Sede Territoriale

    Roma

  • U.O.C. di Medicina Interna B - BMI02 Dip. Scienze Cliniche - II Clinica Medica

    Roma

  • S. S. di Diabetologia Dip. Med. Interna e Malattie Metaboliche

    Siena

  • S.C. Prevenzione-Riabilitazione Cardiologica presso ex-Dispensario

    Vibo Valentia

Other trials in Italy

Slovakia10 sites

  • MEDISPEKTRUM s.r.o,

    Bratislava, Slovak Republic, 811 02

  • Diabetologicka ambulancia,

    Bratislava, Slovakia Republic, 81272

  • Diametabol.s.r.o.,

    Bratislava, 821 07

  • Diabetologicka ambulancia

    Košice, Slovakia Republic, 040 01

  • Diabetologicka ambulancia,

    Lučenec, Slovakia Republic, 984 01

  • NZZ Diabetologicka ambulancia

    Nové Zámky, Slovakia Republic, 940 01

  • MUDr. Margita Kiripolska s.r.o

    Považská Bystrica, 017 01

  • .Interna klinika, FN J.A. Reimana

    Prešov, Slovak Republic, 081 81

  • Diabetes centrum s.r.o

    Trenčín, Slovakia Republic, 911 01

  • Diabetologicka ambulancia,

    Žilina, Slovakia Republic, 010 01

Other trials in Slovakia

Hungary9 sites

  • Szent Margit Hospita

    Budapest, 1032

  • Károlyi Sándor Hospital

    Budapest, 1041

  • Szent Imre Hospital

    Budapest, 1115

  • Konszenzusplusz Kft.

    Csongrád, 6640

  • Petz Aladar Hospital

    Győr, 9023

  • Jósa Andras Hospital

    Nyíregyháza

  • Szte-Áok I

    Szeged, 6720

  • Balassa Janos Hospital

    Szekszárd, 7100

  • Zala Megyei Hospital

    Zalaegerszeg, 8900

Other trials in Hungary

India9 sites

  • Manipal Hospital,

    Bangalore, Karantaka, 560 017

  • Madras Diabetes Research Foundation

    Chennai, Tamil Nadu, 500 082

  • M. V. Hosp for Diabetes P. Ltd. 4,

    Chennai, 13

  • Medicity Hospital

    Hyderabaad, 500 036

  • Nizam's institute of medical sciences,

    Hyderabaad, 500 082

  • Diabetes Thyroid Hormone Research Institute Pvt Ltd.

    Indore, Madhya Pradesh, 452001

  • S. R. Kalla Memorial gastro and general hosp,

    Jaipur, 302001

  • Health and Research Centre

    Trivandrum, Kerala, 695 001

  • Christian Medical College,

    Vellore, P. O. Box. No. 3.

Other trials in India

Finland8 sites

  • Lihavuustutkimusyksikkö

    Helsinki, 2 A 2 00270

  • Mehiläinen Töölö Diabetesklinikka

    Helsinki, 47 A 00260

  • Terveystalo Kuopio

    Kuopio, 70100

  • Mehiläinen Lahti

    Lahti, 6 C 15110

  • ODL Terveys Oy, Tutkimusyksikkö,

    Oulu, 90100

  • Mehiläinen Riihimäki

    Riihimäki, 11130

  • Terveystalo Tampereen työterveys Kalmar

    Tampere, 33900

  • Myyrmäen terveysasema

    Vantaa, 01600

Other trials in Finland

Latvia7 sites

  • Daugavpils Regional Hospital

    Daugavpils, 5417

  • Primary Health Centre of Jaunliepaja

    Liepāja, 3401

  • Private practice of endocrinology

    Ogre, 5001

  • Center of Endocrinology

    Riga, 1002

  • Riga Outpatient Clinic "Dziednieciba"

    Riga, 1057

  • Talsi Clinical Hospital

    Talsi, 3201

  • Endocrinology Department of Vidzemes Hospital

    Valmiera, 4201

Other trials in Latvia

Lithuania7 sites

  • JSC "Klinikiniai sprendimai"

    Alytus, 63257

  • Kaunas District Hospital

    Kaunas, 45130

  • Kaunas Silainiai Outpatient Clinic

    Kaunas, 48259

  • Kaunas Medical University Hospital

    Kaunas, 50009

  • Kaunas Dainavos Outpatient Clinic

    Kaunas, 51270

  • Vilnius University Hospital Santariskiu Clinics

    Vilnius, 08661

  • Private Endocrinology Clinic

    Vilnius, 09112

Other trials in Lithuania

Romania7 sites

  • CMI Cardiologie "Dr. Pop Calin Florin"

    Baia Mare, ap. 72

  • "C. I. Parhon" Endocrinology Institute

    Bucharest, district 1

  • Medical Centre "Sanatatea Ta" SRL

    Bucharest, district 2

  • Medical Practice SRL

    Oradea, ap. 3

  • Anamed SRL

    Oradea, ap. 5

  • Emergency County Hospital Ploiesti

    Ploieşti, no. 100

  • Policlinica "Dr. Citu"

    Timișoara, no. 27

Other trials in Romania

Argentina6 sites

  • Instituto de Investigaciones Biomedicas

    Buenos Aires, Santa Fe Province, 3000FNF

  • Grupo Medico Alem

    Buenos Aires, B1642DCD

  • DIM Clinical Privada

    Buenos Aires, B1704ETD

  • Clinica Medica Sin Internacion

    Buenos Aires, B1824KAJ

  • Fundación de Estudios Farmacológicos y de Medicamentos

    Buenos Aires, C1027AAP

  • Grupo Colaborative Rosario

    Rosario, Santa Fe Province, S2002OJP

Other trials in Argentina

Austria6 sites

  • Universitaetsklinik Graz medizinische Universitaetsklinik;

    Graz, 8036

  • LKH Salzburg Landesklinik fuer Innere Medizin I

    Salzburg, 5020

  • Millergasse 7

    Vienna, 1060

  • Hanusch Krankenhaus 1. Med. Abteilung und Nephrodepartment

    Vienna, 1140

  • Kindlergasse 4

    Wiener Neustadt, 2700

  • Kindlergasse 4

    Wiener Neustadt

Other trials in Austria

Belgium6 sites

  • Private Practice Cardiology (Dr. Hollanders)

    De Pinte, 9840

  • Private Practice (Vernijns)

    Genk, 3600

  • Private Practice (Dr. De Meulemeester)

    Gozée, 6534

  • Huisartsenpraktijk Hygeia

    Hasselt, 3500

  • Private Practice (Dr. Jaak Mortelmans)

    Oostham, 3945

  • Private Practice Diabetology (Dr. Coucke)

    Sint-Gillis-Waas, Sint-Niklaasstraat 117, 9170

Other trials in Belgium

Guatemala6 sites

  • Clínica y Hospital Colón del Paciente Diabético

    Guatemala City, 01001

  • Endonutri S.A

    Guatemala City, 01010

  • Clínica y Hospital Colón del Paciente Diabético

    Guatemala City, 11-49

  • Clinica Dr. Erick Turcios

    Guatemala City, Oficina 1114

  • Endonutri S. A.

    Guatemala City, Oficina 909

  • Clinica Dr. Sergio Bran

    Guatemala City

Other trials in Guatemala

Norway6 sites

  • Flattum legesenter

    Hønefoss, 3503

  • Randesund Helsesenter

    Kristiansand

  • Sinsenklinikken

    Oslo, 0580

  • Oslo Universitetssykehus

    Oslo

  • Hinnastrekanten legekontor

    Stavanger, 4020

  • Vennesla legesenter

    Vennesla

Other trials in Norway

Peru6 sites

  • Clinica San Miguel

    Arequipa

  • Clinica Geriatrica Militar

    Lima

  • Clinica San Borja

    Lima

  • Clinica Senor de los Milagros

    Lima

  • Hospital Nacional Cayetano Heredia

    Lima

  • Hospital Nacional Guillermo Almenara Irigoyen

    Lima

Other trials in Peru

Mexico5 sites

  • Unidad Metabolica y Cardiovascular S.C.

    Cuernavaca, Morelos

  • Clínica de Diabetes de la Secretaria de Salud de Durango

    Durango, 34070

  • Comité Bioetico para la Investigación Clínica S.C.

    Mexico City, Durango, 03300

  • Clínica Eugenio Sue

    Mexico City, Polanco Chapultepec, 11550

  • Arke Estudios Clinicos S.A. de C.V.

    Mexico City, 06700

Other trials in Mexico

Poland5 sites

  • Bydgoskie Centrum Diabetologii i Endokrynologii

    Bydgoszcz, 85 822

  • NZOZ "Specjalista" Sp z o. o.

    Kutno, 99 300

  • Oddzial Chorob Wewnetrznych

    Mielec, 39 300

  • Poradnia Lekarza Rodzinnego

    Poznan, 60 521

  • Poznański Ośrodek Medyczny "NOVAMED"

    Poznan, 60 773

Other trials in Poland

South Korea5 sites

  • Eulji General Hospital

    Seoul

  • Kangbuk Samsung Medical center

    Seoul

  • Korea University Guro Hospital

    Seoul

  • The Catholic University of Korea Holy Family Hospital

    Seoul

  • Ajou university hospital

    Suwon

Other trials in South Korea

Greece3 sites

  • Laiko General Hospital,

    Athens, GR11527

  • Lamia General Hospital

    Larissa, GR 35100

  • Papageorgiou General Hospital

    Thessaloniki, GR56403

Other trials in Greece

Venezuela3 sites

  • Hospital Militar Dr Carlos Arvelo. Final Av. José Angel Lamas. Servicio de Endocrinología.

    Caracas, Piso 4. Urb.

  • Hospital Dr Miguel Perez Carreño. Servicio de Endocrinología. Sotano.

    Caracas

  • Ambulatorio Militar Tipo III Paramacay. Avenida Universidad. Sector Santa Ana. Naguanagua.

    Valencia, Carabobo

Other trials in Venezuela

Israel2 sites

  • Maccabi Healthcare Services

    Rishon LeZiyyon, 75650

  • Ziv Medical Center

    Safed, 13100

Other trials in Israel

About this study

This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as add-on therapy to metformin

Being tested
Vildagliptin, Metformin, Placebo, Sitagliptin
Keywords
Type 2 Diabetes, vildagliptin
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00860288
Study groupRoleWhat they receive
Vildagliptin Dose 1ExperimentalNot described
Receives: Drug: Vildagliptin; Drug: Metformin
Vildagliptin Dose 2ExperimentalNot described
Receives: Drug: Vildagliptin; Drug: Metformin
PlaceboPlacebo comparatorNot described
Receives: Drug: Metformin; Drug: Placebo
SitagliptinActive comparatorNot described
Receives: Drug: Metformin; Drug: Sitagliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment

    Measured: 24 weeks

Secondary outcomes (7)

  1. To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of sitagliptin added to metformin after 24 weeks of treatment.

    Measured: 24 weeks

  2. To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in fasting plasma glucose with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment.

    Measured: 24 weeks

  3. To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in fasting plasma glucose with vildagliptin added to metformin to that of sitagliptin added to metformin.

    Measured: 24 weeks

  4. To evaluate the safety and tolerability of vildagliptin compared to placebo and sitagliptin over 24 weeks of treatment as add-on therapy to metformin in patients with T2DM.

    Measured: 24 weeks

  5. To evaluate the long-term safety and tolerability of vildagliptin compared to sitagliptin over the entire study duration as add-on therapy to metformin in patients with T2DM.

    Measured: 76 weeks

  6. To evaluate the body weight change from baseline with vildagliptin compared to placebo and sitagliptin after 24 weeks of treatment as add-on therapy to metformin in patients with T2DM.

    Measured: 24 weeks

  7. To evaluate the long-term efficacy of vildagliptin compared to sitagliptin over the entire study duration as add-on therapy to metformin in patients with T2DM.

    Measured: 76 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionMar 2011
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,988 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00860288
Sponsor's protocol ID
CLAF237B2224
Status last verified
Jan 2013
First submitted
10 Mar 2009
Last updated
29 Dec 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Vildagliptin, Metformin and Sitagliptin in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 187 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 187 sites in Germany, Italy, Slovakia, Hungary, India and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00860288.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.

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Clinical Trial NCT00860288 | AzTrials