Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure

NCT ID: NCT00894868

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

798 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-08-31

Brief Summary

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This study will assess the effect of vildagliptin on left ventricular function in patients with type 2 diabetes and congestive heart failure (NYHA Class I-III). Effect on HbA1c and overall safety and tolerability will also be assessed.

Detailed Description

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Conditions

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Congestive Heart Failure Type II Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vildagliptin

Group Type EXPERIMENTAL

vildagliptin

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

placebo of vildagliptin

Intervention Type DRUG

Interventions

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vildagliptin

Intervention Type DRUG

placebo of vildagliptin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with T2DM, diagnosed at least 3 months prior to Visit 1
* CHF (NYHA Class I, Class II, or Class III) at Visit 1
* LVEF \< 40%

Exclusion Criteria

* Pregnant or lactating female
* FPG ≥ 270 mg/dL (≥15 mmol/L)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Benešov, Czech Republic, Czechia

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Havířov, Czech Republic, Czechia

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Litomyšl, Czech Republic, Czechia

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Prague, Czech Republic, Czechia

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Prague, CZE, Czechia

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Broumov, , Czechia

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Pardubice, , Czechia

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Copenhagen NV, , Denmark

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Copenhagen S, , Denmark

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Frederiksberg, , Denmark

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Hellerup, , Denmark

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Roskilde, , Denmark

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Slagelse, , Denmark

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Pärnu, , Estonia

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Tallinn, , Estonia

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Tallinn, , Estonia

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Tartu, , Estonia

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Alsdorf, , Germany

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Bad Oeynhausen, , Germany

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Dresden, , Germany

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Fulda, , Germany

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Kamp-Lintfort, , Germany

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Saarlouis, , Germany

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Senden, , Germany

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Alexandroupoli, , Greece

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Chios, , Greece

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Thessaloniki, , Greece

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Guatemala City, , Guatemala

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Guatemala City, , Guatemala

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Secunderabad, Andhra Pradesh, India

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Visakhapatnam, Andhra Pradesh, India

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Ahmedabad, Gujarat, India

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Vadodara, Gujarat, India

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Bangalore, Karnataka, India

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Mangalore, Karnataka, India

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Trivandrum, Kerala, India

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Indore, Madhya Pradesh, India

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Nagpur, Maharashtra, India

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New Delhi, National Capital Territory of Delhi, India

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Ludhiana, Punjab, India

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Jaipur, Rajasthan, India

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Lucknow, Uttar Pradesh, India

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Bergamo, BG, Italy

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Florence, FI, Italy

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Milan, MI, Italy

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Passirana Di Rho, MI, Italy

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Pavia, PV, Italy

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Mercato San Severino, SA, Italy

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Siena, SI, Italy

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Novara, , Italy

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Daugavpils, , Latvia

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Preiļi, , Latvia

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Alytus, , Lithuania

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Kaunas, , Lithuania

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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Gdansk, , Poland

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Kłodzko, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Bucharest, District 2, Romania

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Craiova, Jud. Dolj, Romania

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Baia Mare, Maramureş, Romania

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Brasov, , Romania

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Kaliningrad, , Russia

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Kazan', , Russia

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Krasnodar, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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N.Novgorod, , Russia

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Nizhny Novgorod, , Russia

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Penza, , Russia

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Petrozavodsk, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

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Saratov, , Russia

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Saratov, , Russia

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Singapore, , Singapore

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Singapore, , Singapore

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Dunajská Streda, Slovak Republic, Slovakia

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Nitra, Slovak Republic, Slovakia

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Banská Bystrica, , Slovakia

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Komárno, , Slovakia

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Košice, , Slovakia

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Lučenec, , Slovakia

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Modava Nad Bodvou, , Slovakia

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Countries

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Czechia Denmark Estonia Germany Greece Guatemala India Italy Latvia Lithuania Poland Romania Russia Singapore Slovakia

References

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McMurray JJV, Ponikowski P, Bolli GB, Lukashevich V, Kozlovski P, Kothny W, Lewsey JD, Krum H; VIVIDD Trial Committees and Investigators. Effects of Vildagliptin on Ventricular Function in Patients With Type 2 Diabetes Mellitus and Heart Failure: A Randomized Placebo-Controlled Trial. JACC Heart Fail. 2018 Jan;6(1):8-17. doi: 10.1016/j.jchf.2017.08.004. Epub 2017 Oct 11.

Reference Type DERIVED
PMID: 29032139 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=9563

Results for CLAF237A23118 from the Novartis Clinical Trials website

Other Identifiers

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2008-005012-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLAF237A23118

Identifier Type: -

Identifier Source: org_study_id

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