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

December 11, 2020 updated by: Novartis Pharmaceuticals

A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of 52 Weeks Treatment With Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

798

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Broumov, Czechia, 550 01
        • Novartis Investigative Site
      • Pardubice, Czechia, 53002
        • Novartis Investigative Site
    • CZE
      • Praha 2, CZE, Czechia, 128 08
        • Novartis Investigative Site
    • Czech Republic
      • Benesov, Czech Republic, Czechia, 25601
        • Novartis Investigative Site
      • Havirov, Czech Republic, Czechia, 736 01
        • Novartis Investigative Site
      • Litomysl, Czech Republic, Czechia, 570 14
        • Novartis Investigative Site
      • Praha 4, Czech Republic, Czechia, 140 00
        • Novartis Investigative Site
  • Denmark
      • Copenhagen NV, Denmark, DK-2400
        • Novartis Investigative Site
      • Copenhagen S, Denmark, DK-2300
        • Novartis Investigative Site
      • Frederiksberg, Denmark, DK-2000
        • Novartis Investigative Site
      • Hellerup, Denmark, DK-2900
        • Novartis Investigative Site
      • Roskilde, Denmark, DK-4000
        • Novartis Investigative Site
      • Slagelse, Denmark, DK-4200
        • Novartis Investigative Site
  • Estonia
      • Pärnu, Estonia, 80018
        • Novartis Investigative Site
      • Tallinn, Estonia, 10138
        • Novartis Investigative Site
      • Tallinn, Estonia, 13415
        • Novartis Investigative Site
      • Tartu, Estonia, 50410
        • Novartis Investigative Site
  • Germany
      • Alsdorf, Germany, 52477
        • Novartis Investigative Site
      • Bad Oeynhausen, Germany, 32545
        • Novartis Investigative Site
      • Dresden, Germany, 01307
        • Novartis Investigative Site
      • Fulda, Germany, 36037
        • Novartis Investigative Site
      • Kamp-Lintfort, Germany, 47475
        • Novartis Investigative Site
      • Saarlouis, Germany, 66740
        • Novartis Investigative Site
      • Senden, Germany, 48308
        • Novartis Investigative Site
  • Greece
      • Alexandroupolis, Greece, GR 68100
        • Novartis Investigative Site
      • Chios, Greece, 82100
        • Novartis Investigative Site
      • Thessaloniki, Greece, 57001
        • Novartis Investigative Site
  • Guatemala
      • Guatemala City, Guatemala, 01010
        • Novartis Investigative Site
      • Guatemala City, Guatemala, 01011
        • Novartis Investigative Site
  • India
    • Andhra Pradesh
      • Secunderabad, Andhra Pradesh, India, 500003
        • Novartis Investigative Site
      • Visakhapatnam, Andhra Pradesh, India, 530002
        • Novartis Investigative Site
      • Vishakhapatnam, Andhra Pradesh, India, 530002
        • Novartis Investigative Site
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Novartis Investigative Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380014
        • Novartis Investigative Site
    • Gujrat
      • Vadodara, Gujrat, India, 390015
        • Novartis Investigative Site
    • Karnataka
      • Bangalore, Karnataka, India, 560078
        • Novartis Investigative Site
      • Mangalore, Karnataka, India, 575002
        • Novartis Investigative Site
    • Kerala
      • Trivandrum, Kerala, India, 695011
        • Novartis Investigative Site
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452010
        • Novartis Investigative Site
    • Maharashtra
      • Nagpur, Maharashtra, India, 440012
        • Novartis Investigative Site
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Novartis Investigative Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302001
        • Novartis Investigative Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • Novartis Investigative Site
  • Italy
      • Novara, Italy, 28100
        • Novartis Investigative Site
    • BG
      • Bergamo, BG, Italy, 24128
        • Novartis Investigative Site
    • FI
      • Firenze, FI, Italy, 50143
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20132
        • Novartis Investigative Site
      • Passirana Di Rho, MI, Italy, 20017
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italy, 27100
        • Novartis Investigative Site
    • SA
      • Mercato San Severino, SA, Italy, 84085
        • Novartis Investigative Site
    • SI
      • Siena, SI, Italy, 53100
        • Novartis Investigative Site
  • Latvia
      • Daugavpils, Latvia, LV-5401
        • Novartis Investigative Site
      • Preili, Latvia, LV-5301
        • Novartis Investigative Site
  • Lithuania
      • Alytus, Lithuania, LT-62381
        • Novartis Investigative Site
      • Kaunas, Lithuania, 50009
        • Novartis Investigative Site
      • Vilnius, Lithuania, LT-08661
        • Novartis Investigative Site
      • Vilnius, Lithuania, LT-05261
        • Novartis Investigative Site
  • Poland
      • Gdansk, Poland, 80-847
        • Novartis Investigative Site
      • Klodzko, Poland, 57-300
        • Novartis Investigative Site
      • Warsawa, Poland, 04-761
        • Novartis Investigative Site
      • Wroclaw, Poland, 50-981
        • Novartis Investigative Site
  • Romania
      • Brasov, Romania, 500173
        • Novartis Investigative Site
    • District 2
      • Bucharest, District 2, Romania, 021382
        • Novartis Investigative Site
    • Jud. Dolj
      • Craiova, Jud. Dolj, Romania, 200147
        • Novartis Investigative Site
    • Maramures
      • Baia-Mare, Maramures, Romania, 430071
        • Novartis Investigative Site
  • Russian Federation
      • Kaliningrad, Russian Federation, 236016
        • Novartis Investigative Site
      • Kazan, Russian Federation, 420012
        • Novartis Investigative Site
      • Krasnodar, Russian Federation, 350072
        • Novartis Investigative Site
      • Moscow, Russian Federation, 127473
        • Novartis Investigative Site
      • Moscow, Russian Federation, 129110
        • Novartis Investigative Site
      • Moscow, Russian Federation, 121552
        • Novartis Investigative Site
      • Moscow, Russian Federation, 117997
        • Novartis Investigative Site
      • Moscow, Russian Federation, 113093
        • Novartis Investigative Site
      • Moscow, Russian Federation, 119048
        • Novartis Investigative Site
      • N.Novgorod, Russian Federation, 603126
        • Novartis Investigative Site
      • Nizhny Novgorod, Russian Federation, 603018
        • Novartis Investigative Site
      • Penza, Russian Federation, 440026
        • Novartis Investigative Site
      • Petrozavodsk, Russian Federation, 185019
        • Novartis Investigative Site
      • Saint-Petersburg, Russian Federation, 197341
        • Novartis Investigative Site
      • Saint-Petersburg, Russian Federation, 193312
        • Novartis Investigative Site
      • Samara, Russian Federation, 443067
        • Novartis Investigative Site
      • Saratov, Russian Federation, 410012
        • Novartis Investigative Site
      • Saratov, Russian Federation, 410031
        • Novartis Investigative Site
      • St. Petersburg, Russian Federation, 198013
        • Novartis Investigative Site
      • St.- Petersburg, Russian Federation, 199034
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119074
        • Novartis Investigative Site
      • Singapore, Singapore, 168752
        • Novartis Investigative Site
  • Slovakia
      • Banska Bystrica, Slovakia, 974 01
        • Novartis Investigative Site
      • Komarno, Slovakia, 945 01
        • Novartis Investigative Site
      • Kosice, Slovakia, 040 01
        • Novartis Investigative Site
      • Lucenec, Slovakia, 98439
        • Novartis Investigative Site
      • Modava Nad Bodvou, Slovakia, 045 01
        • Novartis Investigative Site
    • Slovak Republic
      • Dunajska Streda, Slovak Republic, Slovakia, 929 01
        • Novartis Investigative Site
      • Nitra, Slovak Republic, Slovakia, 949 01
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo of vildagliptin
Experimental: Vildagliptin
Drug: vildagliptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the effect of vildagliptin on left ventricular function in patients with T2DM and CHF (NYHA class I-III) by showing that vildagliptin is at least not inferior to placebo with respect to change in left ventricular ejection fraction (LVEF).
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the overall safety of vildagliptin versus placebo in patients with T2DM and CHF (NYHA class I - III) over 52 weeks of treatment with special regard to signs and symptoms of heart failure.
Time Frame: 52 weeks
52 weeks
To evaluate the efficacy of vildagliptin in patients with T2DM and CHF (NYHA class I-III) by assessing the HbA1c reduction with vildagliptin compared to placebo after 16 weeks of treatment.
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

May 6, 2009

First Submitted That Met QC Criteria

May 6, 2009

First Posted (Estimate)

May 7, 2009

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAF237A23118
  • 2008-005012-41 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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