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NCT00894868 Clinical Trial

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

Congestive Heart Failure Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00894868
Other study ID # CLAF237A23118
Secondary ID 2008-005012-41
Status Completed
Phase Phase 4
First received
Last updated
Start date May 2009
Est. completion date August 2012

Study information
Verified date April 2014
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 798
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• vildagliptin

• placebo of vildagliptin

Locations
Country Name City State
Czechia Novartis Investigative Site Benesov Czech Republic
Czechia Novartis Investigative Site Broumov
Czechia Novartis Investigative Site Havirov Czech Republic
Czechia Novartis Investigative Site Litomysl Czech Republic
Czechia Novartis Investigative Site Pardubice
Czechia Novartis Investigative Site Praha 2 CZE
Czechia Novartis Investigative Site Praha 4 Czech Republic
Denmark Novartis Investigative Site Copenhagen NV
Denmark Novartis Investigative Site Copenhagen S
Denmark Novartis Investigative Site Frederiksberg
Denmark Novartis Investigative Site Hellerup
Denmark Novartis Investigative Site Roskilde
Denmark Novartis Investigative Site Slagelse
Estonia Novartis Investigative Site Pärnu
Estonia Novartis Investigative Site Tallinn
Estonia Novartis Investigative Site Tallinn
Estonia Novartis Investigative Site Tartu
Germany Novartis Investigative Site Alsdorf
Germany Novartis Investigative Site Bad Oeynhausen
Germany Novartis Investigative Site Dresden
Germany Novartis Investigative Site Fulda
Germany Novartis Investigative Site Kamp-Lintfort
Germany Novartis Investigative Site Saarlouis
Germany Novartis Investigative Site Senden
Greece Novartis Investigative Site Alexandroupolis
Greece Novartis Investigative Site Chios
Greece Novartis Investigative Site Thessaloniki
Guatemala Novartis Investigative Site Guatemala City
Guatemala Novartis Investigative Site Guatemala City
India Novartis Investigative Site Ahmedabad Gujarat
India Novartis Investigative Site Bangalore Karnataka
India Novartis Investigative Site Indore Madhya Pradesh
India Novartis Investigative Site Jaipur Rajasthan
India Novartis Investigative Site Lucknow Uttar Pradesh
India Novartis Investigative Site Ludhiana Punjab
India Novartis Investigative Site Mangalore Karnataka
India Novartis Investigative Site Nagpur Maharashtra
India Novartis Investigative Site New Delhi Delhi
India Novartis Investigative Site Secunderabad Andhra Pradesh
India Novartis Investigative Site Trivandrum Kerala
India Novartis Investigative Site Vadodara Gujrat
India Novartis Investigative Site Visakhapatnam Andhra Pradesh
India Novartis Investigative Site Vishakhapatnam Andhra Pradesh
Italy Novartis Investigative Site Bergamo BG
Italy Novartis Investigative Site Firenze FI
Italy Novartis Investigative Site Mercato San Severino SA
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Novara
Italy Novartis Investigative Site Passirana Di Rho MI
Italy Novartis Investigative Site Pavia PV
Italy Novartis Investigative Site Siena SI
Latvia Novartis Investigative Site Daugavpils
Latvia Novartis Investigative Site Preili
Lithuania Novartis Investigative Site Alytus
Lithuania Novartis Investigative Site Kaunas
Lithuania Novartis Investigative Site Vilnius
Lithuania Novartis Investigative Site Vilnius
Poland Novartis Investigative Site Gdansk
Poland Novartis Investigative Site Klodzko
Poland Novartis Investigative Site Warsawa
Poland Novartis Investigative Site Wroclaw
Romania Novartis Investigative Site Baia-Mare Maramures
Romania Novartis Investigative Site Brasov
Romania Novartis Investigative Site Bucharest District 2
Romania Novartis Investigative Site Craiova Jud. Dolj
Russian Federation Novartis Investigative Site Kaliningrad
Russian Federation Novartis Investigative Site Kazan
Russian Federation Novartis Investigative Site Krasnodar
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site N.Novgorod
Russian Federation Novartis Investigative Site Nizhny Novgorod
Russian Federation Novartis Investigative Site Penza
Russian Federation Novartis Investigative Site Petrozavodsk
Russian Federation Novartis Investigative Site Saint-Petersburg
Russian Federation Novartis Investigative Site Saint-Petersburg
Russian Federation Novartis Investigative Site Samara
Russian Federation Novartis Investigative Site Saratov
Russian Federation Novartis Investigative Site Saratov
Russian Federation Novartis Investigative Site St. Petersburg
Russian Federation Novartis Investigative Site St.- Petersburg
Singapore Novartis Investigative Site Singapore
Singapore Novartis Investigative Site Singapore
Slovakia Novartis Investigative Site Banska Bystrica
Slovakia Novartis Investigative Site Dunajska Streda Slovak Republic
Slovakia Novartis Investigative Site Komarno
Slovakia Novartis Investigative Site Kosice
Slovakia Novartis Investigative Site Lucenec
Slovakia Novartis Investigative Site Modava Nad Bodvou
Slovakia Novartis Investigative Site Nitra Slovak Republic

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Czechia,  Denmark,  Estonia,  Germany,  Greece,  Guatemala,  India,  Italy,  Latvia,  Lithuania,  Poland,  Romania,  Russian Federation,  Singapore,  Slovakia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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). 52 weeks
Secondary 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. 52 weeks
Secondary 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. 52 weeks
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