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

NCT00894868 | Completed Phase 4

• 2 other identifiers: CLAF237A231182008-005012-41
• Study Type: interventional
• Target: 798
• Locations: 15 countries
• Sites: 93

Brief 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.

Conditions

Congestive Heart Failure; Type II Diabetes Mellitus

Keywords

Congestive Heart Failure; CHF, vildagliptin; metabolic disease; cardiovascular disease; T2DM

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

Vildagliptin

EXPERIMENTAL

Drug: vildagliptin

Placebo

PLACEBO COMPARATOR

Drug: placebo of vildagliptin

Interventions

vildagliptin DRUG

Vildagliptin

placebo of vildagliptin DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• Pregnant or lactating female
• FPG ≥ 270 mg/dL (≥15 mmol/L)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (93)

Novartis Investigative Site

Benešov, Czech Republic, 25601, Czechia

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Novartis Investigative Site

Havířov, Czech Republic, 736 01, Czechia

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Novartis Investigative Site

Litomyšl, Czech Republic, 570 14, Czechia

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Novartis Investigative Site

Prague, Czech Republic, 140 00, Czechia

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Novartis Investigative Site

Prague, CZE, 128 08, Czechia

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Novartis Investigative Site

Broumov, 550 01, Czechia

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Novartis Investigative Site

Pardubice, 53002, Czechia

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Novartis Investigative Site

Copenhagen NV, DK-2400, Denmark

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Novartis Investigative Site

Copenhagen S, DK-2300, Denmark

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Novartis Investigative Site

Frederiksberg, DK-2000, Denmark

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Novartis Investigative Site

Hellerup, DK-2900, Denmark

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Novartis Investigative Site

Roskilde, DK-4000, Denmark

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Novartis Investigative Site

Slagelse, DK-4200, Denmark

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Novartis Investigative Site

Pärnu, 80018, Estonia

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Novartis Investigative Site

Tallinn, 10138, Estonia

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Novartis Investigative Site

Tallinn, 13415, Estonia

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Novartis Investigative Site

Tartu, 50410, Estonia

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Novartis Investigative Site

Alsdorf, 52477, Germany

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Novartis Investigative Site

Bad Oeynhausen, 32545, Germany

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Novartis Investigative Site

Dresden, 01307, Germany

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Novartis Investigative Site

Fulda, 36037, Germany

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Novartis Investigative Site

Kamp-Lintfort, 47475, Germany

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Novartis Investigative Site

Saarlouis, 66740, Germany

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Novartis Investigative Site

Senden, 48308, Germany

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Novartis Investigative Site

Alexandroupoli, GR 68100, Greece

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Novartis Investigative Site

Chios, 82100, Greece

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Novartis Investigative Site

Thessaloniki, 57001, Greece

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Novartis Investigative Site

Guatemala City, 01010, Guatemala

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Novartis Investigative Site

Guatemala City, 01011, Guatemala

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Novartis Investigative Site

Secunderabad, Andhra Pradesh, 500003, India

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Novartis Investigative Site

Visakhapatnam, Andhra Pradesh, 530002, India

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Novartis Investigative Site

Ahmedabad, Gujarat, 380014, India

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Novartis Investigative Site

Vadodara, Gujarat, 390015, India

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Novartis Investigative Site

Bangalore, Karnataka, 560078, India

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Novartis Investigative Site

Mangalore, Karnataka, 575002, India

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Novartis Investigative Site

Trivandrum, Kerala, 695011, India

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Novartis Investigative Site

Indore, Madhya Pradesh, 452010, India

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Novartis Investigative Site

Nagpur, Maharashtra, 440012, India

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Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, 110070, India

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Novartis Investigative Site

Ludhiana, Punjab, 141001, India

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Novartis Investigative Site

Jaipur, Rajasthan, 302001, India

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Novartis Investigative Site

Lucknow, Uttar Pradesh, 226003, India

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Novartis Investigative Site

Bergamo, BG, 24128, Italy

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Novartis Investigative Site

Florence, FI, 50143, Italy

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Novartis Investigative Site

Milan, MI, 20132, Italy

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Novartis Investigative Site

Passirana Di Rho, MI, 20017, Italy

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Novartis Investigative Site

Pavia, PV, 27100, Italy

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Novartis Investigative Site

Mercato San Severino, SA, 84085, Italy

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Novartis Investigative Site

Siena, SI, 53100, Italy

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Novartis Investigative Site

Novara, 28100, Italy

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Novartis Investigative Site

Daugavpils, LV-5401, Latvia

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Novartis Investigative Site

Preiļi, LV-5301, Latvia

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Novartis Investigative Site

Alytus, LT-62381, Lithuania

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Novartis Investigative Site

Kaunas, 50009, Lithuania

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Novartis Investigative Site

Vilnius, LT-05261, Lithuania

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Novartis Investigative Site

Vilnius, LT-08661, Lithuania

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Novartis Investigative Site

Gdansk, 80-847, Poland

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Novartis Investigative Site

Kłodzko, 57-300, Poland

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Novartis Investigative Site

Warsaw, 04-761, Poland

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Novartis Investigative Site

Wroclaw, 50-981, Poland

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Novartis Investigative Site

Bucharest, District 2, 021382, Romania

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Novartis Investigative Site

Craiova, Jud. Dolj, 200147, Romania

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Novartis Investigative Site

Baia Mare, Maramureş, 430071, Romania

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Novartis Investigative Site

Brasov, 500173, Romania

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Novartis Investigative Site

Kaliningrad, 236016, Russia

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Novartis Investigative Site

Kazan', 420012, Russia

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Novartis Investigative Site

Krasnodar, 350072, Russia

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Novartis Investigative Site

Moscow, 113093, Russia

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Novartis Investigative Site

Moscow, 117997, Russia

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Novartis Investigative Site

Moscow, 119048, Russia

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Novartis Investigative Site

Moscow, 121552, Russia

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Novartis Investigative Site

Moscow, 127473, Russia

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Novartis Investigative Site

Moscow, 129110, Russia

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Novartis Investigative Site

N.Novgorod, 603126, Russia

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Novartis Investigative Site

Nizhny Novgorod, 603018, Russia

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Novartis Investigative Site

Penza, 440026, Russia

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Novartis Investigative Site

Petrozavodsk, 185019, Russia

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Novartis Investigative Site

Saint Petersburg, 193312, Russia

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Novartis Investigative Site

Saint Petersburg, 197341, Russia

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Novartis Investigative Site

Saint Petersburg, 198013, Russia

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Novartis Investigative Site

Saint Petersburg, 199034, Russia

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Novartis Investigative Site

Samara, 443067, Russia

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Novartis Investigative Site

Saratov, 410012, Russia

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Novartis Investigative Site

Saratov, 410031, Russia

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Novartis Investigative Site

Singapore, 119074, Singapore

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Novartis Investigative Site

Singapore, 168752, Singapore

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Novartis Investigative Site

Dunajská Streda, Slovak Republic, 929 01, Slovakia

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Novartis Investigative Site

Nitra, Slovak Republic, 949 01, Slovakia

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Novartis Investigative Site

Banská Bystrica, 974 01, Slovakia

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Novartis Investigative Site

Komárno, 945 01, Slovakia

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Novartis Investigative Site

Košice, 040 01, Slovakia

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Novartis Investigative Site

Lučenec, 98439, Slovakia

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Novartis Investigative Site

Modava Nad Bodvou, 045 01, Slovakia

Location

Related Publications (1)

• 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.

  PMID: 29032139 DERIVED

Related Links

• Results for CLAF237A23118 from the Novartis Clinical Trials website

MeSH Terms

Conditions

Heart Failure; Diabetes Mellitus, Type 2; Metabolic Diseases; Cardiovascular Diseases

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Heart Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2009
• First Posted: May 7, 2009
• Study Start: May 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 17, 2020

Record last verified: 2014-04

Locations

GU (2); GR (3); IT (8); IN (13); ES (4); SG (2); CZ (7); LA (2); RO (4); LI (4); DK (6); PL (4); DE (7); SL (7); RU (20)