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

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ClinicalTrials.gov Identifier: NCT00894868
Recruitment Status : Completed
First Posted : May 7, 2009
Last Update Posted : May 13, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Type II Diabetes Mellitus Drug: vildagliptin Drug: placebo of vildagliptin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 798 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : May 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Vildagliptin Drug: vildagliptin
Placebo Comparator: Placebo Drug: placebo of vildagliptin



Primary Outcome Measures :
  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). [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894868


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Locations
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Czech Republic
Novartis Investigative Site
Praha 2, CZE, Czech Republic, 128 08
Novartis Investigative Site
Benesov, Czech Republic, 25601
Novartis Investigative Site
Broumov, Czech Republic, 550 01
Novartis Investigative Site
Havirov, Czech Republic, 736 01
Novartis Investigative Site
Litomysl, Czech Republic, 570 14
Novartis Investigative Site
Pardubice, Czech Republic, 53002
Novartis Investigative Site
Praha 4, Czech Republic, 140 00
Denmark
Novartis Investigative Site
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
Estonia
Novartis Investigative Site
Pärnu, Estonia, 80018
Novartis Investigative Site
Tallinn, Estonia, 10138
Novartis Investigative Site
Tallinn, Estonia, 13415
Novartis Investigative Site
Tartu, Estonia, 50410
Germany
Novartis Investigative Site
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
Greece
Novartis Investigative Site
Alexandroupolis, Greece, GR 68100
Novartis Investigative Site
Chios, Greece, 82100
Novartis Investigative Site
Thessaloniki, Greece, 57001
Guatemala
Novartis Investigative Site
Guatemala City, Guatemala, 01010
Novartis Investigative Site
Guatemala City, Guatemala, 01011
India
Novartis Investigative Site
Secunderabad, Andhra Pradesh, India, 500003
Novartis Investigative Site
Visakhapatnam, Andhra Pradesh, India, 530002
Novartis Investigative Site
Vishakhapatnam, Andhra Pradesh, India, 530002
Novartis Investigative Site
New Delhi, Delhi, India, 110070
Novartis Investigative Site
Ahmedabad, Gujarat, India, 380014
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Vadodara, Gujrat, India, 390015
Novartis Investigative Site
Bangalore, Karnataka, India, 560078
Novartis Investigative Site
Mangalore, Karnataka, India, 575002
Novartis Investigative Site
Trivandrum, Kerala, India, 695011
Novartis Investigative Site
Indore, Madhya Pradesh, India, 452010
Novartis Investigative Site
Nagpur, Maharashtra, India, 440012
Novartis Investigative Site
Ludhiana, Punjab, India, 141001
Novartis Investigative Site
Jaipur, Rajasthan, India, 302001
Novartis Investigative Site
Lucknow, Uttar Pradesh, India, 226003
Italy
Novartis Investigative Site
Bergamo, BG, Italy, 24128
Novartis Investigative Site
Firenze, FI, Italy, 50143
Novartis Investigative Site
Milano, MI, Italy, 20132
Novartis Investigative Site
Passirana di Rho, MI, Italy, 20017
Novartis Investigative Site
Pavia, PV, Italy, 27100
Novartis Investigative Site
Mercato San Severino, SA, Italy, 84085
Novartis Investigative Site
Siena, SI, Italy, 53100
Novartis Investigative Site
Novara, Italy, 28100
Latvia
Novartis Investigative Site
Daugavpils, Latvia, LV-5401
Novartis Investigative Site
Preili, Latvia, LV-5301
Lithuania
Novartis Investigative Site
Alytus, Lithuania, LT-62381
Novartis Investigative Site
Kaunas, Lithuania, 50009
Novartis Investigative Site
Vilnius, Lithuania, LT-05261
Novartis Investigative Site
Vilnius, Lithuania, LT-08661
Poland
Novartis Investigative Site
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
Romania
Novartis Investigative Site
Bucharest, District 2, Romania, 021382
Novartis Investigative Site
Craiova, Jud. Dolj, Romania, 200147
Novartis Investigative Site
Baia-Mare, Maramures, Romania, 430071
Novartis Investigative Site
Brasov, Romania, 500173
Russian Federation
Novartis Investigative Site
Moscow, Russia, Russian Federation, 117997
Novartis Investigative Site
Kaliningrad, Russian Federation, 236016
Novartis Investigative Site
Kazan, Russian Federation, 420012
Novartis Investigative Site
Krasnodar, Russian Federation, 350072
Novartis Investigative Site
Moscow, Russian Federation, 113093
Novartis Investigative Site
Moscow, Russian Federation, 119048
Novartis Investigative Site
Moscow, Russian Federation, 121552
Novartis Investigative Site
Moscow, Russian Federation, 127473
Novartis Investigative Site
Moscow, Russian Federation, 129110
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, 193312
Novartis Investigative Site
Saint-Petersburg, Russian Federation, 197341
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
Singapore
Novartis Investigative Site
Singapore, Singapore, 119074
Novartis Investigative Site
Singapore, Singapore, 168752
Slovakia
Novartis Investigative Site
Dunajska Streda, Slovak Republic, Slovakia, 929 01
Novartis Investigative Site
Nitra, Slovak Republic, Slovakia, 949 01
Novartis Investigative Site
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
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00894868     History of Changes
Other Study ID Numbers: CLAF237A23118
2008-005012-41 ( EudraCT Number )
First Posted: May 7, 2009    Key Record Dates
Last Update Posted: May 13, 2014
Last Verified: April 2014
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Congestive Heart Failure
CHF, vildagliptin
metabolic disease
cardiovascular disease
T2DM
Additional relevant MeSH terms:
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Heart Failure
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Vildagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action