Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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2 October 2012 |
Main ID: |
EUCTR2008-005012-41-LT |
Date of registration:
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26/03/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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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Scientific title:
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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. |
Date of first enrolment:
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22/06/2009 |
Target sample size:
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246 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005012-41 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Countries of recruitment
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Czech Republic
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Denmark
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Estonia
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Germany
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Greece
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Guatemala
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India
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Italy
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Latvia
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Lithuania
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Poland
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Romania
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Russian Federation
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Slovakia
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Contacts
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Name:
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Clinical Trial Desk
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Address:
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Konstitucijos av.7
LT-09308
Vilnius
Lithuania |
Telephone:
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+3705269 1650 |
Email:
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DRA.Lithuania@novartis.com |
Affiliation:
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Novartis Pharma Services Inc. representative office in Lithuania |
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Name:
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Clinical Trial Desk
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Address:
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Konstitucijos av.7
LT-09308
Vilnius
Lithuania |
Telephone:
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+3705269 1650 |
Email:
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DRA.Lithuania@novartis.com |
Affiliation:
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Novartis Pharma Services Inc. representative office in Lithuania |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients must give written informed consent before any assessment is performed.
2. Patients 18-85 years old (inclusive) at Visit 1.
3. Patients with T2DM, diagnosed at least 3 months prior to Visit 1, either untreated (defined as not taking anti-diabetic therapy for at least 8 weeks prior to Visit 1) or treated with anti-diabetic therapy (defined as metformin, sulfonylurea, insulin, alpha-glucosidase inhibitors, or glinides as monotherapy or combination therapy for at least 8 weeks prior to Visit 1) and maintaining dietary advice and exercise habits during the full course of the study.
4. Stable dose of anti-diabetic therapy over the past 4 weeks prior to Visit 1 (stable insulin therapy is defined as ± 20% of total daily units) for patients on anti-diabetic treatment.
5. CHF (NYHA Class I, Class II, or Class III) at Visit 1.
• Treatment of heart failure should be according to guidlines (ACC/AHA 2005) and (ESC/EASD2007) and dosage of beta-blockers, angiotensin converting enzyme-inhibitors(ACE Is) or angiotensin receptor blockers (ARBs) should have been stable for one month prior to Visit 1.
6. LVEF < 40% (results must be available at Visit 2, prior to randomization)
7. HbA1c in the range of = 6.5% to 10% at Visit 1.
8. Body Mass Index (BMI) in the range of 22-42 kg/m2, inclusive, at Visit 1.
For detailed inclusion criteria, please refer to the full protocol. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 246 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 106
Exclusion criteria: 1. Fasting Plasma Glucose (FPG) = 270 mg/dL (15 mmol/L) at Visit 1.
2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
3. A history of:
• type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing’s syndrome and acromegaly.
• acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
4. Patients that have been enrolled in a vildagliptin clinical trial or taken other DPP-4 inhibitor, GLP-1 mimetics (e.g. exenatide), GLP-1 analogues (e.g. liraglutide) studies within 6 months prior to visit 1.
5. Patients taking vildagliptin at any time.
6. Patients taking thiazolidinediones (TZDs). TZDs given up to 12 months prior to Visit 1 are allowed.
7. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1 and other concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study
8. Any of the following within the past 6 months:
• myocardial infarction (MI) (if the visit 1 ECG reveals patterns consistent with a MI and the date of the event cannot be determined, then the patient can enter the study at the discretion of the investigator and the sponsor);
• coronary artery bypass surgery or percutaneous coronary intervention
• unstable angina
• stroke
9. Any of the following ECG abnormalities:
• Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation
• second degree AV block (Mobitz 1 and 2); patients with pacemakers are not excluded.
• third degree AV block; patients with pacemakers are not excluded.
• prolonged QTc (> 500 ms)
10. GFR (estimated by Cockcroft-Gault formula) < 30 mL/min at Visit 1.
For detailed exclusion criteria, please refer to the full protocol.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes. Heart failure (NYHA class I-III). MedDRA version: 14.0
Level: PT
Classification code 10067585
Term: Type 2 diabetes mellitus
System Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 14.0
Level: LLT
Classification code 10064081
Term: Heart failure NYHA class III
System Organ Class: 10007541 - Cardiac disorders
MedDRA version: 14.0
Level: LLT
Classification code 10064079
Term: Heart failure NYHA class I
System Organ Class: 10007541 - Cardiac disorders
MedDRA version: 14.0
Level: LLT
Classification code 10064080
Term: Heart failure NYHA class II
System Organ Class: 10007541 - Cardiac disorders
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Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
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Intervention(s)
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Trade Name: Galvus Product Name: vildagliptin Product Code: LAF237A Pharmaceutical Form: Tablet INN or Proposed INN: vildagliptin CAS Number: 274901-16-5 Current Sponsor code: LAF237A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: • 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) after 52 weeks of treatment.
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Primary end point(s): 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) after 52 weeks of treatment.
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Secondary Objective: • To evaluate the overall safety and tolerability of vildagliptin versus placebo in patients with T2DM and CHF (NYHA class I – III) over 52 weeks of treatment with special regards to signs and symptoms of heart failure. • 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.
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Timepoint(s) of evaluation of this end point: 52 weeks.
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Secondary Outcome(s)
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Secondary end point(s): 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.
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.
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Timepoint(s) of evaluation of this end point: 52 weeks.
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Secondary ID(s)
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2008-005012-41-CZ
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CLAF237A23118
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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