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


Tracking Information

Start Date  ICMJEMay 2009
Estimated Primary Completion DateMay 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: May 6, 2009)		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 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00894868 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: May 6, 2009)
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEEffect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure
Official Title  ICMJEA 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
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.

Detailed Description 
Study PhasePhase IV
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Condition  ICMJE
  • Congestive Heart Failure
  • Type II Diabetes Mellitus
Intervention  ICMJE
  • Drug: vildagliptin
  • Drug: placebo of vildagliptin
Study Arms / Comparison Groups
  • Vildagliptin: Experimental
    Intervention: Drug: vildagliptin
  • Placebo: Placebo Comparator
    Intervention: Drug: placebo of vildagliptin

Recruitment Information

Estimated Enrollment  ICMJE490
Completion Date 
Estimated Primary Completion DateMay 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
GenderBoth
Ages18 Years to 85 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Novartis Pharma AG+41 61 32 4111
Location Countries  ICMJECzech Republic,   Estonia,   India,   Italy,   Latvia,   Lithuania,   Poland,   Romania,   Russian Federation,   Slovakia

Administrative Information

NCT ID  ICMJENCT00894868
Responsible PartyExternal Affairs, Novartis Pharma AG
Study ID Numbers  ICMJECLAF237A23118, EUDRACT number:2008-005012-41
Study Sponsor  ICMJENovartis Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE 
Information Provided ByNovartis