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Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00106340
Collaborator
(none)
3,118
Enrollment
2
Locations
2
Arms
38.6
Duration (Months)
1559
Patients Per Site
40.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the long term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
3118 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes
Study Start Date :
Mar 1, 2005
Actual Primary Completion Date :
May 1, 2008
Actual Study Completion Date :
May 20, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vildagliptin

Drug: vildagliptin
Other Names:
  • LAF237, Galvus

    • Drug: Metformin

    Drug: Glimepiride matching placebo
    Active Comparator: Glimepiride

    Drug: glimepiride

    Drug: Metformin

    Drug: Vildagliptin matching placebo

    Outcome Measures

    Primary Outcome Measures

    1. Time to HbA1c >8% [2 year]

    Secondary Outcome Measures

    1. Change from baseline in HbA1c at 5 years [2 years (amended)]

    2. Adverse event profile after 5 years of treatment [2 years (amended)]

    3. Coefficient of failure for HbA1c from week 24 to 5 years [2 years (amended)]

    4. Change from baseline in fasting plasma glucose at 5 years [2 years (amended)]

    5. Change from baseline in body weight at 5 years [2 years (amended)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 73 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • On a stable dose of metformin as defined by the protocol

    • Body mass index (BMI) in the range 22-45

    • Blood glucose criteria must be met

    Exclusion Criteria:

    • Pregnancy or lactation

    • Type 1 diabetes

    • Evidence of significant diabetic complications

    • Evidence of serious cardiovascular complications

    • Laboratory value abnormalities as defined by the protocol

    • Other protocol-defined exclusion criteria may apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Pharmaceuticals East Hanover New Jersey United States 07936
    2 Investigative Centers Nurnberg Germany

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00106340
    Other Study ID Numbers:
    • CLAF237A2308
    First Posted:
    Mar 23, 2005
    Last Update Posted:
    Dec 17, 2020
    Last Verified:
    Dec 1, 2012
    Keywords provided by , ,
    type 2 diabetes
    vildagliptin
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Metformin
    Glimepiride
    Vildagliptin

    Study Results

    No Results Posted as of Dec 17, 2020