Efficacy and Safety of Vildagliptin as add-on Therapy to Metformin in Patients With Type 2 Diabetes
NCT ID: NCT01497522
Last Updated: 2017-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
183 participants
INTERVENTIONAL
2011-12-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vildagliptin
In addition to their stable dose of metformin monotherapy, patients should take vildagliptin 50 mg twice daily.
Vildagliptin
vildagliptin 50 mg twice daily
Placebo
In addition to their stable dose of metformin monotherapy, patients should take vildagliptin matching placebo.
Placebo
Matching Placebo of vildagliptin 50 mg twice daily
Interventions
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Vildagliptin
vildagliptin 50 mg twice daily
Placebo
Matching Placebo of vildagliptin 50 mg twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HbA1c in the range of 7.0-10.0%
* Body mass index in the range 20-35 kg/m2
Exclusion Criteria
* Significant heart diseases
20 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan
Novartis Investigative Site
Kurume, Fukuoka, Japan
Novartis Investigative Site
Ohkawa-city, Fukuoka, Japan
Novartis Investigative Site
Kawasaki, Kanagawa, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Kyoto, Kyoto, Japan
Novartis Investigative Site
Kyoto, Kyoto, Japan
Novartis Investigative Site
Takatsuki, Osaka, Japan
Novartis Investigative Site
Ageo, Saitama, Japan
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan
Novartis Investigative Site
Edogawa-ku, Tokyo, Japan
Novartis Investigative Site
Hachiōji, Tokyo, Japan
Novartis Investigative Site
Kiyose, Tokyo, Japan
Novartis Investigative Site
Minato-ku, Tokyo, Japan
Novartis Investigative Site
Minato-ku, Tokyo, Japan
Novartis Investigative Site
Nerima-ku, Tokyo, Japan
Novartis Investigative Site
Shinagawa-ku, Tokyo, Japan
Novartis Investigative Site
Toshima-ku, Tokyo, Japan
Countries
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References
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Odawara M, Hamada I, Suzuki M. Efficacy and Safety of Vildagliptin as Add-on to Metformin in Japanese Patients with Type 2 Diabetes Mellitus. Diabetes Ther. 2014 Jun;5(1):169-81. doi: 10.1007/s13300-014-0059-x. Epub 2014 Mar 7.
Other Identifiers
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CLMF237A1301
Identifier Type: -
Identifier Source: org_study_id
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