Study of Efficacy and Safety LMF237 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Vildagliptin Monotherapy
NCT ID: NCT01811485
Last Updated: 2015-02-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
171 participants
INTERVENTIONAL
2013-05-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LMF237 50/250 mg
Patients took LMF237 50/250 mg twice daily for 14 weeks
LMF237 50/250 mg
Corresponds to vildagliptin 50 mg twice daily and metformin 250 mg twice daily
LMF237 50/500 mg
Corresponds to vildagliptin 50 mg twice daily and metformin 500 mg twice daily
LMF237 50/500 mg
Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
LMF237 50/250 mg
Corresponds to vildagliptin 50 mg twice daily and metformin 250 mg twice daily
Placebo
Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
Placebo
Matching placebo of LMF237 (contained vildagliptin 50 mg as active ingredient) twice daily
Interventions
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LMF237 50/250 mg
Corresponds to vildagliptin 50 mg twice daily and metformin 250 mg twice daily
LMF237 50/500 mg
Corresponds to vildagliptin 50 mg twice daily and metformin 500 mg twice daily
Placebo
Matching placebo of LMF237 (contained vildagliptin 50 mg as active ingredient) twice daily
Eligibility Criteria
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Inclusion Criteria
* HbA1c in the range of 7.0-10.0%
* Body mass index in the range of 20-35 kg/m\^2
Exclusion Criteria
20 Years
74 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
Chikushino-shi, Fukuoka, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Iizuka, Fukuoka, Japan
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan
Novartis Investigative Site
Koga, Ibaraki, Japan
Novartis Investigative Site
Kawasaki, Kanagawa, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Yatsushiro, Kumamoto, Japan
Novartis Investigative Site
Yatsushiro, Kumamoto, Japan
Novartis Investigative Site
Kyoto, Kyoto, Japan
Novartis Investigative Site
Kyoto, Kyoto, Japan
Novartis Investigative Site
Sakai, Osaka, Japan
Novartis Investigative Site
Takatsuki, Osaka, Japan
Novartis Investigative Site
Ageo, Saitama, Japan
Novartis Investigative Site
Tokorozawa, 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
Hachiōji, Tokyo, Japan
Novartis Investigative Site
Katsushika-ku, 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
Shibuya-ku, Tokyo, Japan
Novartis Investigative Site
Shinagawa-ku, Tokyo, Japan
Novartis Investigative Site
Toshima-ku, Tokyo, Japan
Countries
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Other Identifiers
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CLMF237A1303
Identifier Type: -
Identifier Source: org_study_id
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