Study of Efficacy and Safety of Vildagliptin as add-on Insulin Therapy in T2DM Patients
NCT ID: NCT02002221
Last Updated: 2016-03-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
156 participants
INTERVENTIONAL
2013-12-31
2015-02-28
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
TRIPLE
Study Groups
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Vildagliptin (LAF237)
Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
Vildagliptin (LAF237)
Corresponds to vildagliptin (LAF237) 50 mg tablets twice daily
Insulin
Patients continued their prescribed insulin dose. The dose of insulin remained within a 10% increase of the baseline dose throughout the trial (with no change in frequency or insulin type) unless dose adjustments were required for safety reasons.
The insulin dose was allowed to be decreased for safety reasons at anytime without specific dose limits at the Investigator's discretion.
Metformin
Patients continued their prescribed metformin dose, if applicable.
Placebo
In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
Placebo
Matching placebo of vildagliptin 50 mg twice daily
Insulin
Patients continued their prescribed insulin dose. The dose of insulin remained within a 10% increase of the baseline dose throughout the trial (with no change in frequency or insulin type) unless dose adjustments were required for safety reasons.
The insulin dose was allowed to be decreased for safety reasons at anytime without specific dose limits at the Investigator's discretion.
Metformin
Patients continued their prescribed metformin dose, if applicable.
Interventions
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Vildagliptin (LAF237)
Corresponds to vildagliptin (LAF237) 50 mg tablets twice daily
Placebo
Matching placebo of vildagliptin 50 mg twice daily
Insulin
Patients continued their prescribed insulin dose. The dose of insulin remained within a 10% increase of the baseline dose throughout the trial (with no change in frequency or insulin type) unless dose adjustments were required for safety reasons.
The insulin dose was allowed to be decreased for safety reasons at anytime without specific dose limits at the Investigator's discretion.
Metformin
Patients continued their prescribed metformin dose, if applicable.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HbA1c ≥ 7.0 to ≤ 10% at Visit 1.
* Age: ≥ 20 to \< 75 years old at Visit 1.
* BMI ≥ 20 to ≤ 35 kg/m2 at Visit 1.
Exclusion Criteria
* Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.
* Significant heart diseases
* Hepatic disorder
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
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Fukutsu, Fukuoka, Japan
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan
Novartis Investigative Site
Kōriyama, Fukushima, Japan
Novartis Investigative Site
Mito, Ibaraki, Japan
Novartis Investigative Site
Ibusuki, Kagoshima-ken, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Kumamoto, Kumamoto, Japan
Novartis Investigative Site
Kumamoto, Kumamoto, Japan
Novartis Investigative Site
Yatsushiro, Kumamoto, Japan
Novartis Investigative Site
Kyoto, Kyoto, Japan
Novartis Investigative Site
Sendai, Miyagi, Japan
Novartis Investigative Site
Hirakata, Osaka, Japan
Novartis Investigative Site
Izumisano, Osaka, Japan
Novartis Investigative Site
Osaka, Osaka, Japan
Novartis Investigative Site
Osaka, Osaka, Japan
Novartis Investigative Site
Takatsuki, Osaka, Japan
Novartis Investigative Site
Ageo, Saitama, Japan
Novartis Investigative Site
Saitama, Saitama, Japan
Novartis Investigative Site
Sayama, Saitama, Japan
Novartis Investigative Site
Tokorozawa, Saitama, Japan
Novartis Investigative Site
Adachi-ku, Tokyo, Japan
Novartis Investigative Site
Chiyoda-ku, Tokyo, Japan
Novartis Investigative Site
Chuo-ku, Tokyo, Japan
Novartis Investigative Site
Chuo-ku, Tokyo, Japan
Novartis Investigative Site
Chuo-ku, Tokyo, Japan
Novartis Investigative Site
Nerima-ku, Tokyo, Japan
Novartis Investigative Site
Nerima-ku, Tokyo, Japan
Novartis Investigative Site
Ōta-ku, Tokyo, Japan
Novartis Investigative Site
Suginami-ku, Tokyo, Japan
Countries
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References
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Hirose T, Suzuki M, Tsumiyama I. Efficacy and Safety of Vildagliptin as an Add-on to Insulin with or without Metformin in Japanese Patients with Type 2 Diabetes Mellitus: A 12-week, Double-Blind, Randomized Study. Diabetes Ther. 2015 Dec;6(4):559-571. doi: 10.1007/s13300-015-0147-6. Epub 2015 Nov 30.
Other Identifiers
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CLAF237A1405
Identifier Type: -
Identifier Source: org_study_id
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