- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01497522
Efficacy and Safety of Vildagliptin as add-on Therapy to Metformin in Patients With Type 2 Diabetes
February 23, 2017 updated by: Novartis Pharmaceuticals
A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 12 Weeks Treatment With LAF237 50 mg Bid to Placebo as Add-On Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy
The purpose of the study is to evaluate the efficacy and safety of vildagliptin 50 mg bid as an add-on therapy to metformin in Japanese patients with T2DM.
This study is being conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of Type 2 diabetes mellitus (T2DM) in Japan.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
183
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fukuoka, Japan, 819-0168
- Novartis Investigative Site
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Fukuoka, Japan, 810-0001
- Novartis Investigative Site
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Kyoto, Japan, 607-8062
- Novartis Investigative Site
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Fukuoka
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Kitakyushu, Fukuoka, Japan, 800-0296
- Novartis Investigative Site
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Kurume, Fukuoka, Japan, 830-8543
- Novartis Investigative Site
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Ohkawa-city, Fukuoka, Japan, 831-0016
- Novartis Investigative Site
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Kanagawa
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Kawasaki-city, Kanagawa, Japan, 210-0014
- Novartis Investigative Site
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Yokohama, Kanagawa, Japan, 221-0802
- Novartis Investigative Site
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Kyoto
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Kyoto-city, Kyoto, Japan, 615-0035
- Novartis Investigative Site
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Osaka
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Takatsuki, Osaka, Japan, 569-1096
- Novartis Investigative Site
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Saitama
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Ageo-city, Saitama, Japan, 362-8588
- Novartis Investigative Site
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-0031
- Novartis Investigative Site
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Edogawa-ku, Tokyo, Japan, 134-0084
- Novartis Investigative Site
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Hachioji, Tokyo, Japan, 192-0046
- Novartis Investigative Site
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Kiyose, Tokyo, Japan, 204-0021
- Novartis Investigative Site
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Minato-ku, Tokyo, Japan, 105-7390
- Novartis Investigative Site
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Minato-ku, Tokyo, Japan, 108-0075
- Novartis Investigative Site
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Nerima-ku, Tokyo, Japan, 177-0051
- Novartis Investigative Site
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Shinagawa-ku, Tokyo, Japan, 141-0032
- Novartis Investigative Site
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Toshima-ku, Tokyo, Japan, 171-0021
- Novartis Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy.
- HbA1c in the range of 7.0-10.0%
- Body mass index in the range 20-35 kg/m2
Exclusion Criteria:
- Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- Significant heart diseases
Other protocol-defined inclusion/exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vildagliptin
In addition to their stable dose of metformin monotherapy, patients should take vildagliptin 50 mg twice daily.
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vildagliptin 50 mg twice daily
Other Names:
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Placebo Comparator: Placebo
In addition to their stable dose of metformin monotherapy, patients should take vildagliptin matching placebo.
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Matching Placebo of vildagliptin 50 mg twice daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in glycosylated hemoglobin (HbA1c) at 12 weeks between treatment groups
Time Frame: Baseline to 12 weeks
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HbA1c will be performed on a blood sample obtained by study personnel and measured by high-performance liquid chromatography (HPLC) performed at a central laboratory.
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Baseline to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in HbA1c at 12 weeks within subgroups of metformin doses
Time Frame: Baseline to 12 weeks
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HbA1c will be performed on a blood sample obtained by study personnel and measured by high-performance liquid chromatography (HPLC) performed at a central laboratory.
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Baseline to 12 weeks
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Change from baseline in Fasting plasma glucose (FPG) at 12 weeks
Time Frame: Baseline to 12 weeks
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FPG will be performed on a blood sample obtained by study personnel and analyzed at a central laboratory.
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Baseline to 12 weeks
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Percentage of patients meeting Responder rates in HbA1c
Time Frame: 12 weeks
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Responder rates will be categorized by predefined HbA1c value at 12 weeks :
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12 weeks
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Number of patients with adverse events (including hypoglycemia), serious adverse events and death
Time Frame: 12 weeks
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The occurrence of adverse events will be sought by non-directive questioning of the patient at each visit.
Adverse events are defined as appearance or worsening of any undesirable symptom, sign (including an abnormal laboratory finding), or medical conditions.
Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
December 20, 2011
First Submitted That Met QC Criteria
December 20, 2011
First Posted (Estimate)
December 22, 2011
Study Record Updates
Last Update Posted (Actual)
February 27, 2017
Last Update Submitted That Met QC Criteria
February 23, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Dipeptidyl-Peptidase IV Inhibitors
- Vildagliptin
Other Study ID Numbers
- CLMF237A1301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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