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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin | Experimental | In addition to their stable dose of metformin monotherapy, patients should take vildagliptin 50 mg twice daily. |
|
| Placebo | Placebo Comparator | In addition to their stable dose of metformin monotherapy, patients should take vildagliptin matching placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug | vildagliptin 50 mg twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in glycosylated hemoglobin (HbA1c) at 12 weeks between treatment groups | 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. | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c at 12 weeks within subgroups of metformin doses | 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. | Baseline to 12 weeks |
| Change from baseline in Fasting plasma glucose (FPG) at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Fukuoka | Fukuoka | 810-0001 | Japan | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24604395 | Result | 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. |
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| Placebo | Drug | Matching Placebo of vildagliptin 50 mg twice daily |
|
FPG will be performed on a blood sample obtained by study personnel and analyzed at a central laboratory. |
| Baseline to 12 weeks |
| Percentage of patients meeting Responder rates in HbA1c | Responder rates will be categorized by predefined HbA1c value at 12 weeks :
| 12 weeks |
| Number of patients with adverse events (including hypoglycemia), serious adverse events and death | 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. | 12 weeks |
| Fukuoka |
| Fukuoka |
| 819-0168 |
| Japan |
| Novartis Investigative Site | Kitakyushu | Fukuoka | 800-0296 | Japan |
| Novartis Investigative Site | Kurume | Fukuoka | 830-8543 | Japan |
| Novartis Investigative Site | Ohkawa-city | Fukuoka | 831-0016 | Japan |
| Novartis Investigative Site | Kawasaki | Kanagawa | 210-0014 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 221-0802 | Japan |
| Novartis Investigative Site | Kyoto | Kyoto | 607-8062 | Japan |
| Novartis Investigative Site | Kyoto | Kyoto | 615-0035 | Japan |
| Novartis Investigative Site | Takatsuki | Osaka | 569-1096 | Japan |
| Novartis Investigative Site | Ageo | Saitama | 362-8588 | Japan |
| Novartis Investigative Site | Bunkyo-ku | Tokyo | 113-0031 | Japan |
| Novartis Investigative Site | Edogawa-ku | Tokyo | 134-0084 | Japan |
| Novartis Investigative Site | Hachiōji | Tokyo | 192-0046 | Japan |
| Novartis Investigative Site | Kiyose | Tokyo | 204-0021 | Japan |
| Novartis Investigative Site | Minato-ku | Tokyo | 105-7390 | Japan |
| Novartis Investigative Site | Minato-ku | Tokyo | 108-0075 | Japan |
| Novartis Investigative Site | Nerima-ku | Tokyo | 177-0051 | Japan |
| Novartis Investigative Site | Shinagawa-ku | Tokyo | 141-0032 | Japan |
| Novartis Investigative Site | Toshima-ku | Tokyo | 171-0021 | Japan |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| C475520 | 1-(((3-hydroxy-1-adamantyl)amino)acetyl)-2-cyanopyrrolidine |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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