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The purpose of this study is to assess the efficacy and safety of vildagliptin 50mg bid add-on therapy to improve overall glycemic control in patients with type 2 diabetes mellitus inadequately controlled on insulin with or without metformin treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin | Experimental | Eligible patients will receive vildagliptin 50 mg in addition to their stable dose of insulin with or without metformin. One tablet should be taken twice daily as one tablet before breakfast meal and one tablet before the evening meal for 24 weeks. |
|
| Placebo | Placebo Comparator | Eligible patients will receive matching placebo in addition to their stable dose of insulin with or without metformin. One tablet should be taken twice daily as one tablet before breakfast meal and one tablet before the evening meal for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug | Patient will receive vildagliptin 50mg twice daily (bid) in addition to their stable dose of insulin with or without metformin for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in overall study population | HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive. | Baseline and every study visit up to 24 weeks |
| Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in Chinese study population | HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive. | Baseline and every study visit up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events, serious adverse events and death on over all population | Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. 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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Inclusion Criteria:
Exclusion Criteria:
Patients fulfilling any of the following criteria are not eligible for participation in the study
Other protocol defined inclusion/excusion 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 | Beijing | Beijing Municipality | 100730 | China | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25929739 | Derived | Ning G, Wang W, Li L, Ma J, Lv X, Yang M, Wang W, Woloschak M, Lukashevich V, Kothny W. Vildagliptin as add-on therapy to insulin improves glycemic control without increasing risk of hypoglycemia in Asian, predominantly Chinese, patients with type 2 diabetes mellitus. J Diabetes. 2016 May;8(3):345-53. doi: 10.1111/1753-0407.12303. |
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|
| Placebo | Drug | Patient will receive matching placebo to vildagliptin in addition to their stable dose of insulin with or without metformin for 24 weeks |
|
| 24 weeks |
| Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG)on overall population | FPG will be performed on the blood samples collected at all every study visits from baseline to week 24. | Baseline, week 24 |
| Percentage of patients meeting responder criteria after 24 weeks treatment on overall population | Responder rate will be analyzed in the following categories:
| After 24 weeks |
| Number of patients with adverse events, serious adverse events and death on Chinese population | Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. 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. | 24 weeks |
| Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG) on Chinese population | FPG will be performed on the blood samples collected at all every study visits from baseline to week 24. | Baseline, week 24 |
| Percentage of patients meeting responder criteria after 24 weeks treatment on Chinese population | Responder rate will be analyzed in the following categories: • Endpoint HbA1c ≤ 6.5% • Endpoint HbA1c < 7% • Endpoint HbA1c <7% in patients with baseline HbA1c ≤ 8% The percentage of patients meeting each of the responder criteria as described, as well as the percentage of patients meeting any of these criteria in each treatment group will be computed | After 24 weeks |
| Changsha |
| Hunan |
| 410003 |
| China |
| Novartis Investigative Site | Changsha | Hunan | 410011 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210006 | China |
| Novartis Investigative Site | Wuxi | Jiangsu | 214023 | China |
| Novartis Investigative Site | Nanchang | Jiangxi | 330006 | China |
| Novartis Investigative Site | Shenyang | Liaoning | 110003 | China |
| Novartis Investigative Site | Jinan | Shandong | 250031 | China |
| Novartis Investigative Site | Xi’an | Shanxi | 710032 | China |
| Novartis Investigative Site | Chengdu | Sichuan | 610072 | China |
| Novartis Investigative Site | Beijing | China |
| Novartis Investigative Site | Shanghai | 200025 | China |
| Novartis Investigative Site | Tianjin | 300052 | China |
| Novartis Investigative Site | Pasay | Philippines | 1300 | Philippines |
| Novartis Investigative Site | Metro Manila | 1500 | Philippines |
| Novartis Investigative Site | Quezon City | 1102 | Philippines |
| Novartis Investigative Site | Singapore | Singapore | 768825 | Singapore |
| Novartis Investigative Site | Singapore | 169608 | Singapore |
| Novartis Investigative Site | Bangkok | Bangkok | 10330 | Thailand |
| Novartis Investigative Site | Bangkok | 10400 | Thailand |
| Novartis Investigative Site | Khon Kaen | 40002 | Thailand |
| 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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