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The purpose of this study was to observe change of HbA1c over time from baseline to month 12. The ultimate goal of this study was to provide a local reference value to the physicians & patients in the future when they consider initiating Vildagliptin and taking balance between efficacy, compliance, risk factors, convenience and medication cost.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAF237 (vildagliptin) 50mg once daily (QD) | Active Comparator | Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin |
|
| LAF237 (vildagliptin) 50mg twice daily (BID) | Active Comparator | Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAF237 (vildagliptin) | Drug | Vildagliptin 50mg capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 12 | HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c | Baseline, Month 12 (weeK 52) |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis) | HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c. Mixed Model of Repeated Measures (MMRM) was used to analyze this outcome. For the MMRM analysis, the model includes terms for treatment, period, treatment-by-period interaction and baseline value, and further adjusted by age, pre-existing hypertension and microvascular and macrovascular complications for diabetes mellitus. The variables selected for baseline adjustment were based on the lowest AIC. |
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Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Hong Kong | Hong Kong | Hong Kong | |||
| Novartis Investigative Site |
There was 117 patients randomized and received either Vildagliptin 50mg QD or 50 mg BID.
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| ID | Title | Description |
|---|---|---|
| FG000 | LAF237 (Vildagliptin) 50mg Once Daily (QD) | Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin |
| FG001 | LAF237 (Vildagliptin) 50mg Twice Daily (BID) | Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent to treat (ITT) included all randomized patients who received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | LAF237 (Vildagliptin) 50mg Once Daily (QD) | Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin |
| BG001 | LAF237 (Vildagliptin) 50mg Twice Daily (BID) | Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 12 | HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c | Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication. Patients with both baseline and 12 month data were included in this analysis | Posted | Mean | Standard Deviation | percentage of Glycosylated Hemoglobin | Baseline, Month 12 (weeK 52) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LAF237 (Vildagliptin) 50mg Once Daily (QD) | Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Duodenitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinea | Infections and infestations | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | trialandresults.registries@novartis.com |
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| ID | Term |
|---|---|
| C475520 | 1-(((3-hydroxy-1-adamantyl)amino)acetyl)-2-cyanopyrrolidine |
| D000077597 | Vildagliptin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Metformin | Drug | Metformin maximum tolerance dose |
|
| Baseline, Month 3, 6, 9 and 12 |
| Change in Fasting Plasma Glucose (FPG) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis) | Blood samples were collected to analyze fasting plasma glucose. Mixed Model of Repeated Measures (MMRM) was used to analyze this outcome. For the MMRM analysis, the model included terms for treatment, period, treatment-by-period interaction and baseline value, and further adjusted by pre-existing hypertension. The variable selected for baseline adjustment was based on the lowest AIC. | Baseline, Month 3, 6, 9 and 12 |
| Percentage of Patients Achieving Good Glycemic Control | Blood samples were collected to analyze HbA1c. Good glycemic control is defined as patient achieving Hb1Ac < 7.0%. Percentage of patients who achieved HbA1c less than 7.0% at month 3, 6, 9 and 12 were reported for this endpoint. | Month 3, 6, 9, 12 |
| Percentage of Overall Drug Compliance in 12 Months | The overall drug compliance (%) = (Observed Consumption / Expected Consumption) x 100% Where (Observed Consumption / Expected Consumption) = [1- (Number of missing tablets from all visits/(sum of Allocated Daily Dosage (in tablets) from all visits × No. of Days between the Date Dispensed and the Date Returned))] | Month 12 |
| Number of Patients With Adverse Events, Serious Adverse Events and Death as an Assessment of Overall Safety and Tolerability | This analysis reported percentage patients with adverse events and patient discontinued from the study due to adverse events. Aslo, percentage of patients with serious adverse events and death was reported. | Month 12 |
| Tuenmen |
| Hong Kong |
| Hong Kong |
| Novartis Investigative Site | Hong Kong | Hong Kong |
| Novartis Investigative Site | Hong Kong SAR | Hong Kong |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin |
|
|
| Secondary | Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis) | HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c. Mixed Model of Repeated Measures (MMRM) was used to analyze this outcome. For the MMRM analysis, the model includes terms for treatment, period, treatment-by-period interaction and baseline value, and further adjusted by age, pre-existing hypertension and microvascular and macrovascular complications for diabetes mellitus. The variables selected for baseline adjustment were based on the lowest AIC. | Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication. . | Posted | Least Squares Mean | Standard Error | percentage of Glycosylated Hemoglobin | Baseline, Month 3, 6, 9 and 12 |
|
|
|
| Secondary | Change in Fasting Plasma Glucose (FPG) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis) | Blood samples were collected to analyze fasting plasma glucose. Mixed Model of Repeated Measures (MMRM) was used to analyze this outcome. For the MMRM analysis, the model included terms for treatment, period, treatment-by-period interaction and baseline value, and further adjusted by pre-existing hypertension. The variable selected for baseline adjustment was based on the lowest AIC. | Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Month 3, 6, 9 and 12 |
|
|
|
| Secondary | Percentage of Patients Achieving Good Glycemic Control | Blood samples were collected to analyze HbA1c. Good glycemic control is defined as patient achieving Hb1Ac < 7.0%. Percentage of patients who achieved HbA1c less than 7.0% at month 3, 6, 9 and 12 were reported for this endpoint. | Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication. 'n' indicates patients with HbA1c data in that time point. | Posted | Number | Percentage of patients | Month 3, 6, 9, 12 |
|
|
|
| Secondary | Percentage of Overall Drug Compliance in 12 Months | The overall drug compliance (%) = (Observed Consumption / Expected Consumption) x 100% Where (Observed Consumption / Expected Consumption) = [1- (Number of missing tablets from all visits/(sum of Allocated Daily Dosage (in tablets) from all visits × No. of Days between the Date Dispensed and the Date Returned))] | Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication. Patients who had reported dosing compliance were included in this analysis. | Posted | Mean | Standard Deviation | Percentage of overall drug compliance | Month 12 |
|
|
|
| Secondary | Number of Patients With Adverse Events, Serious Adverse Events and Death as an Assessment of Overall Safety and Tolerability | This analysis reported percentage patients with adverse events and patient discontinued from the study due to adverse events. Aslo, percentage of patients with serious adverse events and death was reported. | Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication. | Posted | Number | Patients | Month 12 |
|
|
|
| 2 |
| 56 |
| 14 |
| 56 |
| EG001 | LAF237 (Vildagliptin) 50mg Twice Daily (BID) | Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin | 2 | 61 | 7 | 61 |
| Leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| stone impairation over proximal urethra | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Elevated liver function test | Investigations | MedDRA | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| D006571 |
| Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| 9 month from baseline |
|
| 12 month from baseline |
|
| 9 month from baseline |
|
| 12 month from baseline |
|
| At Month 6 |
|
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| At Month 9 |
|
|
| At Month 12 |
|
|
| Death |
|
| Patients discontinued due to any AE/SAE |
|