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This study will assess the efficacy of vildagliptin plus metformin (SPC) treatment in type 2 diabetes mellitus patients uncontrolled by metformin monotherapy after 24 weeks treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin plus metformin (SPC) | Experimental | Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug | Vildagliptin 50 mg plus metformin 500 mg as Single Pill combination (SPC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | HbA1c analysis will be performed on a blood sample obtained by study personnel. | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | HbA1c analysis will be performed on a blood sample obtained by study personnel. | Baseline, week 12 |
| Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24 |
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Inclusion criteria
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 | Changhua | 500 | Taiwan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vildagliptin Plus Metformin (SPC) | Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics used the Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement
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| ID | Title | Description |
|---|---|---|
| BG000 | Vildagliptin Plus Metformin (SPC) | Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24. |
| 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 | Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | HbA1c analysis will be performed on a blood sample obtained by study personnel. | Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement | Posted | Mean | Standard Deviation | percentage | Baseline, Week 24 |
|
|
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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 | Vildagliptin Plus Metformin (SPC) | Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pelvic cyst | Reproductive system and breast disorders | 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic 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 |
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FPG analysis will be performed on a blood sample obtained by study personnel.
| Baseline, week 12, week 24 |
| Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24 | PPG analysis will be performed on a blood sample obtained by study personnel. | Baseline, week, week 24 |
| Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week | Mean amplitude of glycemic excursions (MAGE), which was used to quantify major swings of glycaemia and assess intra-day glycemic variability, was measured by inserting continuous glucose monitoring system (CGMS) in patients for 72 consecutive hours before Day 1 (Visit 2) and Week 24 (Visit 5). In order to unify the different initial time and time of completion in each patient, only the data recorded from Day 2 00:00 to Day 3 23:59 with total 48 hours were analyzed. | Baseline, week 24 |
| The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment | Patients reaching glycemic goal of HbA1c ≤ 6.5% and ≤ 7.0% at week 12 and 24 will be calculated respectively. | week 12, week 24 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | HbA1c analysis will be performed on a blood sample obtained by study personnel. | Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement | Posted | Mean | Standard Deviation | percentage | Baseline, week 12 |
|
|
|
| Secondary | Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24 | FPG analysis will be performed on a blood sample obtained by study personnel. | Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement | Posted | Mean | Standard Deviation | mg/dL | Baseline, week 12, week 24 |
|
|
|
| Secondary | Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24 | PPG analysis will be performed on a blood sample obtained by study personnel. | Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement | Posted | Mean | Standard Deviation | mg/dL | Baseline, week, week 24 |
|
|
|
| Secondary | Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week | Mean amplitude of glycemic excursions (MAGE), which was used to quantify major swings of glycaemia and assess intra-day glycemic variability, was measured by inserting continuous glucose monitoring system (CGMS) in patients for 72 consecutive hours before Day 1 (Visit 2) and Week 24 (Visit 5). In order to unify the different initial time and time of completion in each patient, only the data recorded from Day 2 00:00 to Day 3 23:59 with total 48 hours were analyzed. | Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement | Posted | Mean | Standard Deviation | mg/dL | Baseline, week 24 |
|
|
|
| Secondary | The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment | Patients reaching glycemic goal of HbA1c ≤ 6.5% and ≤ 7.0% at week 12 and 24 will be calculated respectively. | Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement | Posted | Number | percentage of participants | week 12, week 24 |
|
|
|
| 1 |
| 40 |
| 23 |
| 40 |
| Myocardial ischaemia | Cardiac disorders | 18.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | 18.1 | Systematic Assessment |
|
| Abdominal adhesions | Gastrointestinal disorders | 18.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | 18.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | 18.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | 18.1 | Systematic Assessment |
|
| Gastritis haemorrhagic | Gastrointestinal disorders | 18.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 18.1 | Systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | 18.1 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | 18.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | 18.1 | Systematic Assessment |
|
| Pyrexia | General disorders | 18.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | 18.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | 18.1 | Systematic Assessment |
|
| Hepatitis B | Infections and infestations | 18.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | 18.1 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | 18.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | 18.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | 18.1 | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | 18.1 | Systematic Assessment |
|
| Vulvovaginitis | Infections and infestations | 18.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | 18.1 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | 18.1 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | 18.1 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | 18.1 | Systematic Assessment |
|
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 18.1 | Systematic Assessment |
|
| Benign ovarian tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 18.1 | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | 18.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | 18.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | 18.1 | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | 18.1 | Systematic Assessment |
|
| Pelvic adhesions | Reproductive system and breast disorders | 18.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
|
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | 18.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | 18.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | 18.1 | 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.
| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| HbA1c ≤ 7.0% Week 24 |
|