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The study was terminated due to the unavailability of Continuous Glucose Monitoring sensors (CGMS) which were required to assess the primary end-point.
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Compare the effect of Vildagliptin plus Metformin versus Glimepiride plus Metformin on glucose variability in T2DM patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Vildagliptin plus metformin | Experimental | Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily). |
|
| Group B: Glimepiride plus metformin | Active Comparator | Participants received Glimepiride 1-6 mg once daily as an add-on to metformin (1000-1500mg daily). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug | Vildagliptin 50 mg twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Amplitude of Glycemic Excursions (MAGE) | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Age > 75 years ; BMI <22 or >40 kg/m2
Patients who are on Insulin therapy at the time of study entry.
Type 1 Diabetes Mellitus patients.
Patients with severe renal (creatinine clearance < 50 ml/min) or hepatic impairment (including pre-treatment ALT or AST > 3 x ULN).
Creatinine clearance will be estimated from serum creatinine using Cockcroft-Gault formula (Cockcroft and Gault, 1976)
Patients with contraindications as mentioned in the Summary of Product Characteristics (SPCs) for vildagliptin, metformin, glimepiride, vildagliptin plus metformin and glimiperide plus metformin.
Other protocol defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Vildagliptin Plus Metformin | Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily). |
| FG001 | Group B: Glimepiride Plus Metformin | Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: Vildagliptin Plus Metformin | Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily). |
| BG001 | Group B: Glimepiride Plus 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 | Mean Amplitude of Glycemic Excursions (MAGE) | The study was prematurely terminated due to the unavailability of CGMS required for the assessment of the primary end point. The non-availability of CGMS severely affected participant recruitment. The primary outcome was not analyzed. | Posted | 16 weeks |
|
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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 | Group A: Vildagliptin Plus Metformin | Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis | 862-778-8200 |
| 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 |
| C057619 | glimepiride |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Glimepiride |
| Drug |
Glimepiride 1-6 mg once daily |
|
| Metformin | Drug | Metformin (1000-1500 mg daily) |
|
| Withdrawal by Subject |
|
| Non-compliance |
|
| Adverse Event |
|
| Physician Decision |
|
Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| 0 |
| 48 |
| 4 |
| 48 |
| EG001 | Group B: Glimepiride Plus Metformin | Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily). | 1 | 47 | 1 | 47 |
| RESTLESSNESS | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| HYPERHIDROSIS | 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.
| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |