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To compare a therapeutic strategy combining vildagliptin+metformin + Basal Insulin versus SU+metformin + Basal Insulin on the incidence of hypoglycemic events over 24 weeks.
This study, conducted in T2DM patients failing a dual therapy with metformin/SU in whom the decision to start basal insulin has been taken, will compare vildagliptin+metformin versus the previously used SU+met combination (regimen kept unchanged) in association with basal insulin, up-titrated as per usual algorithms primarily based on FPG to obtain a similar improvement in glycemic control in both arms, on the incidence of hypoglycemic episodes over 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SU+metformin + Basal Insulin | Active Comparator | Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG |
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| Metformin/vildagliptin + Basal Insulin | Experimental | Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug | 50 mg b.i.d |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Reported at Least One Symptomatic Hypoglycemic Event During the 24 Week Randomized Period in Both Treatment Arms | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Reaching Their Glycemic Target Without Hypoglycemic Events | Glycemic target is defined as Glycated hemoglobin(HbA1c) ≤ 7% | 24 weeks |
| Change From Baseline in HbA1c to Week 24 in Both Treatment Arms |
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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 | Antibes | 06600 | France | |||
| Novartis Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metformin/Vildagliptin + Basal Insulin | Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG |
| FG001 | SU+Metformin + Basal Insulin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Metformin | Drug | metformin is to be kept unchanged |
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| sulfonylurea (SU) | Drug |
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| Basal Insulin | Drug |
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| Baseline, Week 24 |
| Change From Baseline in Body Weight in Both Treatment Arms | Baseline, Week 24 |
| Mean Daily Insulin Dose at Week 24 | Week 24 |
| Percentage of Patients With Severe and Confirmed Hypoglycemic Events | Severe hypoglycemic events (and number of events) , defined as events requiring assistance of a third party, and with confirmed hypoglycemic events (and number of events) defined as events with concomitant self monitoring of blood glucose (SMBG) < 70 mg/dL | 24 weeks |
| Percent of Participants That Reach Therapeutic Goal (HbA1c ≤ 7%) at Week 24 Without Any Hypoglycaemic Episode (Symptomatic or Not) and Without Any Weight Gain (Variation ≥3% Compared to Baseline) | HbA1c <= 7% without any hypoglycaemic episode (symptomatic or not) and without any weight gain | week 24 |
| Auxerre |
| 89000 |
| France |
| Novartis Investigative Site | Bar-le-Duc | 55012 | France |
| Novartis Investigative Site | Bondy | 93143 | France |
| Novartis Investigative Site | Brest | 29200 | France |
| Novartis Investigative Site | Caen | 14000 | France |
| Novartis Investigative Site | Corbeil-Essonnes | 91100 | France |
| Novartis Investigative Site | Fleury-sur-Orne | 14123 | France |
| Novartis Investigative Site | Maisons-Laffitte | 78600 | France |
| Novartis Investigative Site | Menton | 06500 | France |
| Novartis Investigative Site | Montpellier | 34090 | France |
| Novartis Investigative Site | Paris | 75010 | France |
| Novartis Investigative Site | Rennes | 35203 | France |
| Novartis Investigative Site | Saint-Nazaire | 44600 | France |
| Novartis Investigative Site | Sanary-sur-Mer | 83110 | France |
| Novartis Investigative Site | Strsbourg | 67000 | France |
| Novartis Investigative Site | Toulouse | 31300 | France |
| Novartis Investigative Site | Valence | 26000 | France |
| Novartis Investigative Site | Valenciennes | 59300 | France |
Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Metformin/Vildagliptin + Basal Insulin | Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG |
| BG001 | SU+Metformin + Basal Insulin | Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Percentage of Patients Who Reported at Least One Symptomatic Hypoglycemic Event During the 24 Week Randomized Period in Both Treatment Arms | safety population | Posted | Number | percent of participants | 24 weeks |
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| Secondary | Percentage of Patients Reaching Their Glycemic Target Without Hypoglycemic Events | Glycemic target is defined as Glycated hemoglobin(HbA1c) ≤ 7% | ITT population | Posted | Number | percent of participants | 24 weeks |
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| Secondary | Change From Baseline in HbA1c to Week 24 in Both Treatment Arms | ITT population | Posted | Mean | Standard Deviation | HbA1c percent | Baseline, Week 24 |
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| Secondary | Change From Baseline in Body Weight in Both Treatment Arms | Safety Population | Posted | Mean | Standard Deviation | kg | Baseline, Week 24 |
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| Secondary | Mean Daily Insulin Dose at Week 24 | ITT population | Posted | Mean | Standard Deviation | (U/d) | Week 24 |
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| Secondary | Percentage of Patients With Severe and Confirmed Hypoglycemic Events | Severe hypoglycemic events (and number of events) , defined as events requiring assistance of a third party, and with confirmed hypoglycemic events (and number of events) defined as events with concomitant self monitoring of blood glucose (SMBG) < 70 mg/dL | ITT population | Posted | Number | percent participants | 24 weeks |
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| Secondary | Percent of Participants That Reach Therapeutic Goal (HbA1c ≤ 7%) at Week 24 Without Any Hypoglycaemic Episode (Symptomatic or Not) and Without Any Weight Gain (Variation ≥3% Compared to Baseline) | HbA1c <= 7% without any hypoglycaemic episode (symptomatic or not) and without any weight gain | ITT population | Posted | Number | percent of participants | 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 | Metformin/Vildagliptin + Basal Insulin | Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG | 0 | 21 | 4 | 21 | ||
| EG001 | SU+Metformin + Basal Insulin | Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG | 0 | 21 | 10 | 21 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA | Systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Fatigue | General disorders | MedDRA | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA | Systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Parkinson's disease | Nervous system disorders | MedDRA | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Renal colic | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Cataract operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
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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 (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure Office | Novartis Pharmaceuticals | 862-778-8300 |
| 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 |
| D008687 | Metformin |
| D013453 | Sulfonylurea Compounds |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D014508 | Urea |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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| Male |
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