| Trial ID: | L3254 |
| Source ID: | NCT01862263
|
| Associated Drug: |
Vildagliptin
|
| Title: |
Effect of 13-Week Treatment With Vildagliptin as Add-On Therapy to Improve Glucose Variability in Type II Diabetes
|
| Acronym: |
VIDA
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Vildagliptin|DRUG: Insulin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Percentage of patients with hyperglycemic events evaluated with CGM, An hypoglycemic event is defined as any continuous glucose monitoring (CGM) measurement less than 60 mg/dL and a hyperglycemic is define as any CGM greater than 140 mg/dL., At 13 weeks | Secondary: Number of hypoglycemia and/or hyperglycemia measured by CGM, An episode of hypoglycemia is defined as any value of glucose under 60 mg/dL, an episode of hyperglycemia is defined as any value of glucose above 140mg/dL measured by CGM., 13 weeks|Area under the curve (AUC 0-24) of the excursions of glucose values below 60 mg/dl per day, Duration and intensity of hypoglycemic episodes, measured as area under the curve (AUC 0-24) of the excursions of glucose values below 60 mg/dl per day, measured by continuous glucose monitoring, 0 to 24 hours daily for week 1, 4 and 13|Average of insulin units per day administered during the study, Change from baseline, 13 weeks|Changes from the baseline in Lipid Profile, Lipid Profile will include total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol, Baseline, 13 weeks|Change from baseline in Body weight, Weight will be measured on Kg., Baseline, 13 weeks|Change from baseline in Blood pressure (BP),, BP will be mesured on mmHg, Baseline, 13 weeks|Change from baseline in Fasting plasma glucose (FPG),, FPG will be measured on mg/dL, Baseline, 13 weeks|Change from baseline in Hemoglobin A1C (HbA1c), HbA1c will be measured on %, Baseline, 13 weeks|Change from baseline in Creatinine, Creatinine will be measured on mg/dL, Baseline, 13 weeks|Change from baseline in C-peptide, C-Peptide will be measured on microIU/mL, Baseline, 13 weeks|Changes from baseline in alanine aminotransferase (ALT)/aspartate aminotransferase (AST), ALT/AST will be measured on ratio., Baseline, 13 week|Changes from baseline in Direct bilirubin, Bilirubin will be measure on mg/dL, Baseline, 13 weeks|Changes from baseline in Body Mass Index (BMI), Baseline, 13 weeks|Number of patients with adverse events, serious adverse events and death as evaluation of safety and tolerability of coadministration of vildagliptin with insulin, 13 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
191
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-05
|
| Completion Date: |
2015-07
|
| Results First Posted: |
|
| Last Update Posted: |
2019-06-05
|
| Locations: |
Novartis Investigative Site, Mexico, Distrito Federal, 06700, Mexico|Novartis Investigative Site, Mexico, Distrito Federal, 07300, Mexico|Novartis Investigative Site, Mexico, Distrito Federal, 14050, Mexico|Novartis Investigative Site, Metepec, Estado De México, 52140, Mexico|Novartis Investigative Site, Celaya, Guanajuato, 38000, Mexico|Novartis Investigative Site, Guadalajara, Jalisco, 44150, Mexico|Novartis Investigative Site, Guadalajara, Jalisco, 44600, Mexico|Novartis Investigative Site, Guadalajara, Jalisco, 44670, Mexico|Novartis Investigative Site, Monterrey, Nuevo Leon, 64710, Mexico|Novartis Investigative Site, Monterrey, Nuevo León, 64020, Mexico|Novartis Investigative Site, Cancun, Quintana Roo, 77500, Mexico|Novartis Investigative Site, Culiacán, Sinaloa, 80000, Mexico|Novartis Investigative Site, Puebla, 72190, Mexico
|
| URL: |
https://clinicaltrials.gov/show/NCT01862263
|
