| Trial ID: | L6578 |
| Source ID: | NCT02007278
|
| Associated Drug: |
Vildagliptin And Metformin (Combination)
|
| Title: |
Glycemic Excursions in Type 2 Diabetic Patients With Vildagliptin and Metformin Versus Vildagliptin and Glimepiride
|
| Acronym: |
GLOBE
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02007278/results
|
| Conditions: |
Type 2 Diabetes|Hypoglycemia
|
| Interventions: |
DRUG: vildagliptin and metformin (combination)|DRUG: glimepiride|DRUG: Metformin
|
| Outcome Measures: |
Primary: Glycemic Variability Measured by Mean Amplitude of Glucose Excursions (MAGE), Mean Amplitude of Glycemic Excursions (MAGE) , which determines the average blood glucose excursions either above or below a value of one standard deviation of the average value of glucose in a given day. MAGE is calculated from the data of continuous tissue glucose monitoring obtained during the measurement period. MAGE is calculated with the formula Σ λ / χ if λ\> ν (where λ = changes in blood glucose from peak to nadir, χ = number of valid observations, ν = 1 standard deviation of the mean glucose during a period of 24 hours) from the data of continuous monitoring of the tissue glucose, obtained during the period of measurement., Week 12 | Secondary: Glycemic Variability Measured by Continuous Overlapping Net Glycemic Action (CONGA), Continuous Overlapping Net Glycemic Action (CONGA) which assesses intra-day glycemic variability by calculating the difference between values at different intervals, adjusted according to requirements with the advantage of being highly reproducible. CONGA is calculated in the conventional way with the formula √tқΣt = t1 (Dt -Ď2) / қ - 1, Ď = tқ Σ Dt t = t1 / қ, Dt = Gt-Gt-m (where қ = Observations with an observation n x 60 minutes, G = glucose measure) from the data of continuous monitoring of tissue glucose obtained during the measurement period., Week 12|Glycemic Variability Measured by Total Standard Deviation (TSD), Total standard deviation (TSD) or standard deviation of all values of a given measurement period, which has the advantage of being able to include all measured values on a given time period (even several days) through a common and simple statistical concept. TSD is calculated conventionally with the formula σ = √Σ (Xi - ῦ) 2 / N (where Xi represents each of the values, ῦ represents the population mean and N is the number of observations) from the data of continuous monitoring of tissue glucose obtained during the measurement., Week 12|Percentage of Patients Who Achieved a Decrease Equal to or Greater Than 0.3% in Value of HbA1c at Week 12, Screening visit , 12 weeks of treatment|Change in HbA1c at Week 12 of Treatment in Comparison to HbA1c at Baseline, baseline, 12 weeks of treatment|Number of Patients With Incidence of Hypoglycemia, Hypoglycemia defined as Glycemia \< 70 mg/dl, 12 weeks|Mean Amplitude of Glycemic Excursions (MAGE) for Patients With Hypoglycemia Incidence After 12 Weeks of Treatment, MAGE , which determines the average blood glucose excursions either above or below a value of one standard deviation of the average value of glucose in a given day. MAGE is calculated from the data of continuous tissue glucose monitoring obtained during the measurement period. MAGE is calculated with the formula Σ λ / χ if λ\> ν (where λ = changes in blood glucose from peak to nadir, χ = number of valid observations, ν = 1 standard deviation of the mean glucose during a period of 24 hours) from the data of continuous monitoring of the tissue glucose, obtained during the period of measurement. In this endpoint, mean MAGE value is reported for hypo glycemic patients., 12 weeks|Number of Patients With Any Adverse Events, Serious Adverse Events and Death, 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2014-01-03
|
| Completion Date: |
2016-02-22
|
| Results First Posted: |
2017-07-11
|
| Last Update Posted: |
2017-07-11
|
| Locations: |
Novartis Investigative Site, Medellín, Antioquia, Colombia|Novartis Investigative Site, Manizales, Caldas, 1700, Colombia|Novartis Investigative Site, Bogotá, Cundinamarca, Colombia|Novartis Investigative Site, Chía, Cundinamarca, 11001000, Colombia|Novartis Investigative Site, Cali, Valle del Cauca, 760001, Colombia|Novartis Investigative Site, Bogotá, 00000, Colombia|Novartis Investigative Site, Cali, Colombia|Novartis Investigative Site, Monteria, Colombia
|
| URL: |
https://clinicaltrials.gov/show/NCT02007278
|
