| Trial ID: | L3055 |
| Source ID: | NCT02680457
|
| Associated Drug: |
Insulin Degludec
|
| Title: |
Effect of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
Diabetes
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02680457/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Insulin Degludec|DRUG: Insulin Glargine
|
| Outcome Measures: |
Primary: Glycemic Variability: Mean Amplitude of Glucose Excursion (MAGE), Mean amplitude of interstitial glucose excursions (MAGE) during the last 48 h of the ambulatory continuous glucose monitoring of 3 days (Guardian®, Medtronic MiniMed, Northridge); starting in the day 3 of the administration of insulin degludec or glargine, 2 days | Secondary: Glycemic Variability: Area Under the Curve of Glucose, Area under the curve of glucose of the second day of continuous ambulatory glucose monitoring of 3 days (Guardian®, Medtronic MiniMed, Northridge), Every 5 min for 24 hours on day 5 post-dose
|
| Sponsor/Collaborators: |
Sponsor: University of Guadalajara
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
12
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-11
|
| Completion Date: |
2016-11
|
| Results First Posted: |
2020-09-28
|
| Last Update Posted: |
2020-09-28
|
| Locations: |
Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara, Guadalajara, Jalisco, 44340, Mexico
|
| URL: |
https://clinicaltrials.gov/show/NCT02680457
|
