| Trial ID: | L4272 |
| Source ID: | NCT01193296
|
| Associated Drug: |
Vildagliptin
|
| Title: |
Glycemic Holter Study (Continuous Glucose Monitoring) -
|
| Acronym: |
OPTIMA
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Vildagliptin|DRUG: Sitagliptin
|
| Outcome Measures: |
Primary: Glycemic variability assessed by MAGE (Mean Amplitude of Glycemic Excursion), 8 weeks | Secondary: Glycemic control assessed through CSGM, 8 weeks|Glycemic control assessed by A1C, FPG, PPG and the mean of 6 points self-monitoring of blood glucose (SMBG) at baseline and after 8 weeks, 8 weeks|Unrecognized hypoglycemic periods recorded by CSGM, frequency and duration, 8 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novartis
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
36
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2010-06
|
| Completion Date: |
2011-06
|
| Results First Posted: |
|
| Last Update Posted: |
2012-05-04
|
| Locations: |
Investigative Site, Bondy, France|Investigative Site, Corbeil, France|Investigative Site, Marseille, France|Investigative Site, Nancy, France|Investigative Site, Paris, France|Investigative Site, Toulouse, France|Investigative Site, Venissieux, France
|
| URL: |
https://clinicaltrials.gov/show/NCT01193296
|
