| Trial ID: | L6387 |
| Source ID: | NCT02719756
|
| Associated Drug: |
Metformin
|
| Title: |
Effect of SGLT-2 Inhibitor Dapagliflozin on Glycemic Variability in Patients With Diabetes Mellitus Type 2
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus|Hypoglycemic Episodes
|
| Interventions: |
DRUG: Metformin|DRUG: Dapagliflozin|DRUG: Metformin up-titration
|
| Outcome Measures: |
Primary: Dynamics (delta from the baseline) of blood glucose variability - integral index of glycemia (LBGI-HBGI) after 3 months of therapy, 3 months | Secondary: Dynamics (delta from the baseline or % decrease of blood glucose level) of blood glucose variability (ADRR) after 3 months of therapy, 3 months|Dynamics of MAGE after 3 months of therapy, 3 months|Dynamic of glycaemia parameters: % of normoglycemia time after 3 months of therapy, 3 months|Dynamic of glycaemia parameters: % of hyperglycemia time after 3 months of therapy, 3 months|Dynamic of glycaemia parameters: % of hypoglycemia time after 3 months of therapy, 3 months|Dynamics of HbA1c (%) from baseline after 3 months of therapy, 3 months|Percentage of diabetes mellitus patients achieved individual target HbA1c, 3 months
|
| Sponsor/Collaborators: |
Sponsor: Research Clinical Centre of the Russian Railways, JSC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
100
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose:
|
| Start Date: |
2016-04
|
| Completion Date: |
2016-12
|
| Results First Posted: |
|
| Last Update Posted: |
2016-03-25
|
| Locations: |
Research Clinical Centre of the Russian Railways, JSC, Moscow, 125993, Russian Federation
|
| URL: |
https://clinicaltrials.gov/show/NCT02719756
|
