| Trial ID: | L5433 |
| Source ID: | NCT01679899
|
| Associated Drug: |
Vildagliptin
|
| Title: |
Effect of Anti-diabetic Drugs on Bone Metabolism and Glycemic Variability
|
| Acronym: |
BoneGlyc
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus|Menopause|Osteoporosis|Osteopenia
|
| Interventions: |
DRUG: Vildagliptin|DRUG: Gliclazide MR
|
| Outcome Measures: |
Primary: Markers of bone remodeling, Primary outcome is to compare the effect of vildagliptin with gliclazide MR on markers of bone remodeling. The outcome variables are the blood levels of: 1. Osteocalcin (OC) 2. Bone-specific alkaline phosphatase (BALP) 3. Carboxy-terminal telopeptide of type I collagen (CTX) 4. Amino-terminal telopeptide of type I collagen (NTX), 6 months | Secondary: Bone mineral density of lumbar spine and femur by X-ray absorptiometry, To compare the effect of vildagliptin with gliclazide MR on bone mineral density of lumbar spine and femur by X-ray absorptiometry after 12-month treatment., 12 months|Glycemic variability, To compare the effect of vildagliptin with gliclazide MR on glycemic variability measured by MAGE method (mean amplitude of glycemic excursion) using a continuous glucose monitoring system, 6 months|Calcitonin, Dosage of serum calcitonin, 12 months | Other: Levels of aminotransferases, Dosage of alanine aminotransferase (ALT, SGOT) and aspartate aminotransferase (AST, SGPT), 6 months
|
| Sponsor/Collaborators: |
Sponsor: Centro de Diabetes Curitiba Ltda
|
| Gender: |
FEMALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
56
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2012-12
|
| Completion Date: |
2015-10
|
| Results First Posted: |
|
| Last Update Posted: |
2016-11-04
|
| Locations: |
Centro de Diabetes Curitiba, Curitiba, Parana, 80810040, Brazil
|
| URL: |
https://clinicaltrials.gov/show/NCT01679899
|
