| Trial ID: | L2689 |
| Source ID: | NCT01337440
|
| Associated Drug: |
Udca
|
| Title: |
Efficacy and Safety of Ursodeoxycholic Acid (UDCA) Added to the DPP-4 Inhibitor in People With Type 2 Diabetes and Chronic Liver Diseases
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus|Chronic Liver Disease
|
| Interventions: |
DRUG: UDCA|DRUG: Sitagliptin
|
| Outcome Measures: |
Primary: the difference of haemoglobin A1c (HbA1c) and glycoalbumin (GA), the difference of haemoglobin A1c (HbA1c) and glycoalbumin (GA) treating by Ursodeoxycholic Acid (UDCA)or sitagliptin monotherapy, and combination therapy of both two drugs for 3 monthes., 6 months | Secondary: Change from Baseline in Glucagon-like peptide-1 (GLP-1) response to lipid meal test (fat 55%), 6 months|Change from Baseline in energy expenditure, 6months|Change from Baseline in fasting plasma glucose level, 6months|change from baseline in autonomic nerve function, This is performed by power-spectrum analyses of heart rate variability, 6 months
|
| Sponsor/Collaborators: |
Sponsor: Kanazawa University
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2010-04
|
| Completion Date: |
2013-03
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| Results First Posted: |
|
| Last Update Posted: |
2011-04-18
|
| Locations: |
Internal medicine, Kanazawa university hospital, Kanazawa, Ishikawa, 920-8641, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01337440
|
