| Trial ID: | L3068 |
| Source ID: | NCT01381926
|
| Associated Drug: |
Exenatide
|
| Title: |
Changes in Bone Turnover With Exposure to a GLP-1 Receptor Agonist
|
| Acronym: |
CMBD
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01381926/results
|
| Conditions: |
Type 2 Diabetes Mellitus|Bone Remodeling
|
| Interventions: |
DRUG: exenatide|DRUG: Saline
|
| Outcome Measures: |
Primary: Determine Changes in Bone Resorption Markers During the Treatment With a GLP-1 Receptor Agonist (Exenatide) Compared to Placebo in Patients With T2DM., Bone reabsorption by bone-specific alkaline phosphatase (BAP) was assessed. Distribution of the Difference between EX/PBO Low/High Dose and Baseline Levels were calculated., Baseline to 20 weeks|Determine Changes in Bone Turnover Markers by Serum N-Telo Peptide During the Treatment With a GLP-1 Receptor Agonist (Exenatide) Compared to Placebo in Patients With T2DM., Bone turnover by Serum N-Telo peptide (NTX) was assessed. Distribution of the Difference between EX/PBO Low/High Dose and Baseline Levels were calculated, Baseline to 20 weeks|Determine Changes in Bone Turnover Markers by Tartrate-Resistant Acid Phosphatase 5b (TRACP5b) During the Treatment With a GLP-1 Receptor Agonist (Exenatide) Compared to Placebo in Patients With T2DM., Bone turnover by Tartrate-Resistant Acid Phosphatase 5b (TRACP5b) was assessed. Distribution of the Difference between EX/PBO Low/High Dose and Baseline Levels were calculated., Baseline to 20 weeks |
|
| Sponsor/Collaborators: |
Sponsor: University of Alabama at Birmingham | Collaborators: Amylin Pharmaceuticals, LLC.
|
| Gender: |
FEMALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
14
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-02
|
| Completion Date: |
2015-08
|
| Results First Posted: |
2017-06-14
|
| Last Update Posted: |
2017-06-14
|
| Locations: |
University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01381926
|
