drugset / Trial / NCT01381926
Changes in Bone Turnover With Exposure to a GLP-1 Receptor Agonist
Phase 4
Terminated
14 enrolled
University of Alabama at Birmingham
Amylin Pharmaceuticals, LLC. · collab
RandomizedCrossoverDouble-blindTreatment
Summary
The purpose of this study is to determine changes in bone turnover markers and calcitonin following the initiation of exenatide compared to placebo in postmenopausal women wtih type 2 diabetes. Hypothesis 1a: Bone resorption (measured by osteocalcin and bone-specific alkaline phosphatase) will be lower and bone formation (measured by type I collagen crosslinked aminoterminal peptide in urine (Urine NTX)) will be higher when subjects are treated with exenatide compared to when subjects are treated with placebo. Hypothesis 1b: Calcitonin levels will not vary significantly between periods of treatment with exenatide vs. placebo.
Timeline
- Start
- 2011-02
- Primary completion
- 2015-08
- Completion
- 2015-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Exenatide | Peptide | 10 ug | Subcutaneous |