Changes in Bone Turnover With Exposure to a GLP-1 Receptor Agonist (CMBD)
|ClinicalTrials.gov Identifier: NCT01381926|
Recruitment Status : Terminated (unavailability of study drug and matching placebo)
First Posted : June 27, 2011
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
University of Alabama at Birmingham
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Amy H. Warriner, University of Alabama at Birmingham
|Study Design||Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment|
Type 2 Diabetes Mellitus
|Recruitment Details||Protocol open to accrual: February 2011, primary completion date, August 2015 and study completion date August 2015. Recruitment location at UAB. Postmenopausal women with diabetes mellitus on no medications or metformin alone were recruited from a single outpatient clinic setting.|
|Pre-assignment Details||Potential participants attended a screening visit to ensure they met inclusion/exclusion criteria. If they were on metformin at the screening visit, it was discontinued. They returned in 1 month for the baseline visit and randomization.|
Study was closed due to unavailability of study drug/matching placebo prior to recruitment of target participants. The original drug company was bought and new company was unwilling to supply medication. Small participant number limits data analysis.