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Safety laboratories and confirmatory CSF were obtained followed by initiation of study medication according to the randomization schedule.
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Oral metformin therapy was continued unchanged, whereas SU dosages were reduced by 50% at initiation of study treatment and further reduced or discontinued if hypoglycemia occurred or if A1C ≤7.0% (≤53 mmol/mol) was achieved.
Safety and tolerability were assessed by standard methods from initiation of study treatment until ≥28 days after the last dose of study drug.
These standard operating procedures were adapted at each clinical site and reviewed and approved by the Coordinating Center prior to initiation of study enrollment at each site.
ROR assisted with initiation of study project.
Subjects signed consent prior to initiation of study directed activities.
a Within 7 days prior to initiation of study medication.
Distinguishing characteristics of ancillary studies may include the collection of additional measurements (particularly new analyses of existing specimens); the initiation of studies by investigators unaffiliated with the original study; cross-protocol data pooling and analysis; pre-existing participant consent; and pre-existing data context and provenance.
The evaluation of lower dose levels was not planned because when the present study was designed, it was assumed that dose levels 1 and 2 were feasible and well tolerated in the metastatic situation, a hypothesis confirmed by studies published after initiation of our study [ 10- 12].
Method: Health data were collected by questionnaires at initiation of the study and 3 months later.
Both test articles were assayed for lutein content and content uniformity by HPLC before initiation of the study and found to be acceptable.
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