Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes.

ABSTRACT:

Aims

To evaluate dose levels for semaglutide, a glucagon-like peptide-1 analogue approved for the treatment of type 2 diabetes, by examining the effects of demographic factors on efficacy and safety in an exposure-response analysis.

Methods

We analysed data from 1552 adults from four randomized phase III trials of 30 to 56 weeks' duration, investigating once-weekly semaglutide doses 0.5 and 1.0 mg. Exposure-response relationships were investigated using graphical and model-based techniques to assess the two dose levels and subgroups with the highest and lowest exposure and response.

Results

The population had the following demographic characteristics: baseline mean age between 53.2 and 58.4 years, glycated haemoglobin (HbA1c) between 64 and 67 mmol/mol (8.0% and 8.3%)

SUBMITTER: Petri KCC 

PROVIDER: S-EPMC6099226 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature