Plain English Summary
Background and study aims
Diabetes is a lifelong condition that causes a person's blood sugar (glucose) level to become too high. Many patients with type 2 diabetes take the drugs metformin and/or sitagliptin to control their blood glucose levels. Although these medications are frequently prescribed it is widely unknown which typical blood levels of these drugs are found under "real-life" conditions, i.e. in patients taking additional other drugs such as blood-pressure lowering drugs or in patients with decreased kidney function. Knowledge of the blood levels of metformin and/or sitagliptin in a big group of patients might allow us to identify factors that influence those levels. The aim of this study is to determine the blood levels of metformin and/or sitagliptin in patients with type 2 diabetes, and to find factors which might influence those levels.
Who can participate?
Patients older than 18 with type 2 diabetes treated with metformin and/or sitagliptin
What does the study involve?
The participants’ blood levels of metformin and/or sitagliptin are determined using a new approach which requires a small amount of blood obtained by finger pricking. The blood samples are collected in community pharmacies in Germany. The blood is spotted onto a filter paper and dried, then sent to the University of Würzburg for analysis of the drug levels.
What are the possible benefits and risks of participating?
If unusually high or low blood concentrations of metformin and/or sitagliptin are found, then the participant will be informed via the participating pharmacy. The patient can then contact his/her physician who might determine appropriate measures. In future, the results of this study might help to simplify and/or improve diabetes treatment. There are no particular risks associated with participating in the study. The procedure involves finger pricking and collection of capillary blood similar to the procedure for routine blood glucose measurement. This should be familiar for patients with type 2 diabetes.
Where is the study run from?
Universität Würzburg (Germany)
When is the study starting and how long is it expected to run for?
August to December 2016
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Petra Högger
petra.hoegger@uni-wuerzburg.de
Trial website
Contact information
Type
Scientific
Primary contact
Prof Petra Högger
ORCID ID
Contact details
Institut für Pharmazie und Lebensmittelchemie
Universität Würzburg
Würzburg
97074
Germany
+49 (0)931 318 5468
petra.hoegger@uni-wuerzburg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
016/1525
Study information
Scientific title
Cross-sectional study to determine real-life concentrations of metformin and/or sitagliptin in patients with type 2 diabetes in dried blood spots
Acronym
Study hypothesis
Typical real-life blood concentrations of metformin and/or sitagliptin, e.g. in patients under polypharmacotherapy, are widely unknown and might be dependent on kidney function and/or co-medication regimes. The aim of this study is to determine the real-life concentrations of metformin and/or sitagliptin in patients with type 2 diabetes in dried blood spots, and to find potential co-variates which might influence the concentrations, such as estimated kidney function or co-medication.
Ethics approval
International Review Board/Independent Ethics Committee Freiburg, 04/07/2016, ref: 016/1525
Study design
Cross-sectional observational study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Type 2 diabetes mellitus
Intervention
Capillary blood of type 2 diabetic patients will be collected in participating community pharmacies. The blood will be spotted on a filter paper, dried and sent for analysis of metformin, sitagliptin and creatinine concentrations. Concentrations will be analysed in relation to the estimated kidney function using the Cockroft-Gault formula.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Metformin and/or sitagliptin concentrations in capillary blood samples using the dried blood-spot technique
Secondary outcome measures
Potential co-variates which might influence the concentrations such as estimated kidney function or co-medication
Overall trial start date
01/08/2016
Overall trial end date
31/12/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with type 2 diabetes mellitus under therapy with metformin and/or sitagliptin
2. Patients older than 18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Target number: 250 participants
Participant exclusion criteria
Patients with an infective disease
Recruitment start date
01/08/2016
Recruitment end date
30/11/2016
Locations
Countries of recruitment
Germany
Trial participating centre
Coordinating centre: Universität Würzburg
Institut für Pharmazie und Lebensmittelchemie
Am Hubland
Würzburg
97074
Germany
Sponsor information
Organisation
Universität Würzburg (Germany)
Sponsor details
c/o Prof. Dr. Petra Högger
Institut für Pharmazie und Lebensmittelchemie Am Hubland
Würzburg
97074
Germany
-
petra.hoegger@uni-wuerzburg.de
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The results of the study, including a detailed description of the study procedures, are planned to be published after finalization of the study and analysis of all samples.
Intention to publish date
31/12/2017
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
1. 2019 results in https://doi.org/10.1007/s00228-019-02637-w (added 01/02/2019)