Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/07/2016
Date assigned
28/07/2016
Last edited
28/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 measures

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

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

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes