Determination of capillary blood concentrations of the oral antidiabetics metformin and/or sitagliptin in dried blood spots
| ISRCTN | ISRCTN14518136 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14518136 |
| Secondary identifying numbers | 016/1525 |
- Submission date
- 27/07/2016
- Registration date
- 28/07/2016
- Last edited
- 01/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Institut für Pharmazie und Lebensmittelchemie
Universität Würzburg
Würzburg
97074
Germany
| Phone | +49 (0)931 318 5468 |
|---|---|
| petra.hoegger@uni-wuerzburg.de |
Study information
| Study design | Cross-sectional observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| 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 |
| Study objectives | 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(s) | International Review Board/Independent Ethics Committee Freiburg, 04/07/2016, ref: 016/1525 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/08/2016 |
| Completion date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Target number: 250 participants |
| Key inclusion criteria | 1. Patients with type 2 diabetes mellitus under therapy with metformin and/or sitagliptin 2. Patients older than 18 years |
| Key exclusion criteria | Patients with an infective disease |
| Date of first enrolment | 01/08/2016 |
| Date of final enrolment | 30/11/2016 |
Locations
Countries of recruitment
- Germany
Study participating centre
Am Hubland
Würzburg
97074
Germany
Sponsor information
University/education
c/o Prof. Dr. Petra Högger
Institut für Pharmazie und Lebensmittelchemie Am Hubland
Würzburg
97074
Germany
| petra.hoegger@uni-wuerzburg.de | |
"ROR" |
https://ror.org/03pvr2g57 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2019 | 01/02/2019 | Yes | No |
Editorial Notes
01/02/2019: Publication reference added
12/10/2017: internal review.
