---
title: Pharmacokinetics studies of diabetes treatments
description: Profil is experienced in pharmacokinetics studies of insulin and other diabetes drugs and can advise on the trial design.
---

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# [![Pharmacokinetics header](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/Header/Header_1077x260px_CLINICAL_DEVELOPMENT.jpg?width=1077&height=260&name=Header_1077x260px_CLINICAL_DEVELOPMENT.jpg) Pharmacokinetics See why Profil is the perfect partner for pharmacokinetic studies.](https://www.profil.com/services/pharmacokinetics#)

## Extensive experience in pharmacokinetics studies

Profil has performed numerous dose-finding studies investigating the pharmacokinetics (PK) of new or modified drugs, in combination with and without pharmacodynamic profile assessments. We support our clients with advice on the appropriate study design and the potential dose range.

PK describes how the circulating concentration of a medicinal drug changes over time from administration until its elimination. Knowing the PK profile of a drug is important to determine treatment and understand its performance in terms of competitor medications.

It is also an important aspect of identifying potential toxic doses. While toxicity is determined in early preclinical trials, dose-finding studies aim to find the clinically relevant and tolerable dose. Such studies are usually designed as cohort studies that start with a very low dose, gradually increasing to the expected treatment dose and potentially going above it.

The drug-specific PK profile depends on several aspects: route of administration, absorption patterns, distribution in and metabolism by the body, elimination and/or degradation processes, and structural characteristics that potentially affect those processes. For example, insulin pharmacokinetics is highly dependent on specific structural changes (e.g., amino acid changes introduced to insulin analogues) and/or specific excipients such as absorption enhancers.

Pharmacokinetic trials could also answer specific scientific and mechanistic questions. For example, the effect of a drug, such as GLP-1 analogues, on gastric emptying could be determined by an absorption test with acetaminophen.

If you need a partner with world-leading experience in diabetes clinical trials and extensive knowledge about pharmacokinetics of insulin and others diabetes treatments, contact Profil Germany.

![pikto2.png](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Icon_NewWebinar.png?width=62&height=70&name=Icon_NewWebinar.png)

### Online Seminar

Watch our online seminar on moving from preclinical to clinical trials using the example of studying insulin sensitivity.

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![Dr. Grit Andersen](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/content-bilder/Mitarbeiter/Education-Medical-Specialist_Mitarbeiter.png?width=154&height=176&name=Education-Medical-Specialist_Mitarbeiter.png)

### Our expert

**Dr. Grit Andersen**

Director Clinical Pharmacology

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![blank.jpg](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Icon_References.png?width=49&height=49&name=Icon_References.png)

#### References

 We have published with the following sponsors:   
![Referenzen](https://www.profil.com/hubfs/BLUE_MOON/content-bilder/Referenzen.gif "Referenzen")

[View more](https://www.profil.com/knowledge-center/references?hsLang=en-us)

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#### Certificates

| ![13485_Zertifikatssiegel_black_A3](https://www.profil.com/hubfs/BLUE_MOON/piktos/ISO_134852016_certificate_blue.png) ISO 13485:2016 ![27001_Zertifikatssiegel](https://www.profil.com/hubfs/BLUE_MOON/piktos/ISO_27001_certificate_.png) ISO 27001 | ![9001:2015_Zertifikatssiegel](https://www.profil.com/hubfs/BLUE_MOON/piktos/ISO_9001-2015_certificate.png) ISO 9001:2015 ![9001:2015_Zertifikatssiegel](https://www.profil.com/hubfs/BLUE_MOON/piktos/BVMA_Logo_Certificate_size.png) BVMA Member |
| --- | --- |

![blank.jpg](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Icon_Publications.png?width=44&height=49&name=Icon_Publications.png)

#### Publications

Andersen, G. et al. 2020. ADO09, a co-formulation of the amylin analogue pramlintide and the insulin analogue A21G, lowers postprandial blood glucose versus insulin lispro in type 1 diabetes. Diabetes Obes Metab. 2021 Apr;23(4):961-970.

[View all](https://www.profil.com/knowledge-center/publications?hsLang=en-us)

The Profil Institute for Metabolic Research supports clients with advice on study design and dose range in pharmacokinetic investigations of diabetes, prediabetes and obesity medication. Our extensive experience with studies of insulin pharmacokinetics and the pharmacokinetics of other diabetes treatments gives us superior expertise in such studies.

###### Profil Institut für Stoffwechselforschung GmbH

Hellersbergstraße 9 · 41460 - Neuss, Germany  
Telefon +49-2131-4018-345 · marketing@profil.com  
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