---
title: The world's leading metabolic full-service CRO
description: Profil has become the leading full-service CRO with an exclusive focus on clinical research into diabetes, obesity and related conditions.
---

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[Patient information](https://www.profil.de)

- [Jobs](https://www.profil.com/organization/open-positions)
- [Blog](https://blog.profil.com/blog)

- [Organization](https://www.profil.com/organization) 
    - [About Profil](https://www.profil.com/organization/about-profil) 
          - [Driving innovation in diabetes](https://www.profil.com/organisation/driving-innovation-in-diabetes)
          - [Meet us at conferences](https://www.profil.com/organisation/conferences)
          - [Locations](https://www.profil.com/expansion-us)
          - [News](https://www.profil.com/whats-new-at-profil)
    - [People](https://www.profil.com/organization/people) 
          - [Board of Shareholders](https://www.profil.com/organization/board-of-shareholders)
          - [Holding Management](https://www.profil.com/organization/executive-team)
          - [Scientists](https://www.profil.com/organization/scientists)
    - [Career](https://www.profil.com/organization/career) 
          - [Job profiles](https://www.profil.com/organization/job-profiles)
          - [Open positions](https://www.profil.com/organization/open-positions)
          - [Your Application](https://www.profil.com/organization/your-application)
          - [Training as clinical pharmacologist](https://www.profil.com/organization/medical-specialist)
          - [Training as study nurse](https://www.profil.com/organization/study-nurse)
- [Research Focus](https://www.profil.com/expertise) 
    - [Diabetes treatment](https://www.profil.com/expertise/diabetes-treatment) 
          - [Glucose lowering medication](https://www.profil.com/expertise/glucose-lowering-medication)
          - [Alternative route insulins](https://www.profil.com/expertise/insulin-alternatives)
          - [Insulin analogues](https://www.profil.com/expertise/insulin-analogues)
          - [Diabetes complications](https://www.profil.com/expertise/cardiovascular-complications)
          - [Incretin hormones](https://www.profil.com/expertise/incretins)
    - [Medical technology](https://www.profil.com/expertise/medical-technology-research) 
          - [Insulin pump](https://www.profil.com/expertise/insulin-pump)
          - [Artificial pancreas](https://www.profil.com/expertise/artificial-pancreas)
          - [Glucose meters](https://www.profil.com/expertise/glucose-meter)
          - [Continuous glucose monitoring](https://www.profil.com/expertise/cgm)
    - [Obesity treatment](https://www.profil.com/expertise/obesity-treatment) 
          - [Obesity](https://www.profil.com/expertise/obesity)
          - [Impaired glucose tolerance](https://www.profil.com/expertise/impaired-glucose-tolerance)
          - [MASLD/MASH](https://www.profil.com/expertise/nafld)
          - [Cardiometabolic research](https://www.profil.com/expertise/cardiometabolic-research)
- [Clinical Trial Services](https://www.profil.com/full-service-cro) 
    - [Clinical development](https://www.profil.com/services/development) 
          - [Bioequivalence / biosimilar](https://www.profil.com/services/biosimilar)
          - [Pharmacodynamics](https://www.profil.com/services/pharmacodynamics)
          - [Pharmacokinetics](https://www.profil.com/services/pharmacokinetics)
          - [Bridging studies](https://www.profil.com/services/bridging-study)
          - [Safety and tolerability](https://www.profil.com/services/safety)
    - [Methods](https://www.profil.com/services/methods) 
          - [Glucose clamp](https://www.profil.com/services/hyperinsulinemic-euglycemic-clamp)
          - [Bodpod / body composition](https://www.profil.com/services/bodpod)
          - [Pancreatic clamp](https://www.profil.com/services/pancreatic-clamp)
          - [Stable isotopes / metabolic fluxes](https://www.profil.com/services/stable-isotopes)
          - [Adipose tissue and muscle biopsy](https://www.profil.com/services/muscle-biopsy)
          - [Transient elastography](https://www.profil.com/services/transient-elastography)
          - [Flow-mediated dilation](https://www.profil.com/services/flow-mediated-dilation)
          - [Retinal laser scanner](https://www.profil.com/services/retinal-laser-scanner)
          - [Skin laser Doppler](https://www.profil.com/services/laser-doppler)
          - [Standardized food intake / Nutrition](https://www.profil.com/services/nutrition)
          - [Exercise / energy expenditure](https://www.profil.com/services/exercise-energy-expenditure)
          - [Other methods](https://www.profil.com/services/other-methods)
    - [Further services](https://www.profil.com/services/further-services) 
          - [Patient recruitment](https://www.profil.com/services/patient-recruitment)
          - [GMP certified pharmacy](https://www.profil.com/services/pharmacy)
          - [Data management, statistics and medical writing](https://www.profil.com/services/data-management)
          - [Regulatory handling](https://www.profil.com/services/regulatory-handling)
          - [Clinical development consulting](https://www.profil.com/services/clinical-development-consulting)
- [Knowledge Center](https://www.profil.com/knowledge-center) 
    - [Scientific content](https://www.profil.com/knowledge-center/scientific-content) 
          - [Publications](https://www.profil.com/knowledge-center/publications)
          - [Online Seminars](https://www.profil.com/knowledge-center/online-seminars)
          - [Blog](https://blog.profil.com/blog)
          - [Conference Posters](https://info.profil.com/download-profil-conference-posters)
    - [Diabetes Knowledge](https://www.profil.com/knowledge-center/knowledge) 
          - [Diabetes types](https://www.profil.com/knowledge-center/diabetes-types)
          - [Diabetes prevention](https://www.profil.com/knowledge-center/diabetes-prevention)
          - [Stem cells](https://www.profil.com/knowledge-center/stem-cells)
          - [Trial stages](https://www.profil.com/knowledge-center/trial-stages)

- [Organization](https://www.profil.com/organization?hsLang=en-us)
- About Profil

![Header_1077x400px_Clamp_Art](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/Header/Header_1077x400px_Clamp_Art.jpg?width=1077&height=400&name=Header_1077x400px_Clamp_Art.jpg)

# About Profil

Profil is the world’s leading diabetes and obesity CRO.

## Over 25 years of clinical trial experience

Founded in 1999, Profil is a unique full-service CRO with an excellent record for professional conduct and scientific expertise in clinical research on diabetes and other metabolic diseases.

The Profil Institut für Stoffwechselforschung GmbH (in English Profil Institute for Metabolic Research), began life as a spin-off of the Department of Metabolic Diseases and Nutrition at the [University of Düsseldorf](https://www.uni-duesseldorf.de/home/en/home.html). Our founders wished to create a dedicated CRO that would address the challenges of diabetes and obesity research and treatment. The company’s achievements are a testament to that vision.

Over the years, we have implemented numerous sophisticated methods for [pharmacodynamic characterization](https://www.profil.com/services/pharmacodynamics?hsLang=en-us) of the effects of compounds in early phase trials, and we have been involved in the development of all the currently available major anti-diabetic compounds. Our key competence is the performance of [glucose clamp studies](https://www.profil.com/services/glucose-clamp?hsLang=en-us), often combined with isotope dilution techniques and muscle or fat biopsies.

### Full-service support for clinical trials

Profil is a full-service CRO certified according to ISO 9001:2015 and ISO 13485:2016. We can boast a vast patient database, with over 30,000 people, a dedicated regulatory department, a fully GMP-certified pharmacy and an in-house clinic in Neuss. This clinic has 60+ beds. Thus, we can reliably perform clinical studies within agreed timelines.

In addition to excellent facilities, we provide a unique combination of regulatory and scientific expertise to support clinical trial goals. Our team has over 380 members, including 20 physicians and 1 specialist with a master’s degree in drug regulatory affairs, and our scientific experts are internationally renowned for their contributions in the fields of diabetes, pharmacology, obesity, prediabetes, cardiology, nutrition, and medical technology. This team has to its name over 400 peer-reviewed publications and a significant presence at international diabetes-focused conferences.

Partnership with Profil also means access to our unrivalled portfolio of [state-of-the-art experimental methods](https://www.profil.com/services/methods?hsLang=en-us). Our experts stand ready to [optimize the design of a study](https://www.profil.com/services/clinical-development-consulting?hsLang=en-us) and select the right combination of research methods to deliver the answers needed for the further development of a compound.

### Early phase trials in diabetes and obesity development

With a focus on early phase studies, we pride ourselves on aiding our clients to design the very best clinical trials: optimum participant groups and test environments, best-fit methods, and support for analyses and dissemination of results.

We have considerable experience in working with large pharmaceutical companies that are used to moving compounds through their pipelines as well as small and medium companies who may be working on their first clinical candidate. In our work, we adjust to the needs of the different types of clients. What stays the same is our unrivalled expertise in our core areas of specialization:

**[Pharmacodynamics](https://www.profil.com/services/pharmacodynamics?hsLang=en-us) and [pharmacokinetics](https://www.profil.com/services/pharmacokinetics?hsLang=en-us)**  
We have experience with testing all classes of new and modified anti-diabetic drugs with regard to their pharmacodynamic and pharmacokinetic effects using methods such as glucose clamp, isotope dilution techniques, and muscle or fat biopsies.

[**Safety and tolerability studies**](https://www.profil.com/services/safety?hsLang=en-us)   
Safety and tolerability studies for novel compounds are a core expertise for Profil, making us an ideal partner for first-in-man studies and single or multiple ascending dose studies focused on diabetes or obesity treatment.

[**Bioequivalence trials**](https://www.profil.com/services/biosimilar?hsLang=en-us)  
We’ve performed numerous bioequivalence trials with different insulin formulations and can advise on optimization of study design to ensure that regulatory requirements of the FDA and EMA are met.

[**Bridging studies**](https://www.profil.com/services/bridging-study?hsLang=en-us)  
Data from clinical trials performed at Profil are used and accepted by the authorities for NDAs in Japan. Accelerate your approval process in Japan considerably (from an average of 56 to 32 months) by doing your bridging study with us. We have Japanese staff members to run these studies and our database has 300 Japanese volunteers and can easily be extended.

[**Technology studies**](https://www.profil.com/expertise/medical-technology-research?hsLang=en-us)  
We’re experienced in all aspects of medical technology in the area of diabetes and obesity. We played a leading role in the development of the artificial pancreas and we have a dedicated team for medical device projects. Profil is ISO 13485 certified and has substantial regulatory experience in medical technology trials, including the recent MDR.

 

**Read on to discover more about [Profil services](https://www.profil.com/full-service-cro?hsLang=en-us) and our [expertise in diabetes and obesity](https://www.profil.com/expertise?hsLang=en-us) research. Or else, discover the company behind the name Profil by following the links below.**

![pikto2.png](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Icon_Publications.png?width=44&height=49&name=Icon_Publications.png)

### Online Seminar

 

On-Demand Online Seminar:

**"Understanding the results**

**of glucose clamp studies****"**

 

[![Watch now](https://no-cache.hubspot.com/cta/default/481167/53f3eed6-bc1b-4f4d-9928-2368f1efc934.png)](https://cta-redirect.hubspot.com/cta/redirect/481167/53f3eed6-bc1b-4f4d-9928-2368f1efc934)

![About_Profil_Content](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/content-bilder/About_Profil/About_Profil_Content1.png?width=220&name=About_Profil_Content1.png "About_Profil_Content")

 

[![Take it with you: Download company brochure](https://no-cache.hubspot.com/cta/default/481167/b51dd85b-579c-44b8-adb8-d57c5fc5de30.png)](https://cta-redirect.hubspot.com/cta/redirect/481167/b51dd85b-579c-44b8-adb8-d57c5fc5de30)

[**Events and conferences **

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Meet representatives of Profil Germany at conferences worldwide.

](https://www.profil.com/organisation/conferences?hsLang=en-us)

[**News**

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Read the latest from Profil’s expert scientists and find out about our upcoming events.

](https://www.profil.com/whats-new-at-profil?hsLang=en-us)

[**Driving Innovation in Diabetes**

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Learn how Profil works towards a faster pace of innovation in diabetes and obesity treatment.

](https://www.profil.com/organisation/driving-innovation-in-diabetes?hsLang=en-us)

![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)

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

#### 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

 Heise, T. et al. 2020. Pharmacokinetic and pharmacodynamic bioequivalence of proposed biosimilar MYL-1501D with US and European insulin glargine formulations in patients with type 1 diabetes mellitus. Diabetes Obes Metab. 2020 Apr;22(4):521-529.

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

- [Expertise](https://www.profil.com/expertise) 
    - [Diabetes Treatment](https://www.profil.com/expertise/diabetes-treatment)
    - [Medical Technology](https://www.profil.com/expertise/medical-technology-research)
    - [Obesity](https://www.profil.com/expertise/obesity-treatment)
- [Services](https://www.profil.com/full-service-cro) 
    - [Diabetes Medication Development](https://www.profil.com/services/development)
    - [Methods](https://www.profil.com/services/methods)
    - [Further Services](https://www.profil.com/services/further-services)
- [Knowledge Centre](https://www.profil.com/knowledge-center) 
    - [Publications](https://www.profil.com/knowledge-center/publications)
    - [Online Seminars ](https://www.profil.com/knowledge-center/online-seminars)
    - [Blog](https://blog.profil.com/blog)
    - [Diabetes Knowledge](https://www.profil.com/knowledge-center/knowledge)
- [Organization](https://www.profil.com/organization) 
    - [About Profil](https://www.profil.com/organization/about-profil)
    - [People](https://www.profil.com/organization/people)
    - [Career](https://www.profil.com/organization/career)

Working with Profil CRO means partnership with a dedicated team of scientific and regulatory experts who understand the needs of clinical trials into diabetes and other metabolic diseases. Profil consulting services have helped numerous pharmaceutical companies in the developments of drugs, treatments and medical devices for the treatment of diabetes.

###### Profil Institut für Stoffwechselforschung GmbH

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