DIABETES MELLITUS

CRS provides state-of-the-art clinical research in the field of metabolic disorders

Diabetes mellitus – a major challenge for the healthcare systems worldwide

Diabetes mellitus is a global burden and has become one of the major challenges for healthcare systems: About 422 million people suffer from diabetes mellitus and 1.6 million deaths per year are attributed to this metabolic disease – according to the World Health Organization (WHO). The International Diabetes Federation (IDF) estimates that the number of patients with diabetes mellitus will rise to nearly 600 million patients worldwide by 2030.

Besides modestly growing numbers of patients with autoimmune diabetes (type 1 and late onset autoimmune diabetes), diabetes mellitus type 2 is increasing pandemically in most parts of the world.
Type 2 diabetes is a complex and heterogeneous disease, usually complicated by comorbidities such as obesity, insulin resistance, lipid disorders, hypertension. Numerous concomitant complications – e.g., cardiovascular disease, heart failure, stroke, nephropathy, neuropathy, retinopathy – are frequently observed in patients with diabetes mellitus and determine the severe clinical burden of this disease.

During recent years, several new pathways in the pathophysiology of type 2 diabetes have been explored and have become targets for new drug development.

CRS has a broad rage of knowledge and experience and offers a huge spectrum of metabolic investigations

CRS has a broad rage of knowledge and experience, and has adopted many up-to-date methods for analyzing and assessing the pharmacodynamic and clinical effects of metabolic drugs. Thus, CRS offers a huge spectrum of metabolic investigations, supplemented by histological assessments of tissue biopsies from skin, subcutaneous fat, muscle, kidney or liver compartments.

Our methods assessing the metabolic status and metabolic effects include:

• Oral / Intravenous Glucose Tolerance Testing (OGTT / IVGTT)
• Continuous Glucose Monitoring (CGM)
• Standardized Test Meals
• Glucose Clamping / Glucose Clamp (M-value)
• Insulin Resistance Measurements
• HOMA-IR (Homeostasis Model Assessment as an index of Insulin Resistance)
• Quicki (quantitative insulin sensitivity check index)
• Alpha and Beta Cell Function Assessments
• Arginine Test
• Glucagon Test

In collaboration with our partners from high science, we at CRS are able to offer special imaging services, e.g., computer tomography or magnetic resonance imaging. Our partner laboratories offer the measurement of numerous biomarkers and cytokines for the assessment of pharmacodynamic drug effects.

All in all, we are consistently expanding our diagnostic arsenal to always provide most recent and state-of-the-art technologies to explore clinical effects of new drugs or new therapeutic interventions.

CRS bridging preclinical evidence to proof-of-concept in healthy humans or patients with diabetes mellitus

The constant care of a powerful CRS proprietary database of volunteers and patients together with a solid network of collaborating medical specialists and office-based family doctors are the key to our highly effective recruitment of healthy volunteers or patients with type 1 or type 2 diabetes mellitus.

CRS-owned excellent equipped and carefully quality controlled Early Phase Clinical Trial Units are a reliable guarantee for our customers for a conduct of the trial according to all regulatory requirements of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) including the rules for Good Clinical Practise (GCP).

Together with carefully selected external clinical centers of excellence we at CRS can provide a wide range of studies bridging from preclinical evidence to the proof-of-concept in healthy humans or patients with diabetes mellitus.

CRS’ experienced scientists, statisticians, and medical writers can provide essential support in creating powerful study outlines or writing study protocols in preparation of a study, as well as in finalizing study reports and drafting manuscripts for publication in scientific journals after completion of the clinical trial.

A large number of scientific papers published in international peer-reviewed journals are proof of our outstanding expertise in this therapeutic area.

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