Diabetes

The German Diabetes Study (GDS) investigates how newly diagnosed type 1 or type 2 diabetes develops from onset over 10 years, i.e., over the long-term course. The study is conducted at 7 sites throughout Germany within the framework of the German Center for Diabetes Research (DZD).

General requirements for study participation:

  • Women and men aged 18 - 69 years
  • With newly diagnosed type 1 or type 2 diabetes (<1 year)
  • All forms of treatment (dietary, tablets, injections, insulin therapy) can participate
  • And healthy participants aged 18 - 69 years

https://deutsche-diabetes-studie.de

 

Intermittent Fasting to Improve Insulin Secretion in short IFIS study, which is being conducted at several sites throughout Germany and funded by the German Center for Diabetes Research (DZD). Here, the effect of interval fasting on insulin secretion is being investigated in people with prediabetes, type 2 diabetes, and an increased risk of secondary diseases.

General requirements for study participation:

  • Women and men between the ages of 18 and 70 years
  • BMI between 22 - 45 kg/m2
  • With elevated blood glucose levels but no diabetes yet (prediabetes)
  • Newly manifested type 2 diabetes (diagnosis <5 year)

https://www.dzd-ev.de/forschung/multicenterstudien/ifis/index.html

 

The SURPASS-CVOT study is investigating the long-term effect of therapy with Tirzepatide compared with the GLP-1-only analog dulaglutide on the incidence of cardiovascular events in type 2 diabetics at particularly increased cardiovascular risk. The study drug will be injected subcutaneously (s.c.) 1x weekly by the participant. The study has a duration of 5 years, and the initiator is Eli Lilly.

General requirements for study participation: (recruitment ended)

  • Women and men aged ≥40 years with type 2 diabetes.
  • HbA1c ≥7.0%, ≤10.5%
  • Overweight (BMI ≥25 kg/m²)
  • With diagnosed cardiovascular diseases such as coronary artery disease (CAD), condition after myocardial infarction or stroke

clinicaltrials.gov/ct2/show/NCT04255433

 

The goal of the Diabetes Patient Progress Documentation (DPV) Initiative is to improve outcomes for people with diabetes in routine care through standardized documentation, objective comparison of quality indications, and multicenter treatment research. Data from the anonymized DPV registry are used for therapy research on practice-relevant questions. The network is anchored at the University of Ulm.

https://buster.zibmt.uni-ulm.de/projekte/DPV/

 

REIMAGINE 2 is a drug trial investigating how well CagriSema, compared to semaglutide, cagrilintide and placebo, lowers blood glucose and body weight in people with type 2 diabetes treated with metformin with or without SGLT2 inhibitors. The study will run for 68 weeks and is initiated by Novo Nordisk. 

General requirements for study participation: (recruitment ended)

  • Women and men aged ≥18 years with type 2 diabetes
  • HbA1c ≥7.0%, ≤10.5%
  • Overweight (BMI ≥25 kg/m²)
  • Stable daily dose(s) ≥ 90 days of any of the following antidiabetic drugs or combination drugs: metformin with or without SGLT2 inhibitors

https://www.novonordisk-trials.com/


 

Overweight & Obesity

A study of Tirzepatide versus placebo (preparation without active ingredient) in reducing morbidity and mortality in adults with obesity (SURMOUNT-MMO). The drug trial initiated by Eli Lilly includes 15,000 participants worldwide for up to 5 years.

General requirements for study participation: (recruitment ended)

  • Women and men aged ≥40 years
  • With overweight/obesity ≥BMI 27 kg/m2
  • OR diagnosed with prior cardiovascular diseases such as coronary artery disease (CAD), cerebrovascular disease (e.g., strokes), or peripheral arterial disease (PAD)
  • OR participants who have cardiovascular risk factors such as tobacco use, dyslipidemia, hypertension

clinicaltrials.gov/ct2/show/NCT05556512

 

The Dopamine genetics study will investigate the influence of the drug Bromocriptine on weight loss in relation to the fat mass and obesity (FTO) genotype. Furthermore, effects on body fat content, insulin action in the brain, and other metabolic processes will be investigated. Bromocriptine will be compared to a placebo (preparation without active ingredient).

General requirements for study participation: (recruitment ended)

  • Women and men between 18 - 70 years of age
  • BMI ≥30 kg/m²

www.dzd-ev.de/forschung/multicenterstudien/dag/index.html

 

ATTAIN-2 is a drug trial evaluating the safety and efficacy of a once-daily oral regimen of orforglipron compared to a placebo (preparation without active ingredient) in addition to a healthy diet and physical activity on body weight in overweight or obese people with type 2 diabetes. The study will last approximately 77 weeks and is initiated by Eli Lilly. 

General requirements for study participation: (recruitment ended)

  • Women and men between the ages of ≥18 years
  • BMI ≥27 kg/m²
  • At least one unsuccessful diet attempt in the past
  • Diagnosis of type 2 diabetes with an HbA1c value of ≥7% to ≤10% and stable therapy for at least 90 days before study entry

https://www.clinicaltrials.gov/ct2/show/NCT05872620

 

Arterial vascular disease and chronic inflammation

The ZEUS global clinical trial is investigating whether a new drug called Ziltivekimab reduces the risk of cardiovascular events (e.g., myocardial infarction or stroke) in patients with existing cardiovascular disease, chronic kidney disease, and systemic inflammation. Participants will receive either Ziltivekimab or a placebo (preparation without active ingredient). Initiator is Novo Nordisk.

General requirements for study participation: (recruitment ended)

  • Women and men aged ≥18 years
  • Chronic kidney disease
  • Serum high-sensitivity C-reactive protein (hs-CRP) ≥2 mg/L
  • Evidence of atherosclerotic cardiovascular disease

https://clinicaltrials.gov/ct2/show/NCT05021835

 

Liver disease 

The ESSENCE clinical trial will evaluate whether Semaglutide can improve liver injury and reduce liver-related risks in patients with non-alcoholic steatohepatitis (NASH). The study is sponsored by Novo Nordisk, and participants will participate for a total of 5 years. They will be randomly assigned to receive Semaglutide or a placebo (preparation without active ingredient). The study drugs will be injected under the skin (subcutaneously, s.c.) once a week with an injection pen and self-administered by the participants.

General Requirements for Study Participation: (recruitment ended)

  • Women and men aged ≥18 years
  • Histological evidence of NASH
  • OR histologic evidence of stage 2 or 3 fibrosis according to NASH classification
  • OR histologic evidence of non-alcoholic fatty liver disease with activity score (NAS) ≥4

https://clinicaltrials.gov/ct2/show/NCT04822181

 

This FGF-21 study is investigating whether a combination of two drugs (NNC0194-0499 and Semaglutide) can reduce liver injury in patients with non-alcoholic steatohepatitis (NASH). Both study drugs act in the liver. The study is also investigating a combination of Semaglutide and another weight-loss drug (NNC0174-0833), which may provide another treatment option for NASH. The study duration for participants is approximately 19 months.

General Requirements for Study Participation: (recruitment ended)

  • Women and men aged ≥18 years
  • Histological evidence of NASH
  • OR histologic evidence of stage 2, 3, or 4 fibrosis according to NASH classification
  • OR histologic evidence of non-alcoholic fatty liver disease (NAFLD) with specific parameters

clinicaltrials.gov/ct2/show/NCT05016882

 

Parathyroid disease

 

 

Acromegaly

In 2002, the German Acromegaly Registry was established by the German Society of Endocrinology with the aim of improving the medical care of patients with acromegaly. For this rare disease, only a few data on epidemiology, diagnostics, therapy, and long-term prognosis are available. This information gap will be closed with the help of the registry.

The Acromegaly Registry systematically collects clinical data of patients with acromegaly diagnosed and treated in Germany. To date, the data of more than 3,500 patients have been recorded in a structured manner. The Institute of Endocrinology and Diabetes in Lübeck is one of currently 57 active centers. The data are entered pseudonymously web-based into the database of the German Acromegaly Registry.

https://www.akromegalie-register.de/