Überblick über unsere Studien.

Laufende Studien:

 

A Phase 3 Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn’s Disease. 

I6T-MC-AMAX

A Randomized, Double-blind, Phase 3 Trial to Assess Clinical Efficacy, Safety and Reactogenicity of the Recombinant MVA-BN® -RSV Vaccine in Adults60 Years of Age 

RSV-MVA-004

A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL Combined With Insulin Aspart, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin. COMBINE 3

NN1535-4593

ZEUS – Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation

EX6018-4758

Effectiveness and safety of once weekly insulin icodec used with DoseGuide versus once daily basal insulin analogues in an insulin naïve type 2 diabetes population in a clinical practice setting

NN1436-4481

Efficacy and safety of oral semaglutide 50 mg once daily in subjects with overweight or obesity

NN9932-4737 

Efficacy and safety of once-daily oral semaglutide 25 mg and 50 mg compared with 14 mg in subjects with type 2 diabetes

NN9924-4635

A Randomized, Phase 3, Open-label Trial Comparing the Effect of the Addition of Tirzepatide Once Weekly versus Insulin Lispro (U100) Three Times Daily in Participants with Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) with or without Metformin

I8F-MC-GPHD

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn’s Disease

I6T-MC-AMAM

The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes (SURPASS-CVOT)

I8F-MC-GPGN

SELECT – Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity

EX9536-4388

Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes

EX9924-4473

Pemafibrate to reduce cardiovascular outcomes by reducing Triglycerides In patients with diabetes (PROMINENT)

K-877-302

Abgeschlossene Studien:

 

 

Kooperationsprojekt mit dem VDBD und der Universitätsklinik Jena Entwicklung und Evaluation eines Schulungsprogramms für Angehörige von Menschen mit Diabetes mellitus (Finanzielle Förderung aufgrund eines Beschlusses des Bundestages durch die Bundesregierung).

 

A Phase 2, Randomized, Parallel, Open-Label Comparator-Controlled Trial to Evaluate the Safety and Efficacy of LY3209590 in Study Participants With Type 1 Diabetes Mellitus Previously Treated With Multiple Daily Injection Therapy

I8H-MC-BDCP

A Phase 2, Parallel, Comparator-Controlled Trial to Evaluate the Safety and Efficacy of LY3209590 in Insulin-Naïve Patients with Type 2 Diabetes Mellitus

I8H-MC-BDCL

A 12-week randomized controlled trial to compare TOUJEO® and TRESIBA® in terms of glucose values in target range and variability during continuous glucose monitoring in patients with type 1 diabetes mellitus

LPS14947

A Randomized, Double-Blind Study with an Open-Label Extension Comparing the Effect of Once-Weekly Dulaglutide with Placebo in Pediatric Patients with Type 2 Diabetes Mellitus

H9X-MC-GBGC

A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog With an Open-Label Postprandial LY900014 Treatment Group in Children and Adolescents With Type 1 Diabetes

I88-MC-ITSB

Immunogenicity and Safety of a High-Dose Quadrivalent Influenza Vaccine Administered by the Intramuscular Route in Subjects 60 Years of Age and Older

QHD00011

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Efpeglenatide on Cardiovascular Outcomes in Type 2 DiabetesPatients at High Cardiovascular Risk

EFC14828

A Randomized, Phase 3, Double-blind Trial Comparing the Effect of the Addition of Tirzepatide versus Placebo in Patients with Type 2 Diabetes Inadequately Controlled on Insulin Glargine with or without Metformin (SURPASS-5)

I8F-MC-GPGI 

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Effects of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes, Cardiovascular Risk Factors and Moderately Impaired Renal Function

EFC-14875

A Trial Comparing NNC0148-0287 C (Insulin 287) Versus Insulin Glargine U100, Both in Combination With Metformin, With or Without DPP4 Inhibitors and With or Without SGLT2 Inhibitors, in Basal Insulin Treated Subjects With Type 2 Diabetes Mellitus

NN1436-4466

Effect of Semaglutide Once-weekly Versus Insulin Aspart Three Times Daily, Both as Add on to Metformin and Optimised Insulin Glargine (U100) in Subjects With Type 2 Diabetes A 52-week, Multi-centre, Multinational, Open-label, Active-controlled, Two Armed, Parallel-group, Randomised Trial in Subjects With Type 2 Diabetes

NN9535-4386

A trial comparing NNC0148-0287 C (insulin 287) versus insulin glargine U100, both in combination with metformin, with or without DPP4 inhibitors and with or without SGLT2 inhibitors, in insulin-naïve subjects with type 2 diabetes mellitus

NN1436-4465

A Prospective, Randomized, Double Blind Comparison of LY900014 to Humalog in Adults with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion

I8B-MC-ITRO

A 26-week open-label study assessing the efficacy and safety of the insulin glargine/lixisenatide fixed ratio combination in adults with Type 2 Diabetes inadequately controlled on GLP-1 receptor agonist and metformin ± pioglitazone, followed by a ficed ratio combination single-arm 26-week etnsion period.

EFC 13794

A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro, Both in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 2 Diabetes PRONTO-T2D

PRONTO-T2D

A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro with an Open-Label Postprandial LY900014 Arm, in Combination with Insulin Glargine or Insulin Degludec in Adults With Type 1 Diabetes PRONTO-T1D

PRONTO-T1D

A Phase IIb, Randomised, Parallel, Double-Blind Placebo-Controlled and Open-Label Active Comparator Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects with Type 2 Diabetes Mellitus

D5670C00004 MEDI 0382

Six-month, Randomized, Open-label, Parallel-group Comparison of SAR341402 to NovoLog®/NovoRapid® in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine, with a 6-month Safety Extension Period

EFC 15081

A Study of the Safety and Effectiveness of Benralizumab to Treat Patients With Severe Uncontrolled Asthma. (ANDHI)

D3250C00045

A 28-week, multi-center randomized, double-blind, placebo-controlled study to evaluate the potential of Dapagliflozin plus Exenatide in combination with high-dose intensive insulin therapy compared to Placebo in obese insulin-resistant patients with Type 2 Diabetes mellitus (Proof-of-concept study)

ESR-16-12160/UKE-DapEx-001

Efficacy and Safety of Oral Semaglutide versus Liraglutide and versus Liraglutide and versus Placebo in Subjects with Type 2 Diabetes Mellitus. A 52 – week randomised, double-blind, active-and placebo-controlled trial

NN9924-4224

 

A trial investigating the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes

NN9924-4221

A 26-week open-label study assessing the efficacy and safety of the insulin glargine/lixisenatide fixed ratio combination in adults with Type 2 Diabetes inadequately controlled on GLP-1 receptor agonist and metformin ± pioglitazone, followed by a ficed ratio combination single-arm 26-week extesion period

EFC 13794

Six-month, Randomized, Open-label, Parallel-group Comparison of SAR341402 to NovoLog®/NovoRapid® in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine, with a 6-month Safety Extension Period

EFC 15081

Efficacy and Safety of Faster-acting Insulin Aspart compared to NovoRapid both in Combination with Insulin Degludec in Children and Adolescents with Type 1 Diabetes

NN1218-4101

 

A Randomized, Parallel-Arm, Double-Blind Study of Efficacy and Safety of Dulaglutide When Added to SGLT2 Inhibitors in Patients with Type 2 Diabetes Mellitus

H9X-MC-GBGE

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects with Type 1 Diabetes Mellitus-Study Two

MB 102230

A21-week, open-label, randomized,controlled, parallel-group, multi-center study evaluating the efficacy and safety of HOE901-U300 administered according to a device-supported treat-to-target regimen versus routine titration in T2DM patients

HOE901-EFC13470

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab in Insulin Treated Patients with Type 1 or Type Diabetes and With Hypercholesterolemia at High Cardiovascular Risk Not Adequately Controlled on Maximally Tolerated LDL-C Lowering Therapy

LPS14355

A twenty- six week, randomized, open-label, 2-arm parallel group real world pragmatic trial to assess the clinical and health outcomes benefit of Toujeo compared to standard of care insulin for initiating basal insulin in insulin naive patients with uncontrolled type 2 diabetes mellitus, with 6-month extension

LPS 13931

 

A Randomized, Open Label, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab versus Usual Care in Patients with Type 2 Diabetes and Mixed Dyslipidemia at High Cardiovascular Risk with Non-HDL-C Not Adequately Controlled with Maximally Tolerated Statin Therapy

LPS 14354

A 52-week, double-blind, randomised, multi-centre, phase III, parallel-group study in patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort (budenoside/formoterol) Turbohaler 160/4,5 µg “as needed” compared with Pulmicort (budenoside) Turbohaler 0,4 mg “as needed”.

D589SC00003

A 52-week, multi-centre, randomised, parallel-group, double-blind, active-controlled, phase IV study to evaluate the safety and efficacy of Dapagliflozin or Dapagliflozin plus Saxagliptin compared with Sulfonylurea all given as add-on therapy to Metformin in adult patient with type 2 diabetes who have inadequate control on Metformin monotherapy

D1689C00014

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects with Type 1 Diabetes Mellitus

Development and Evaluation

MB102-229

„Development and Evaluation of an evidence-based shared making programme for prevention of myocardial infarction in type 2 diabetes“ Projektleitung: Dr. phil. Matthias Lenz, Universität Hamburg, Fachbereich Gesundheitswissenschaften.

 

Diabetesversorung im ländlichen Raum. Ein Versorgungsforschungsprojekt zum Einfluss der Betreuung durch Diabetesberater in strukturschwachen Gebieten auf die Versorgungsqualität von Menschen mit Diabetes

 

A long-term, randomized, double-blind, placebo-controlled, multinational- multi-centre trial to evaluate cardiovascular and other long term outcomes with semaglutide in subjects with type 2 diabetes. Trial phase: 3a.

NN9535-3744

Efficacy and safety of semaglutide once-weekly versus exenatide ER 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes.

NN9535-3624

LEADER™ (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results). Along-term, multicentre, international, randomised, double-blind, placebo-controlled, phase 3b trial – 2010

 

A randomized, open-label,2-arm parallel-group, multicenter, 26-week study assessing the safety and efficacy of HOE901-U300 versus Lantus in older patients with type 2 diabetes inadequately controlled on antidiabetic regimes either including no insulin, or with basal insulin as their only insulin 

EFC13799 SENIOR

Onset1. Efficacy and safety of FiAsp compared to insulin aspart both in combination with insulin detemir in adults with type 1 diabetes.

NN1218-3852

Eine multizentrische, doppelt-blind, aktivkontrollierte Parallelgruppenstudie zur Untersuchung der Wirksamkeit und Verträglichkeit von LCZ696 gegenüber Enalapril in Hinblick auf Morbidität und Mortalität bei Patienten mit chronischer Herzinsuffizienz und reduzierter Ejektionsfraktion – Abgeschlossen seit 2014

CLCZ696B2314

A randomized study to compare safety and efficacy of vildagliptin versus NPH insulin add-on to glimepiride in patients with type 2 diabetes mellitus that do not reach adequate glycemic control on their current sulfonylurea monotherapy.

CLAF237ADE08

 

The effect of liraglutide when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes. A 26-week double-blind placebo-controlled randomized multicentre, multinational parallel-group trial.versus placebo 

NN2211-3917

Prävalenz gestörter Atmung im Schlaf bei Patienten mit Beinvenenthrombose / Lungenembolie. Eine prospektive multizentrische Querschnittsuntersuchung der AG Kreislauf und Schlaf der DGSM – 2009

TRANS-North study

Phase III, double-blind, placebo controlled, parallel group, international, multicenter studie of 12 weeks treatment with trafermin 0,01% spray in patients with diabetic foot ulcer of neuropathic origin. 2011 – 2012