Clinical trial NCT02443155: A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function
Official title: A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Multi-centre Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2015-05-13
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted globally. The aim of this trial is to assess the clinical proof-of-principle of NNC0114-0006 and liraglutide on preservation of beta-cell function in adult subjects with newly diagnosed type 1 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* T1DM (type 1 diabetes mellitus) (as diagnosed clinically) for not more than 20 weeks prior to screening - Male or female, aged 18-45 (both inclusive) at the time of signing the informed consent form
* Non-fasting peak C-peptide higher or equal to 0.2 nmol/l at visit 2
* BMI (body mass index) higher or equal to 18.5 kg/m\^2
* Presence of one or more islet specific auto antibodies (glutamic acid decarboxylase (GAD), islet antigen-2 (IA2) or zinc-transporter 8 (ZnT8)) at screening
* Insulin dependence unless in temporary spontaneous remission (honeymoon period)

Exclusion Criteria:

* Daily insulin usage above 1 U/kg per day at screening or use of continuous subcutaneous insulin infusion (CSII)
* History of recurrent (e.g. several times a year) of severe (e.g. pneumonia) or chronic infections or conditions predisposing to chronic infections (e.g., bronchiectasis and chronic osteomyelitis)
* History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate documented therapy
* Vaccination within 4 weeks before randomisation, Visit 3 (V3)
* Receipt of any other concomitant medications or herbal products that can influence the immune system within 90 days prior to screening (V1)
* History of pancreatitis (acute or chronic)
* Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
* Any past or current diagnosis of malignant neoplasms
* Known impairment of the immune system, except for T1DM, coeliac disease, alopecia, autoimmune antibodies not considered clinical important (e.g. thyroid antibodies without any clinically important thyroid disease), and vitiligo

Primary outcomes:
measure: Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline
timeFrame: 0 - 4 hours post-dose on week 0 and week 54
Secondary outcomes:
measure: AUC0-2h of C-peptide at Week 54 Relative to Baseline
timeFrame: 0-2 hours post-dose on week 0 and week 54
measure: Cmax of C-peptide at Week 54 Relative to Baseline
timeFrame: 0-4 hours post-dose on week 0 and week 54
measure: AUC0-4h of Glucose at Week 54 Relative to Baseline
timeFrame: 0 - 4 hours post-dose on week 0 and week 54
measure: AUC0-2h of Glucose at Week 54 Relative to Baseline
timeFrame: 0-2 hours post-dose on week 0 and week 54
measure: Cmax of Glucose at Week 54 Relative to Baseline
timeFrame: 0-4 hours post-dose on week 0 and week 54
measure: Number of Treatment Emergent Adverse Events
timeFrame: Week 0-54; Week 54-80
measure: Number of Treatment Emergent Hyperglycaemic Episodes
timeFrame: Week 0-54; Week 54-80
measure: Number of Treatment Emergent Episodes of Diabetic Ketoacidosis
timeFrame: Weeks 0-54; Weeks 54-80
measure: Number of Participants Experiencing Treatment Emergent Injection/Infusion Site Reactions Caused by NNC0114-0006/Liraglutide/Placebo Injection/Infusion
timeFrame: Week 0-54
measure: Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA)
timeFrame: Weeks 0-54; Weeks 54-80
measure: Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions
timeFrame: Weeks 0-54; Weeks 54-80
measure: Change in Body Weight (kg)
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Diabetes Retinopathy
timeFrame: Baseline, week 54 and week 80
measure: Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Haematology: Erythrocytes
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Haematology: Haematocrit
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Haematology: Haemoglobin
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Haematology: Leukocytes
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Haematology: Mean Corpuscular Hemoglobin
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Haematology: Mean Corpuscular Hemoglobin Concentration
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Haematology: Mean Corpuscular Volume
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Haematology: Thrombocytes
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Haematology: Eosinophil
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Haematology: Neutrophils
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Haematology: Basophils
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Haematology: Lymphocytes
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Haematology: Monocytes
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Biochemistry: Alanine Aminotransferase (ALAT)
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Biochemistry: Albumin
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Biochemistry: Amylase
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Biochemistry: Alkaline Phosphatase (ALP)
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Biochemistry: Aspartate Aminotransferase (ASAT)
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Biochemistry: Total Bilirubin
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Biochemistry: Calcium Corrected
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Biochemistry: Chloride
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Biochemistry: Creatine Kinase
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Biochemistry: Creatinine
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Biochemistry: Gamma-glutamyl Transferase (GGT)
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Biochemistry: C-reactive Protein Serum
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Biochemistry: Lactate Dehydrogenase
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Biochemistry: Lipase
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Biochemistry: Magnesium
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Biochemistry: Phosphate
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Biochemistry: Potassium
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Biochemistry: Sodium
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Biochemistry: Total Protein
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Biochemistry: Blood Urea Nitrogen Serum
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Biochemistry: Uric Acid
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in International Normalised Ratio (INR)
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in D-Dimer
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Lipids: Total Cholesterol (Ratio to Baseline)
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Lipids: Free Fatty Acids (Ratio to Baseline)
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Lipids: HDL Cholesterol (Ratio to Baseline)
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Lipids: LDL Cholesterol (Ratio to Baseline)
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Lipids: Triglycerides (TG) (Ratio to Baseline)
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Total Immunoglobulin E (IgE)
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Urinalysis: Urine Dipsticks
timeFrame: Week 0, week 54 and week 80
measure: Change in Cytokines: Interleukin (IL)-6
timeFrame: Week 0, week 54 and week 80
measure: Change in Cytokines- Interleukin (IL)-10
timeFrame: Week 0, week 54 and week 80
measure: Change in Cytokines: Interleukin (IL)-17
timeFrame: Week 0, week 54 and week 80
measure: Change in Cytokines: Interferon (IFN) Gamma
timeFrame: Week 0, week 54 and week 80
measure: Change in Cytokines: TNF-alpha
timeFrame: Week 0, week 54 and week 80
measure: Change in Hormone Level: Thyroid Stimulating Hormone (TSH)
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Hormone Level: Calcitonin
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Systolic and Diastolic Blood Pressure
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Pulse
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Body Temperature
timeFrame: Week 0, week 54) and (week 0, week 80)
measure: Change in Respiratory Rate
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Electrocardiogram (ECG)
timeFrame: Week 0, week 54 and week 80
measure: Change in Eye-examination
timeFrame: Week 0, week 54 and week 80
measure: Change in Physical Examination
timeFrame: Week 0, week 54 and week 80
measure: Occurrence of Anti-NNC0114-0006 Antibodies
timeFrame: Week 0, week 54 and week 80
measure: Occurrence of Anti-liraglutide Antibodies
timeFrame: Week 0, week 54 and week 80
measure: Change in Insulin Dose
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Number of Insulin Injections
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Number of Weeks Off Bolus Insulin
timeFrame: (Week 0 to week 54) and (week 0 to week 80)
measure: Change in HbA1c
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Fasting Plasma Glucose
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Fasting C-peptide- Ratio to Baseline
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Fasting Glucagon- Ratio to Baseline
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: 7-point SMPG Profiles
timeFrame: Week 54 and Week 80
measure: Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals)
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Mean of 7-point Profiles
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG)
timeFrame: Week 54 and week 80
measure: Area Under the NNC0114-0006 Concentration-time Curve Over a Dosing Interval at Steady State (AUCtau, NNC0114-0006)
timeFrame: Pre-dose and 1 hour post-dose during week 48 to week 54
measure: Terminal Half-life (t½) After Last Dose of NNC0114-0006
timeFrame: Pre-dose and 1 hour post-dose during week 48 to week 80
measure: Apparent Volume of Distribution of NNC0114-0006 at Steadystate (Vss, NNC0114-0006)
timeFrame: Pre-dose and 1 hour post-dose during week 48 to week 80
measure: Clearance of NNC0114-0006 at Steady State (CLss, NNC0114-0006)
timeFrame: Pre-dose and 1 hour post-dose during week 48 to week 54
measure: Mean Residence Time of NNC0114-0006 (MRT, NNC0114-0006)
timeFrame: Pre-dose and 1 hour post-dose during week 48 to week 80
measure: Accumulation Ratio of NNC114-0006 (RA,AUC, NNC0114-0006)
timeFrame: Pre-dose and 1 hour post-dose during (week 0 to week 6) and (week 48 to week 54)
measure: Observed NNC0114-0006 Concentration Prior to Dosing of NNC0114-0006 at Steady State (Ctrough, NNC0114-0006)
timeFrame: Week 48 (predose)
measure: Observed NNC0114-0006 Concentration 1 Hour After Dosing of NNC0114-0006 at Steady State (C1h, NNC0114-0006)
timeFrame: Week 48 (1 hour post-dose)
measure: Liraglutide Concentration at Steady State (C Liraglutide)
timeFrame: Week 54 (post-dose)
measure: Change in Biomarker: Immune Phenotyping- B Cell Panel
timeFrame: Week 0, week 54 and week 80
measure: Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel
timeFrame: Week 0, week 54 and week 80
measure: Change in Biomarker: Immune Phenotyping- T Cell Panel
timeFrame: Week 0, week 54 and week 80
measure: Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel
timeFrame: Week 0, week 54 and week 80
measure: Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel
timeFrame: Week 0, week 54 and week 80
measure: Autoantibodies Against Glutamic Acid Decarboxylase (GAD)
timeFrame: Week 0, week 54 and week 80
measure: Autoantibodies Against Zinc-transporter 8 (ZnT8)
timeFrame: Week 0, week 54 and week 80
measure: Autoantibodies Against Islet Antigen-2 (IA2)
timeFrame: Week 0, week 54 and week 80
measure: Autoantibodies Against Insulin Autoantibodies (IAA)
timeFrame: Week 0, week 54 and week 80
measure: Change in Biomarker: Total Interleukin-21 (IL-21)
timeFrame: Week 0, week 54 and week 80
measure: Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol)
timeFrame: Week 0, week 54 and week 80
measure: Change in Short Form 36 Health Survey (SF-36)
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Experience of Treatment Benefits and Barriers (ETBB)
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)
timeFrame: (Week 0, week 54) and (week 0, week 80)
measure: Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 80 Relative to Baseline
timeFrame: 0 - 4 hours post-dose on week 0 and week 80
measure: AUC0-2h of C-peptide at Week 80 Relative to Baseline
timeFrame: 0-2 hours post-dose on week 0 and week 80
measure: Cmax of C-peptide at Week 80 Relative to Baseline
timeFrame: 0-4 hours post-dose on week 0 and week 80
measure: AUC0-4h of Glucose at Week 80 Relative to Baseline
timeFrame: 0 - 4 hours post-dose on week 0 and week 80
measure: AUC0-2h of Glucose at Week 80 Relative to Baseline
timeFrame: 0-2 hours post-dose on week 0 and week 80
measure: Cmax of Glucose at Week 80 Relative to Baseline
timeFrame: 0-4 hours post-dose on week 0 and week 80
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Northridge
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Aurora
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Orlando
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Lexington
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Las Vegas
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Teaneck
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Chapel Hill
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Nashville
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Mesquite
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
city: Innsbruck
country: Austria
facility: Novo Nordisk Investigational Site
city: Salzburg
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Brussel
country: Belgium
facility: Novo Nordisk Investigational Site
city: Edegem
country: Belgium
facility: Novo Nordisk Investigational Site
city: Leuven
country: Belgium
facility: Novo Nordisk Investigational Site
city: Edmonton
country: Canada
facility: Novo Nordisk Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: Novo Nordisk Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Novo Nordisk Investigational Site
state: Manitoba
city: Halifax
country: Canada
facility: Novo Nordisk Investigational Site
state: Nova Scotia
city: Kingston
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Laval
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: PQ
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Aarhus N
country: Denmark
facility: Novo Nordisk Investigational Site
city: Esbjerg
country: Denmark
facility: Novo Nordisk Investigational Site
city: Hellerup
country: Denmark
facility: Novo Nordisk Investigational Site
city: Helsinki
country: Finland
facility: Novo Nordisk Investigational Site
city: Oulu
country: Finland
facility: Novo Nordisk Investigational Site
city: Tampere
country: Finland
facility: Novo Nordisk Investigational Site
city: Dublin
country: Ireland
facility: Novo Nordisk Investigational Site
city: Dublin
country: Ireland
facility: Novo Nordisk Investigational Site
city: Galway
country: Ireland
facility: Novo Nordisk Investigational Site
city: Holon
country: Israel
facility: Novo Nordisk Investigational Site
city: Jerusalem
country: Israel
facility: Novo Nordisk Investigational Site
city: Petah Tikva
country: Israel
facility: Novo Nordisk Investigational Site
city: Rehovot
country: Israel
facility: Novo Nordisk Investigational Site
city: Bergamo
country: Italy
facility: Novo Nordisk Investigational Site
city: Catanzaro
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: Siena
country: Italy
facility: Novo Nordisk Investigational Site
city: Oslo
country: Norway
facility: Novo Nordisk Investigational Site
city: Stavanger
country: Norway
facility: Novo Nordisk Investigational Site
city: Gdansk
country: Poland
facility: Novo Nordisk Investigational Site
city: Gdansk
country: Poland
facility: Novo Nordisk Investigational Site
city: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
city: Zabrze
country: Poland
facility: Novo Nordisk Investigational Site
city: Almada
country: Portugal
facility: Novo Nordisk Investigational Site
city: Amadora
country: Portugal
facility: Novo Nordisk Investigational Site
city: Braga
country: Portugal
facility: Novo Nordisk Investigational Site
city: Matosinhos
country: Portugal
facility: Novo Nordisk Investigational Site
city: Porto
country: Portugal
facility: Novo Nordisk Investigational Site
city: Viana do Castelo
country: Portugal
facility: Novo Nordisk Investigational Site
city: Arkhangelsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Chelyabinsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Dzerzhinskiy
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Kazan
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Penza
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saratov
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saratov
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Syktyvkar
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Ulianovsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Yoshkar-Ola
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Belgrade
country: Serbia
facility: Novo Nordisk Investigational Site
city: Kragujevac
country: Serbia
facility: Novo Nordisk Investigational Site
city: Barcelona
country: Spain
facility: Novo Nordisk Investigational Site
city: Girona
country: Spain
facility: Novo Nordisk Investigational Site
city: Málaga
country: Spain
facility: Novo Nordisk Investigational Site
city: Palma de Mallorca
country: Spain
facility: Novo Nordisk Investigational Site
city: Sabadell
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Valencia
country: Spain
facility: Novo Nordisk Investigational Site
city: Göteborg
country: Sweden
facility: Novo Nordisk Investigational Site
city: Karlstad
country: Sweden
facility: Novo Nordisk Investigational Site
city: Lund
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Kyiv
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Kyiv
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Kyiv
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Kyiv
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Kyiv
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Vinnytsia
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Zhytomyr
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Belfast
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Blackburn
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bristol
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Cardiff
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Chester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Edgbaston, Birmingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Newcastle upon Tyne
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Plymouth
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sheffield
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Stevenage
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Swansea
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: von Herrath M, Bain SC, Bode B, Clausen JO, Coppieters K, Gaysina L, Gumprecht J, Hansen TK, Mathieu C, Morales C, Mosenzon O, Segel S, Tsoukas G, Pieber TR; Anti-IL-21-liraglutide Study Group investigators and contributors. Anti-interleukin-21 antibody and liraglutide for the preservation of beta-cell function in adults with recent-onset type 1 diabetes: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Diabetes Endocrinol. 2021 Apr;9(4):212-224. doi: 10.1016/S2213-8587(21)00019-X. Epub 2021 Mar 1.