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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

NCT ID: NCT02443155

Last Updated: 2021-04-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-10

Study Completion Date

2019-02-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NNC0114-0006 + Liraglutide

Group Type EXPERIMENTAL

NNC0114-0006

Intervention Type DRUG

NNC0114-0006 12 mg/kg administered i.v (intravenously) every 6 weeks. Subjects will continue their pre-trial insulin treatment

liraglutide

Intervention Type DRUG

Liraglutide 1.8 mg administered s.c. (subcutaneously) daily. Subjects will continue their pre-trial insulin treatment

NNC0114-0006 + Placebo

Group Type EXPERIMENTAL

NNC0114-0006

Intervention Type DRUG

NNC0114-0006 12 mg/kg administered i.v (intravenously) every 6 weeks. Subjects will continue their pre-trial insulin treatment

placebo

Intervention Type DRUG

Placebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment

Liraglutide + Placebo

Group Type ACTIVE_COMPARATOR

liraglutide

Intervention Type DRUG

Liraglutide 1.8 mg administered s.c. (subcutaneously) daily. Subjects will continue their pre-trial insulin treatment

placebo

Intervention Type DRUG

Placebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment

Interventions

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NNC0114-0006

NNC0114-0006 12 mg/kg administered i.v (intravenously) every 6 weeks. Subjects will continue their pre-trial insulin treatment

Intervention Type DRUG

liraglutide

Liraglutide 1.8 mg administered s.c. (subcutaneously) daily. Subjects will continue their pre-trial insulin treatment

Intervention Type DRUG

placebo

Placebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

La Jolla, California, United States

Site Status

Novo Nordisk Investigational Site

Northridge, California, United States

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Novo Nordisk Investigational Site

Aurora, Colorado, United States

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Novo Nordisk Investigational Site

Miami, Florida, United States

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Novo Nordisk Investigational Site

Orlando, Florida, United States

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Atlanta, Georgia, United States

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Lexington, Kentucky, United States

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Las Vegas, Nevada, United States

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Teaneck, New Jersey, United States

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Chapel Hill, North Carolina, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Mesquite, Texas, United States

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Graz, , Austria

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Innsbruck, , Austria

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Salzburg, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Brussels, , Belgium

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Edegem, , Belgium

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Leuven, , Belgium

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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Kingston, Ontario, Canada

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Toronto, Ontario, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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PQ, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Aarhus N, , Denmark

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Esbjerg, , Denmark

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Hellerup, , Denmark

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Helsinki, , Finland

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Oulu, , Finland

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Tampere, , Finland

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Dublin, , Ireland

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Dublin, , Ireland

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Galway, , Ireland

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Holon, , Israel

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Jerusalem, , Israel

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Petah Tikva, , Israel

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Rehovot, , Israel

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Bergamo, , Italy

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Catanzaro, , Italy

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Milan, , Italy

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Siena, , Italy

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Oslo, , Norway

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Stavanger, , Norway

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Gdansk, , Poland

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Gdansk, , Poland

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Warsaw, , Poland

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Zabrze, , Poland

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Almada, , Portugal

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Amadora, , Portugal

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Braga, , Portugal

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Matosinhos Municipality, , Portugal

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Porto, , Portugal

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Viana do Castelo, , Portugal

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Arkhangelsk, , Russia

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Chelyabinsk, , Russia

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Dzerzhinskiy, , Russia

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Kazan', , Russia

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Moscow, , Russia

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Moscow, , Russia

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Novosibirsk, , Russia

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Penza, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Saratov, , Russia

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Syktyvkar, , Russia

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Ulyanovsk, , Russia

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Yoshkar-Ola, , Russia

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Belgrade, , Serbia

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Kragujevac, , Serbia

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Barcelona, , Spain

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Girona, , Spain

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Málaga, , Spain

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Palma de Mallorca, , Spain

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Sabadell, , Spain

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Seville, , Spain

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Seville, , Spain

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Valencia, , Spain

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Gothenburg, , Sweden

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Karlstad, , Sweden

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Lund, , Sweden

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Stockholm, , Sweden

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Vinnytsia, , Ukraine

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Zhytomyr, , Ukraine

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Belfast, , United Kingdom

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Blackburn, , United Kingdom

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Bristol, , United Kingdom

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Cardiff, , United Kingdom

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Chester, , United Kingdom

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Edgbaston, Birmingham, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Plymouth, , United Kingdom

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Sheffield, , United Kingdom

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Stevenage, , United Kingdom

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Swansea, , United Kingdom

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Countries

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United States Austria Belgium Canada Denmark Finland Ireland Israel Italy Norway Poland Portugal Russia Serbia Spain Sweden Ukraine United Kingdom

References

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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.

Reference Type RESULT
PMID: 33662334 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2014-001215-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1154-7172

Identifier Type: OTHER

Identifier Source: secondary_id

REec-2015-1768

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN9828-4150

Identifier Type: -

Identifier Source: org_study_id

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