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NNC0114-0006

Phase 2

Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Apr 9, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment308

FDA Designations

No designations recorded

Clinical trial landscape

NNC0114-0006 · 4 trials · 5 indications

Phase 2 3Phase 1 1
NCT02443155A 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 FunctionDiabetes
COMPLETED308 Analytics
NCT01751152A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy and Safety of NNC0114-0006 in Subjects With Active Crohn's DiseaseInflammation
COMPLETED53 Analytics
NCT01647451A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid ArthritisInflammation
COMPLETED62 Analytics
PHASE2COMPLETED
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
DiabetesUnlock trial analytics
PHASE2COMPLETED
A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy and Safety of NNC0114-0006 in Subjects With Active Crohn's Disease
InflammationUnlock trial analytics
PHASE2COMPLETED
A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis
InflammationUnlock trial analytics

Study Endpoints

Primary Endpoints

Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline
0 - 4 hours post-dose on week 0 and week 54

Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles\*hour per liter (nmol\*h/L).

Change in Crohn's disease activity index (CDAI)
Week 0, week 4
Change in disease activity score based on 28 joints and c-reactive protein (DAS28-CRP)
Week 0, week 12
Incidence of adverse events (AEs)
From first administration of trial product (week 1) and up until week 27

Secondary Endpoints

AUC0-2h of C-peptide at Week 54 Relative to Baseline
0-2 hours post-dose on week 0 and week 54
Cmax of C-peptide at Week 54 Relative to Baseline
0-4 hours post-dose on week 0 and week 54
AUC0-4h of Glucose at Week 54 Relative to Baseline
0 - 4 hours post-dose on week 0 and week 54
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC0114-0006 + LiraglutideEXPERIMENTAL -
NNC0114-0006 + PlaceboEXPERIMENTAL -
Liraglutide + PlaceboACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
NNC0114-0006EXPERIMENTAL -
ActiveEXPERIMENTAL -

Interventions

NameTypeDescription
NNC0114-0006DRUGNNC0114-0006 12 mg/kg administered i.v (intravenously) every 6 weeks. Subjects will continue their pre-trial insulin treatment
liraglutideDRUGLiraglutide 1.8 mg administered s.c. (subcutaneously) daily. Subjects will continue their pre-trial insulin treatment
placeboDRUGPlacebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersNo
Study Sites108

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...

Countries:United StatesAustriaBelgiumCanadaDenmarkFinlandIrelandIsraelItalyNorwayPolandPortugalRussiaSerbiaSpainSwedenUkraineUnited KingdomBulgariaCzechiaSlovakiaHungaryLatviaGermany
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Competitive Landscape -Diabetes Complications 6 trials (matched to "Diabetes")

Frequently asked questions about NNC0114-0006

What is NNC0114-0006 used for?

NNC0114-0006 is an investigational small molecule being developed by Novo Nordisk for inflammatory conditions and diabetes. It has been studied in clinical trials for rheumatoid arthritis, Crohn's disease, and type 1 diabetes mellitus. The drug is not approved and remains in clinical development.

Who makes NNC0114-0006?

NNC0114-0006 is developed by Novo Nordisk A/S, a pharmaceutical company traded on the New York Stock Exchange under the ticker NVO. The company has sponsored multiple clinical trials evaluating the drug across inflammatory and metabolic indications.

What phase is NNC0114-0006 in?

NNC0114-0006 has completed Phase 2 clinical trials. It has been evaluated in randomized, double-blind, placebo-controlled studies for rheumatoid arthritis, Crohn's disease, and type 1 diabetes. The drug is investigational and not yet approved by regulatory authorities.

What clinical trials has NNC0114-0006 been in?

NNC0114-0006 has been studied in several completed trials. NCT01565408 was a Phase 1 dose-escalation study in rheumatoid arthritis. NCT01647451 was a Phase 2 efficacy trial in active rheumatoid arthritis. NCT01751152 was a Phase 2 trial in Crohn's disease. NCT02443155 was a Phase 2 proof-of-principle trial in newly diagnosed type 1 diabetes.

Has NNC0114-0006 been studied in type 1 diabetes?

Yes, NNC0114-0006 was evaluated in a Phase 2 clinical trial (NCT02443155) in adults with newly diagnosed type 1 diabetes mellitus. The trial investigated the effect of NNC0114-0006 and liraglutide on preservation of beta-cell function. The study enrolled 308 participants across multiple countries.

Is NNC0114-0006 being studied in Crohn's disease?

Yes, NNC0114-0006 was studied in a Phase 2 clinical trial (NCT01751152) for active Crohn's disease. The trial was randomized, double-blind, and placebo-controlled, enrolling 53 participants in the United States and several European countries. The study has been completed.