NCT02443155|CompletedPhase 2Results

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

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

Novo Nordisk A/S ClinicalTrials.gov

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4 other identifiers

NN9828-41502014-001215-39U1111-1154-7172REec-2015-1768

Study Type

interventional

Target

308

Locations

17 countries

Sites

106

Timeline

RegisteredMay 2015

StartedNov 2015

CompletionFeb 2019

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

308

participants targeted

Target at P75+ for phase_2 diabetes

Timeline

Completed

Started Nov 2015

Typical duration for phase_2 diabetes

Geographic Reach

17 countries

106 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.3 years study duration

First Submitted

Initial submission to the registry

May 11, 2015

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed

6 months until next milestone

Study Start

First participant enrolled

November 10, 2015

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2019

Completed

1.9 years until next milestone

Results Posted

Study results publicly available

January 11, 2021

Completed

Last Updated

April 9, 2021

Status Verified

March 1, 2021

Enrollment Period

2.8 years

First QC Date

May 11, 2015

Results QC Date

December 11, 2020

Last Update Submit

March 10, 2021

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (114)

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
AUC0-2h of Glucose at Week 54 Relative to Baseline
0-2 hours post-dose on week 0 and week 54
Cmax of Glucose at Week 54 Relative to Baseline
0-4 hours post-dose on week 0 and week 54
+109 more secondary outcomes

Study Arms (4)

NNC0114-0006 + Liraglutide

EXPERIMENTAL

Drug: NNC0114-0006Drug: liraglutide

NNC0114-0006 + Placebo

EXPERIMENTAL

Drug: NNC0114-0006Drug: placebo

Liraglutide + Placebo

ACTIVE COMPARATOR

Drug: liraglutideDrug: placebo

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

NNC0114-0006DRUG

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

NNC0114-0006 + LiraglutideNNC0114-0006 + Placebo

liraglutideDRUG

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

Liraglutide + PlaceboNNC0114-0006 + Liraglutide

placeboDRUG

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

Liraglutide + PlaceboNNC0114-0006 + PlaceboPlacebo

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

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)

You may not qualify if:

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

Contact the study team to confirm eligibility.