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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

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ClinicalTrials.gov Identifier: NCT02443155
Recruitment Status : Active, not recruiting
First Posted : May 13, 2015
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: NNC0114-0006 Drug: liraglutide Drug: placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 10, 2015
Estimated Primary Completion Date : November 27, 2018
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Liraglutide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: NNC0114-0006 + Liraglutide Drug: NNC0114-0006
NNC0114-0006 12 mg/kg administered i.v (intravenously) every 6 weeks. Subjects will continue their pre-trial insulin treatment
Drug: liraglutide
Liraglutide 1.8 mg administered s.c. (subcutaneously) daily. Subjects will continue their pre-trial insulin treatment
Experimental: NNC0114-0006 + Placebo Drug: NNC0114-0006
NNC0114-0006 12 mg/kg administered i.v (intravenously) every 6 weeks. Subjects will continue their pre-trial insulin treatment
Drug: placebo
Placebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment
Active Comparator: Liraglutide + Placebo Drug: liraglutide
Liraglutide 1.8 mg administered s.c. (subcutaneously) daily. Subjects will continue their pre-trial insulin treatment
Drug: placebo
Placebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment
Placebo Comparator: Placebo Drug: placebo
Placebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment


Outcome Measures

Primary Outcome Measures :
  1. Area under the curve (AUC)0-4h mixed meal tolerance test(MMTT) stimulated C-peptide concentration-time curve [ Time Frame: Day 0 to week 54 ]

Secondary Outcome Measures :
  1. Number of treatment emergent episodes of diabetic ketoacidosis (DKA) [ Time Frame: Weeks 0-54 ]
  2. Number of treatment emergent hypoglycaemic episodes according to the American Diabetes Association (ADA) and Novo Nordisk definitions [ Time Frame: Weeks 0-54 ]
  3. Area under the curve 0-4h for MMTT (mixed meal tolerance test) stimulated C-peptide concentration time curve [ Time Frame: Week 0, Week 80 ]
  4. Area under the curve 0-2h for MMTT stimulated C-peptide concentration time curve [ Time Frame: Week 0, Week 54 ]
  5. Area under the curve 0-2h for MMTT stimulated C-peptide concentration time curve [ Time Frame: Week 0, Week 80 ]
  6. Maximum MMTT stimulated C-peptide concentration (Cmax, C-peptide) [ Time Frame: Week 0, Week 54 ]
  7. Maximum MMTT stimulated C-peptide concentration (Cmax, C-peptide) [ Time Frame: Week 0, Week 80 ]
  8. Change in fasting C-peptide [ Time Frame: Week 0, Week 54 ]
  9. Change in fasting C-peptide [ Time Frame: Week 0, Week 80 ]
  10. Change in HbA1c (Glycosylated haemoglobin)) [ Time Frame: Week 0, Week 54 ]
  11. Change in HbA1c (Glycosylated haemoglobin)) [ Time Frame: Week 0, Week 80 ]
  12. Change in fasting plasma glucose [ Time Frame: Week 0, Week 54 ]
  13. Change in fasting plasma glucose [ Time Frame: Week 0, Week 80 ]
  14. Total daily insulin dose in units per kg (three day average) [ Time Frame: Week 54, Week 80 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443155


  Show 108 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02443155     History of Changes
Other Study ID Numbers: NN9828-4150
2014-001215-39 ( EudraCT Number )
U1111-1154-7172 ( Other Identifier: WHO )
REec-2015-1768 ( Registry Identifier: Spanish registry )
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists