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Liraglutide in Newly Onset Type 1 Diabetes. (NewLira)

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ClinicalTrials.gov Identifier: NCT01879917
Recruitment Status : Active, not recruiting
First Posted : June 18, 2013
Last Update Posted : December 12, 2018
Sponsor:
Collaborators:
Steno Diabetes Center Copenhagen
Hillerod Hospital, Denmark
Bispebjerg Hospital
Odense University Hospital
Aarhus University Hospital
Aalborg University Hospital
Hospital of South West Denmark
Information provided by (Responsible Party):
Thomas Dejgaard, Hvidovre University Hospital

Brief Summary:
The purpose of this study is to investigate the effect and safety of liraglutide 1.8 mg once daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Liraglutide Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Trial of Liraglutide Treatment in Subjects With Newly Diagnosed Type 1 Diabetes.
Actual Study Start Date : October 2013
Actual Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Liraglutide

Arm Intervention/treatment
Active Comparator: Liraglutide
1.8 mg
Drug: Liraglutide
Other Name: Victoza

Placebo Comparator: Saline Drug: Placebo
Saline




Primary Outcome Measures :
  1. Beta-cell function [ Time Frame: 52 weeks ]
    To investigate the effect and safety of liraglutide 1.8 mg once daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment.


Secondary Outcome Measures :
  1. Postprandial glucagon [ Time Frame: 52 weeks ]
    To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change in Postprandial glucagon levels following sustacal meal test.


Other Outcome Measures:
  1. HbA1c [ Time Frame: 52 weeks ]
    To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change in: HbA1c.

  2. Insulin dose [ Time Frame: 52 weeks ]
    To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change ininsulin dose.

  3. Weight [ Time Frame: 52 weeks ]
    To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change in weight.

  4. Remission period [ Time Frame: 52 weeks ]
    To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change in length of insulin remission period.

  5. Hypoglycemia [ Time Frame: 52 weeks ]
    To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change in frequency of hypoglycaemic events.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes according to WHO criteria diagnosed ≤ 6 weeks before visit 0
  • Age 18 - 40 years - both inclusive
  • Postprandial C-peptide > 0.2 nmol/l following sustacal meal test
  • Able to understand the written patient information and to give informed consent

Exclusion Criteria:

  • Type 2 diabetes
  • Body mass index <20 kg/m2
  • Pregnancy or unwillingness to use safe contraceptives
  • Compromised kidney function (eGFR < 60 ml/min/1,73m2), dialysis or kidney transplantation at visit 0
  • Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal at visit 0

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): NCT01879917


Locations
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Denmark
Dep. of Endocrinology, Hvidovre University Hospital
Hvidovre, Capital, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Steno Diabetes Center Copenhagen
Hillerod Hospital, Denmark
Bispebjerg Hospital
Odense University Hospital
Aarhus University Hospital
Aalborg University Hospital
Hospital of South West Denmark
Investigators
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Study Director: Sten Madsbad, Professor Hvidovre University Hospital

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Responsible Party: Thomas Dejgaard, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01879917     History of Changes
Other Study ID Numbers: 2012-005317-39
2012-005317-39 ( EudraCT Number )
U1111-1137-3221 ( Other Identifier: WHO )
First Posted: June 18, 2013    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

Keywords provided by Thomas Dejgaard, Hvidovre University Hospital:
c-peptide
insulin
hypoglycemia
Newly onset
Diabetes
Type 1
Beta cell
Autoimmune
Glucagon
Meal test

Additional relevant MeSH terms:
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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