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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

Tracking Information
First Submitted Date  ICMJE June 14, 2013
First Posted Date  ICMJE June 18, 2013
Last Update Posted Date December 12, 2018
Actual Study Start Date  ICMJE October 2013
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01879917 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 17, 2013)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Liraglutide in Newly Onset Type 1 Diabetes.
Official Title  ICMJE A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Trial of Liraglutide Treatment in Subjects With Newly Diagnosed Type 1 Diabetes.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE
  • Drug: Liraglutide
    Other Name: Victoza
  • Drug: Placebo
    Saline
Study Arms  ICMJE
  • Active Comparator: Liraglutide
    1.8 mg
    Intervention: Drug: Liraglutide
  • Placebo Comparator: Saline
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 10, 2018)
65
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2013)
80
Estimated Study Completion Date  ICMJE December 2018
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01879917
Other Study ID Numbers  ICMJE 2012-005317-39
2012-005317-39 ( EudraCT Number )
U1111-1137-3221 ( Other Identifier: WHO )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas Dejgaard, Hvidovre University Hospital
Study Sponsor  ICMJE Hvidovre University Hospital
Collaborators  ICMJE
  • Steno Diabetes Center Copenhagen
  • Hillerod Hospital, Denmark
  • Bispebjerg Hospital
  • Odense University Hospital
  • Aarhus University Hospital
  • Aalborg University Hospital
  • Hospital of South West Denmark
Investigators  ICMJE
Study Director: Sten Madsbad, Professor Hvidovre University Hospital
PRS Account Hvidovre University Hospital
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP