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Completed

NCT Number: NCT01879917

Liraglutide in Newly Onset Type 1 Diabetes.

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Hypoglycemia Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Dep. of Endocrinology, Hvidovre University Hospital

Hvidovre, Capital, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

Other names: Victoza

Placebo

Drug

Saline

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Bispebjerg Hospital
  • Esbjerg Hospital - University Hospital of Southern Denmark
  • Hillerod Hospital, Denmark
  • Odense University Hospital
  • Steno Diabetes Center Copenhagen

Registry information

Official study title

A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Trial of Liraglutide Treatment in Subjects With Newly Diagnosed Type 1 Diabetes.

Acronym: NewLira

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 18, 2013
Registry last updated
Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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