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The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes

NCT ID: NCT01836523

Last Updated: 2017-03-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1398 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-06-30

Brief Summary

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This trial is conducted globally. The aim of the trial is to confirm the efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. The total trial duration per subject is approximately 58 weeks.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Liraglutide 0.6 mg + insulin

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.

Liraglutide 1.2 mg + insulin

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.

Liraglutide 1.8 mg + insulin

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.

Liraglutide placebo 0.6 mg + insulin

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.

Liraglutide placebo 1.2 mg + insulin

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.

Liraglutide placebo 1.8 mg + insulin

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.

Interventions

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liraglutide

Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.

Intervention Type DRUG

placebo

Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.

Intervention Type DRUG

liraglutide

Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.

Intervention Type DRUG

placebo

Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.

Intervention Type DRUG

liraglutide

Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.

Intervention Type DRUG

placebo

Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* \- Informed consent obtained
* \- Type 1 diabetes mellitus for 12 months or longer
* \- Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump) treatment for 6 months or longer
* \- Stable insulin treatment for the last 3 months prior to Screening, as judged and documented by the investigator
* \- HbA1c 7.0-10% (Diabetes Control and Complications Trial (DCCT)), both inclusive, (corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC))
* \- Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, complete trial related questionnaires, diaries, self-monitoring of plasma glucose, self titration of insulin and attend all scheduled visits

Exclusion Criteria

* \- Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPP-4) inhibitors
* \- Use of any medication, which in the investigator's opinion could interfere with the glycaemic control or affect the subject's safety.Premix insulin is not allowed
* \- Known proliferative retinopathy or maculopathy requiring acute treatment
* \- Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator
* \- Uncontrolled/ untreated blood pressure at screening above 160 mmHg for systolic or above 100 mmHg for diastolic
* \- History of acute or chronic pancreatitis
* \- Screening calcitonin value equal to or above 50 ng/L
* \- Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2 (MEN2)
* \- Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Little Rock, Arkansas, United States

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Concord, California, United States

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Encino, California, United States

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Escondido, California, United States

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Huntington Beach, California, United States

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La Mesa, California, United States

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Lancaster, California, United States

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Monterey, California, United States

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San Mateo, California, United States

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San Ramon, California, United States

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Walnut Creek, California, United States

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Denver, Colorado, United States

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Fort Lauderdale, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Roswell, Georgia, United States

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Savannah, Georgia, United States

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Idaho Falls, Idaho, United States

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Indianapolis, Indiana, United States

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Council Bluffs, Iowa, United States

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Iowa City, Iowa, United States

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Topeka, Kansas, United States

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Metarie, Louisiana, United States

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Baltimore, Maryland, United States

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Minneapolis, Minnesota, United States

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Chesterfield, Missouri, United States

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City of Saint Peters, Missouri, United States

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Saint Charles, Missouri, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Butte, Montana, United States

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Lawrenceville, New Jersey, United States

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Albany, New York, United States

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Mineola, New York, United States

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New York, New York, United States

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New York, New York, United States

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Staten Island, New York, United States

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Syracuse, New York, United States

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Greensboro, North Carolina, United States

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Morehead City, North Carolina, United States

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Mentor, Ohio, United States

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Pittsburgh, Pennsylvania, United States

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Upper Darby, Pennsylvania, United States

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Greer, South Carolina, United States

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Myrtle Beach, South Carolina, United States

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Summerville, South Carolina, United States

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Chattanooga, Tennessee, United States

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Chattanooga, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Amarillo, Texas, United States

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Salt Lake City, Utah, United States

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Bennington, Vermont, United States

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Milwaukee, Wisconsin, United States

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Caba, , Argentina

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Caba, , Argentina

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Capital Federal, , Argentina

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Córdoba, , Argentina

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Mendoza, , Argentina

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Morón, , Argentina

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Broadmeadow, New South Wales, Australia

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Elizabeth Vale, South Australia, Australia

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Keswick, South Australia, Australia

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Melbourne, Victoria, Australia

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Parkville, Victoria, Australia

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Arlon, , Belgium

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Edegem, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Edmonton, Alberta, Canada

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Winnipeg, Manitoba, Canada

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Barrie, Ontario, Canada

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Cambridge, Ontario, Canada

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London, Ontario, Canada

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Mississauga, Ontario, Canada

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Oakville, Ontario, Canada

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Thornhill, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Québec, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Helsinki, , Finland

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Helsinki, , Finland

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Pori, , Finland

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Seinäjoki, , Finland

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Seinäjoki, , Finland

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Tampere, , Finland

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Turku, , Finland

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Besançon, , France

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Brest, , France

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Caen, , France

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Corbeil-Essonnes, , France

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Dijon, , France

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Le Creusot, , France

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Narbonne, , France

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Paris, , France

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Pointe à Pitre, , France

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Poitiers, , France

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Saint-Herblain, , France

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Saint-Priest-en-Jarez, , France

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Vénissieux, , France

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Eisenach, , Germany

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Essen, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hohenmölsen, , Germany

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Marburg, , Germany

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Münster, , Germany

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Pohlheim, , Germany

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Rehlingen-Siersburg, , Germany

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Saint Ingbert, , Germany

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Dublin, , Ireland

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Dublin, , Ireland

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Dublin, , Ireland

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Dublin, , Ireland

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Galway, , Ireland

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Haifa, , Israel

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Holon, , Israel

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Jerusalem, , Israel

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Jerusalem, , Israel

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Petah Tikva, , Israel

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Rishon LeZiyyon, , Israel

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Amsterdam, , Netherlands

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Hoogeveen, , Netherlands

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Leiden, , Netherlands

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Nijmegen, , Netherlands

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Rotterdam, , Netherlands

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The Hague, , Netherlands

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Venlo, , Netherlands

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Bergen, , Norway

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Gjettum, , Norway

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Hamar, , Norway

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Kongsvinger, , Norway

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Stavanger, , Norway

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Lublin, , Poland

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Puławy, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Zabrze, , Poland

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Kazan', , Russia

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Kazan', , Russia

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Penza, , Russia

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Saratov, , Russia

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Volgograd, , Russia

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Gothenburg, , Sweden

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Malmo, , Sweden

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Stockholm, , Sweden

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Stockholm, , Sweden

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Kharkiv, , Ukraine

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Kharkiv, , Ukraine

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Kiev, , Ukraine

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Poltava, , Ukraine

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Zhytomyr, , Ukraine

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Blackburn, , United Kingdom

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Bristol, , United Kingdom

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Durham, , United Kingdom

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Edgbaston, Birmingham, , United Kingdom

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Edinburgh, , United Kingdom

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Middlesbrough, , United Kingdom

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Plymouth, , United Kingdom

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Southall, , United Kingdom

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St Helens, , United Kingdom

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Stevenage, , United Kingdom

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Countries

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United States Argentina Australia Belgium Canada Finland France Germany Ireland Israel Netherlands Norway Poland Russia Sweden Ukraine United Kingdom

References

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Mathieu C, Zinman B, Hemmingsson JU, Woo V, Colman P, Christiansen E, Linder M, Bode B; ADJUNCT ONE Investigators. Efficacy and Safety of Liraglutide Added to Insulin Treatment in Type 1 Diabetes: The ADJUNCT ONE Treat-To-Target Randomized Trial. Diabetes Care. 2016 Oct;39(10):1702-10. doi: 10.2337/dc16-0691. Epub 2016 Aug 9.

Reference Type RESULT
PMID: 27506222 (View on PubMed)

Shah VN, Agesen RM, Bardtrum L, Christiansen E, Snaith J, Greenfield JR. Determinants of Liraglutide Treatment Discontinuation in Type 1 Diabetes: A Post Hoc Analysis of ADJUNCT ONE and ADJUNCT TWO Randomized Placebo-Controlled Clinical Studies. J Diabetes Sci Technol. 2025 Mar;19(2):321-331. doi: 10.1177/19322968241305647. Epub 2024 Dec 24.

Reference Type DERIVED
PMID: 39717993 (View on PubMed)

Dejgaard TF, von Scholten BJ, Christiansen E, Kreiner FF, Bardtrum L, von Herrath M, Mathieu C, Madsbad S; ADJUNCT ONE and ADJUNCT TWO Investigators. Efficacy and safety of liraglutide in type 1 diabetes by baseline characteristics in the ADJUNCT ONE and ADJUNCT TWO randomized controlled trials. Diabetes Obes Metab. 2021 Dec;23(12):2752-2762. doi: 10.1111/dom.14532. Epub 2021 Sep 28.

Reference Type DERIVED
PMID: 34463425 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2012-003580-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1133-0590

Identifier Type: OTHER

Identifier Source: secondary_id

NN9211-3919

Identifier Type: -

Identifier Source: org_study_id

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