The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes
NCT ID: NCT02098395
Last Updated: 2017-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
835 participants
INTERVENTIONAL
2014-05-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Liraglutide 1.8 mg + insulin
liraglutide
Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
Liraglutide 1.2 mg + insulin
liraglutide
Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
Liraglutide 0.6 mg + insulin
liraglutide
Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
Liraglutide placebo 0.3 ml + insulin
placebo
Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
Liraglutide placebo 0.2 ml + insulin
placebo
Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
Liraglutide placebo 0.1 ml + insulin
placebo
Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
Interventions
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liraglutide
Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
liraglutide
Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
liraglutide
Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
placebo
Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
placebo
Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
placebo
Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
Eligibility Criteria
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Inclusion Criteria
* Male or female, aged equal to or greater than 18 years at the time of signing informed consent
* Type 1 diabetes mellitus (as diagnosed clinically) 12 months or longer prior to Visit 1 (i.e. screening)
* Treatment with basal bolus or CSII (continuous subcutaneous insulin infusion, insulin pump) treatment 6 months or longer prior to Visit 1 (i.e. screening)
* Stable insulin treatment 3 months or longer prior to Visit 1 (i.e. screening), as judged and documented by the investigator
* HbA1c 7.0-10.0 percent (Diabetes Control and Complications Trial (DCCT)), both inclusive, by central laboratory analysis (Visit 1, screening) corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC))
Exclusion Criteria
* Use of any medication, which in the investigator's opinion could interfere with the glycaemic control (e.g. systemic corticosteroids, pramlintide (Symlin®)) 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 (Visit 1) (after resting for 5 minutes) while sitting greater than 160 mmHg for systolic or greater than 100 mmHg for diastolic (repeated measurement at Visit 2 (prior to performing the trial related activities) is allowed to exclude white-coat hypertension)
* History of acute or chronic pancreatitis
* Screening (Visit 1) calcitonin value equal to or greater than 50 ng/L
18 Years
75 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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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
Phoenix, Arizona, United States
Novo Nordisk Investigational Site
Little Rock, Arkansas, United States
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Concord, California, United States
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Escondido, California, United States
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Fresno, California, United States
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Montclair, 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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Ventura, California, United States
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Walnut Creek, California, United States
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Aurora, Colorado, United States
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Golden, Colorado, United States
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Maitland, Florida, 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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Champaign, Illinois, United States
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Chicago, Illinois, United States
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Skokie, Illinois, United States
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Council Bluffs, Iowa, United States
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Lexington, Kentucky, United States
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Rockville, Maryland, United States
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Minneapolis, Minnesota, United States
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Chesterfield, Missouri, United States
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Billings, Montana, United States
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Butte, Montana, United States
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Las Vegas, Nevada, United States
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Albany, New York, United States
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Jamaica, New York, United States
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Staten Island, New York, United States
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Chapel Hill, North Carolina, United States
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Morehead City, North Carolina, United States
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Wilmington, North Carolina, United States
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Fargo, North Dakota, United States
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Bristol, Tennessee, United States
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Chattanooga, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Round Rock, Texas, United States
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Murray, Utah, United States
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Ogden, Utah, United States
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Bennington, Vermont, United States
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Federal Way, Washington, United States
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Renton, Washington, United States
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Seattle, Washington, United States
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Graz, , Austria
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Vienna, , Austria
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Aalst, , Belgium
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Bonheiden, , Belgium
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Boussu, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Kortrijk, , Belgium
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Leuven, , Belgium
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Mouscron, , Belgium
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Sint-Niklaas, , Belgium
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Blagoevgrad, , Bulgaria
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Pazardzhik, , Bulgaria
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Plovdiv, , Bulgaria
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Razgrad, , Bulgaria
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Sofia, , Bulgaria
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Calgary, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Cornwall, Ontario, Canada
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Hamilton, Ontario, Canada
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Mississauga, Ontario, Canada
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Thornhill, Ontario, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Århus C, , Denmark
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Copenhagen, , Denmark
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Hvidovre, , Denmark
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Odense, , Denmark
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Helsinki, , Finland
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Joensuu, , Finland
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Jyväskylä, , Finland
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Oulu, , Finland
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Pori, , Finland
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Turku, , Finland
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La Rochelle, , France
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Le Creusot, , France
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Marseille, , France
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Montpellier, , France
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Paris, , France
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Pierre-Bénite, , France
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Reims, , France
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Strasbourg, , France
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Toulouse, , France
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Trinité - La Martinique, , France
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Bergamo, , Italy
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Catanzaro, , Italy
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Florence, , Italy
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Palermo, , Italy
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Roma, , Italy
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Roma, , Italy
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Sesto San Giovanni (MI), , Italy
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Siena, , Italy
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's-Hertogenbosch, , Netherlands
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Amersfoort, , Netherlands
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Apeldoorn, , Netherlands
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Eindhoven, , Netherlands
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The Hague, , Netherlands
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Utrecht, , Netherlands
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Johannesburg, Gauteng, South Africa
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Cape Town, Western Cape, South Africa
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Almería, , Spain
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Gijón, , Spain
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Segovia, , Spain
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Seville, , Spain
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Seville, , Spain
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Ängelholm, , Sweden
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Linköping, , Sweden
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Malmo, , Sweden
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Örebro, , Sweden
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Stockholm, , Sweden
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Umeå, , Sweden
Countries
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References
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Ahren B, Hirsch IB, Pieber TR, Mathieu C, Gomez-Peralta F, Hansen TK, Philotheou A, Birch S, Christiansen E, Jensen TJ, Buse JB; ADJUNCT TWO Investigators. Efficacy and Safety of Liraglutide Added to Capped Insulin Treatment in Subjects With Type 1 Diabetes: The ADJUNCT TWO Randomized Trial. Diabetes Care. 2016 Oct;39(10):1693-701. doi: 10.2337/dc16-0690. Epub 2016 Aug 4.
Hoogenhout M, Malcolm-Smith S. Theory of mind predicts severity level in autism. Autism. 2017 Feb;21(2):242-252. doi: 10.1177/1362361316636758. Epub 2016 Aug 19.
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.
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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2012-005778-74
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1138-0619
Identifier Type: OTHER
Identifier Source: secondary_id
NL47705.060.14
Identifier Type: REGISTRY
Identifier Source: secondary_id
REec-2014-0884
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN9211-4083
Identifier Type: -
Identifier Source: org_study_id
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