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The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes

NCT ID: NCT01617434

Last Updated: 2017-03-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

451 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-10-31

Brief Summary

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This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

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

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

Maximum 1.8 mg administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.

Interventions

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liraglutide

Maximum 1.8 mg administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.

Intervention Type DRUG

placebo

Placebo administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with type 2 diabetes for at least 180 days prior to screening and treated with stable basal insulin analogue dose of minimum 20 U/day with or without stable metformin equal to or above 1500 mg/day for at least 8 weeks prior to screening (defined as insulin adjustments less than 10% during the past 8 weeks as assessed by the investigator)
* HbA1c (glycosylated haemoglobin A1c) 7.0-10.0% (both inclusive)
* Body mass index (BMI) 20-45 kg/m\^2 (both inclusive)

* Impaired liver or renal function
* Uncontrolled treated or untreated hypertension (systolic blood pressure (SBP) equal to or above 180 mmHg and/or diastolic blood pressure (DBP) equal to or above 100 mmHg)
* Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial
* Known or suspected abuse of alcohol or narcotics

Exclusion Criteria

* Female of child-bearing potential who is pregnant, breast-feeding or intending to become pregnant
* Recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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

Phoenix, Arizona, United States

Site Status

Novo Nordisk Investigational Site

Anaheim, California, United States

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Fresno, California, United States

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Los Angeles, 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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Tustin, California, United States

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Ventura, California, United States

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Walnut Creek, California, United States

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Kissimmee, Florida, United States

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Gurnee, Illinois, United States

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Greenfield, Indiana, United States

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Lexington, Kentucky, United States

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Metairie, Louisiana, United States

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Rockville, Maryland, United States

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Methuen, Massachusetts, United States

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Omaha, Nebraska, United States

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Newington, New Hampshire, United States

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Greensboro, North Carolina, United States

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McMurray, Pennsylvania, United States

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Spartanburg, South Carolina, United States

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Kingsport, Tennessee, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Sugarland, Texas, United States

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Salt Lake City, Utah, United States

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Midlothian, Virginia, United States

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Richmond, Virginia, United States

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Renton, Washington, United States

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Martinsburg, West Virginia, United States

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Buenos Aires, , Argentina

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Caba, , Argentina

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Caba, , Argentina

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Córdoba, , Argentina

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Coquitlam, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Burlington, Ontario, Canada

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Hamilton, Ontario, Canada

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Hamilton, Ontario, Canada

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Mississauga, Ontario, Canada

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Ottawa, Ontario, Canada

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Smiths Falls, Ontario, Canada

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Thunder Bay, Ontario, Canada

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Toronto, Ontario, Canada

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Westmount, Quebec, Canada

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Helsinki, , Finland

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Kerava, , Finland

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Tampere, , Finland

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Turku, , Finland

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Ylitornio, , Finland

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Aschaffenburg, , Germany

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Bad Lauterberg im Harz, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Friedrichsthal, , Germany

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Gelnhausen, , Germany

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Gifhorn, , Germany

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Hohenmölsen, , Germany

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Mannheim, , Germany

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Mayen, , Germany

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Oldenburg, , Germany

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Visakhapatnam, Andhra Pradesh, India

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Rohtak, Haryana, India

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Bangalore, Karnataka, India

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Indore, Madhya Pradesh, India

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Mumbai, Maharashtra, India

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Jaipur, Rajasthan, India

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Kolkata, West Bengal, India

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Hyderabad, , India

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Kolkata, , India

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Thriruvananthapuram, , India

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Pachuca, Hidalgo, Mexico

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Mexico City, México, D.F., Mexico

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Almere Stad, , Netherlands

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Breda, , Netherlands

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Eindhoven, , Netherlands

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Groningen, , Netherlands

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Hoogeveen, , Netherlands

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Leiden, , Netherlands

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Novo Nordisk Investigational Site

Rotterdam, , Netherlands

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Novo Nordisk Investigational Site

Velp, , Netherlands

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Novo Nordisk Investigational Site

Venlo, , Netherlands

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Novo Nordisk Investigational Site

Zoetermeer, , Netherlands

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Novo Nordisk Investigational Site

Zwijndrecht, , Netherlands

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Novo Nordisk Investigational Site

Niš, , Serbia

Site Status

Countries

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United States Argentina Canada Finland Germany India Mexico Netherlands Serbia

References

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Ahmann A, Rodbard HW, Rosenstock J, Lahtela JT, de Loredo L, Tornoe K, Boopalan A, Nauck MA; NN2211-3917 Study Group. Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes: a randomized, placebo-controlled trial. Diabetes Obes Metab. 2015 Nov;17(11):1056-64. doi: 10.1111/dom.12539. Epub 2015 Sep 10.

Reference Type RESULT
PMID: 26179619 (View on PubMed)

Freemantle N, Mamdani M, Vilsboll T, Kongso JH, Kvist K, Bain SC. IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy. Diabetes Ther. 2015 Dec;6(4):573-591. doi: 10.1007/s13300-015-0142-y. Epub 2015 Nov 18.

Reference Type RESULT
PMID: 26582052 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2011-002696-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1121-9874

Identifier Type: OTHER

Identifier Source: secondary_id

NN2211-3917

Identifier Type: -

Identifier Source: org_study_id

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