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Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes (Ellipse™)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01541215
First Posted: February 29, 2012
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Drug: placebo Drug: metformin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 26 ]

Secondary Outcome Measures:
  • Number of subjects having HbA1c below 7.0% [ Time Frame: Week 26 ]
  • Number of subjects having HbA1c below 7.0% [ Time Frame: Week 52 ]
  • Number of subjects having HbA1c maximum 6.5% [ Time Frame: Week 26 ]
  • Number of subjects having HbA1c maximum 6.5% [ Time Frame: Week 52 ]
  • Number of subjects having HbA1c below 7.0% without severe or minor hypoglycaemic episodes [ Time Frame: Week 26 ]
  • Number of subjects having HbA1c below 7.0% without severe or minor hypoglycaemic episodes [ Time Frame: Week 52 ]
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 26 ]
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 52 ]
  • Change from baseline in 7-point self-measured plasma glucose [ Time Frame: Week 0, week 26 ]
  • Change from baseline in 7-point self-measured plasma glucose [ Time Frame: Week 0, week 52 ]
  • Change from baseline in body weight [ Time Frame: Week 0, week 26 ]
  • Change from baseline in body weight [ Time Frame: Week 0, week 52 ]
  • Change from baseline in BMI standard deviation score (SDS) [ Time Frame: Week 0, week 26 ]
  • Change from baseline in BMI standard deviation score (SDS) [ Time Frame: Week 0, week 52 ]
  • Number of adverse events (AEs) [ Time Frame: Week 26 ]
  • Number of adverse events (AEs) [ Time Frame: Week 52 ]
  • Number of adverse events (AEs) [ Time Frame: week 104 (1 year follow-up) ]
  • Number of adverse events (AEs) [ Time Frame: Week 156 (2 year follow-up) ]
  • Number of serious adverse events (SAEs) [ Time Frame: Week 26 ]
  • Number of serious adverse events (SAEs) [ Time Frame: Week 52 ]
  • Number of serious adverse events (SAEs) [ Time Frame: Week 104 (1 year follow-up) ]
  • Number of serious adverse events (SAEs) [ Time Frame: Week 156 (2 year follow-up ) ]
  • Growth velocity [ Time Frame: Week 104 (1 year follow-up) ]
  • Growth velocity [ Time Frame: Week 156 (2 year follow-up) ]
  • Pubertal progression [ Time Frame: Week 104 (1 year follow-up) ]
  • Pubertal progression [ Time Frame: Week 156 (2 year follow-up) ]

Estimated Enrollment: 150
Actual Study Start Date: November 13, 2012
Estimated Study Completion Date: May 20, 2020
Estimated Primary Completion Date: June 28, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lira + Met Drug: liraglutide
Administered subcutaneously (s.c., under the skin) once daily.1.8 mg or maximum tolerated dose (MTD: 0.6 mg, 1.2 mg, 1.8 mg) for 26 weeks. Subjects will continue treatment in a 26 week open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.
Drug: metformin
Tablets administered for 26 weeks. Maximum tolerated dose (MTD) between 1000-2000 mg at the discretion of the investigator. Subjects will continue treatment in a 26 week open-labelled extension.
Placebo Comparator: Placebo + Met Drug: placebo
Administered subcutaneously (s.c., under the skin) once daily for 26 weeks. Subjects will discontinue placebo treatment in the open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.
Drug: metformin
Tablets administered for 26 weeks. Maximum tolerated dose (MTD) between 1000-2000 mg at the discretion of the investigator. Subjects will continue treatment in a 26 week open-labelled extension.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children and adolescents between the ages of 10-16 years. Subjects cannot turn 17 years and 11 months before the end of treatment (52 weeks)
  • Diagnosis of type 2 diabetes mellitus and treated for at least 30 days with: diet and exercise alone, diet and exercise in combination with metformin monotherapy, diet and exercise in combination with metformin and a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin, diet and exercise in combination with a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin
  • HbA1c: 7.0-11% (inclusive) if diet and exercise treated or 6.5-11% (inclusive) if treated with metformin as monotherapy, basal insulin as monotherapy or metformin and basal insulin in combination
  • Body mass index (BMI) above 85% percentile of the general age and gender matched population

Exclusion Criteria:

  • Type 1 diabetes
  • Maturity onset diabetes of the young (MODY)
  • Use of any antidiabetic agent other than metformin and/or basal insulin within 90 days prior to screening
  • Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  • 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
  • Uncontrolled hypertension, treated or untreated above 99th percentile for age and gender in children
  • Known or suspected abuse of alcohol or drugs/narcotics
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01541215


  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35233
United States, Arizona
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85053
Novo Nordisk Investigational Site
Tucson, Arizona, United States, 85724-0001
United States, California
Novo Nordisk Investigational Site
Corona, California, United States, 92880
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Costa Mesa, California, United States, 92626
Novo Nordisk Investigational Site
Long Beach, California, United States, 90806
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Los Angeles, California, United States, 90027
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90048-1869
Novo Nordisk Investigational Site
Moreno Valley, California, United States, 92555
Novo Nordisk Investigational Site
Palo Alto, California, United States, 94304-1503
Novo Nordisk Investigational Site
San Diego, California, United States, 92123
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Ventura, California, United States, 93003
United States, Connecticut
Novo Nordisk Investigational Site
New Haven, Connecticut, United States, 06511
United States, Delaware
Novo Nordisk Investigational Site
Wilmington, Delaware, United States, 19803
United States, District of Columbia
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Washington, D.C., District of Columbia, United States, 20011
United States, Florida
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Jacksonville, Florida, United States, 32256
Novo Nordisk Investigational Site
Melbourne, Florida, United States, 32901
Novo Nordisk Investigational Site
Miami, Florida, United States, 33126
Novo Nordisk Investigational Site
Miami, Florida, United States, 33144
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Miami, Florida, United States, 33155
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Saint Petersburg, Florida, United States, 33701
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Tallahassee, Florida, United States, 32308
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Tampa, Florida, United States, 33612
United States, Georgia
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Atlanta, Georgia, United States, 30318
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Atlanta, Georgia, United States, 30322
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Columbus, Georgia, United States, 31904
United States, Indiana
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Bloomington, Indiana, United States, 47401
United States, Iowa
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Iowa City, Iowa, United States, 52242
United States, Kansas
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Topeka, Kansas, United States, 66606
United States, Kentucky
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Lexington, Kentucky, United States, 40503
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Lexington, Kentucky, United States, 40536-0284
United States, Maryland
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Silver Spring, Maryland, United States, 20910
United States, Massachusetts
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Worcester, Massachusetts, United States, 01655
United States, Michigan
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Detroit, Michigan, United States, 48201
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Grand Rapids, Michigan, United States, 49503
United States, Minnesota
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Saint Paul, Minnesota, United States, 55102
United States, Missouri
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Columbia, Missouri, United States, 65201
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Kansas City, Missouri, United States, 64111
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Saint Louis, Missouri, United States, 63104
United States, Nevada
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Las Vegas, Nevada, United States, 89128
United States, New Jersey
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Hackensack, New Jersey, United States, 07601
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West Orange, New Jersey, United States, 07052
United States, New York
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Buffalo, New York, United States, 14203
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New York, New York, United States, 10003
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New York, New York, United States, 10016
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New York, New York, United States, 10029
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Sleepy Hollow, New York, United States, 10591
United States, Ohio
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Cincinnati, Ohio, United States, 45229
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Toledo, Ohio, United States, 43606
United States, Pennsylvania
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Hershey, Pennsylvania, United States, 17033
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Philadelphia, Pennsylvania, United States, 19104
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Philadelphia, Pennsylvania, United States, 19134
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Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
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Greenville, South Carolina, United States, 29615
United States, South Dakota
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Rapid City, South Dakota, United States, 57701
United States, Tennessee
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Chattanooga, Tennessee, United States, 37403
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Memphis, Tennessee, United States, 38105
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Memphis, Tennessee, United States, 38119-3821
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Memphis, Tennessee, United States, 38119
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Nashville, Tennessee, United States, 37232
United States, Texas
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Amarillo, Texas, United States, 79106
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Dallas, Texas, United States, 75235
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Edinburg, Texas, United States, 78539
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Fort Worth, Texas, United States, 76104
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Houston, Texas, United States, 77061
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Kerrville, Texas, United States, 78028
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San Antonio, Texas, United States, 78207
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Schertz, Texas, United States, 78154
United States, Virginia
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Charlottesville, Virginia, United States, 22908
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Norfolk, Virginia, United States, 23507
United States, West Virginia
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Charleston, West Virginia, United States, 25302
Australia, Queensland
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Ipswich, Queensland, Australia, 4305
Austria
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Graz, Austria, 8036
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Innsbruck, Austria, 6020
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Salzburg, Austria, 5020
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Wels, Austria, 4600
Belgium
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Brussels, Belgium, 1090
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Brussels, Belgium, 1200
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Leuven, Belgium, 3000
Brazil
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Porto Alegre, Rio Grande do Sul, Brazil, 91350-250
Canada, Alberta
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Edmonton, Alberta, Canada, T5X 3N5
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
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Brampton, Ontario, Canada, L6T 0G1
Canada, Quebec
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Westmount, Quebec, Canada, H3Z 1E5
Croatia
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Rijeka, Croatia, 51000
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Zagreb, Croatia, 10 000
Denmark
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Herlev, Denmark, 2730
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Næstved, Denmark, 4700
Egypt
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Alexandria, Egypt, 21131
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Cairo, Egypt, 11562
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Cairo, Egypt, 11628
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Mansoura, Egypt, 35516
France
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Marseille, France, 13006
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MONTPELLIER cedex 05, France, 34295
Germany
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Ludwigshafen, Germany, 67059
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Mayen, Germany, 56727
Greece
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Athens, Greece, 151 23
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Athens, Greece, GR-17562
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Goudi/ Athens, Greece, GR-11527
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Thessaloniki, Greece, GR-54643
Hungary
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Budapest, Hungary, 1023
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Budapest, Hungary, 1089
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Budapest, Hungary, 1094
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Miskolc, Hungary, 3501
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Szombathely, Hungary, H-9700
India
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Guntur, Andhra Pradesh, India, 522001
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Hyderabad, Andhra Pradesh, India, 500072
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Hyderbad, Andhra Pradesh, India, 500 012
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Bangalore, Karnataka, India, 560 017
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Bangalore, Karnataka, India, 560041
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Bangalore, Karnataka, India, 560052
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Bangalore, Karnataka, India, 560054
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Mumbai, Maharashtra, India, 400008
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Mumbai, Maharashtra, India, 400703
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Pune, Maharashtra, India, 411001
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New Dehli, New Delhi, India, 110029
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Chandigarh, Punjab, India, 160012
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Ludhiana, Punjab, India, 141001
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Jaipur, Rajasthan, India, 302006
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Chennai, Tamil Nadu, India, 600086
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Kolkata, West Bengal, India, 700020
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Kolkata, India, 700017
Israel
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Beer Sheva, Israel, 84101
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Haifa, Israel, 31096
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Jerusalem, Israel, 91240
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Petah Tikva, Israel, 49202
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Tel Hashomer, Israel, 52621
Italy
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Roma, Italy, 00165
Lebanon
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Hazmieh, Lebanon, 9615
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Lebanon - Beirut, Lebanon, 9611
Macedonia, The Former Yugoslav Republic of
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Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Malaysia
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Kuala Lumpur, Malaysia, 59100
Mexico
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Tampico, Tamaulipas, Mexico, 89170
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Puebla, Mexico, 72190
Morocco
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Fès, Morocco, 30000
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Rabat, Morocco, 10000
Netherlands
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Den Bosch, Netherlands, 5223GZ
New Zealand
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Grafton, New Zealand, 1142
Norway
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Bergen, Norway, 5021
Poland
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Katowice, Poland, 40-752
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Warszawa, Poland, 04-730
Novo Nordisk Investigational Site
Wroclaw, Poland, 50-311
Portugal
Novo Nordisk Investigational Site
Braga, Portugal, 4710-243
Novo Nordisk Investigational Site
Lisboa, Portugal, 1169-045
Novo Nordisk Investigational Site
Lisboa, Portugal, 1649-035
Puerto Rico
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Ponce, Puerto Rico, 00717
Romania
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Timisoara, Timis, Romania, 300011
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Bucharest, Romania, 020614
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Bucharest, Romania, 041451
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Constanta, Romania, 900591
Russian Federation
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Chelyabinsk, Russian Federation, 454087
Novo Nordisk Investigational Site
Izhevsk, Russian Federation, 426009
Novo Nordisk Investigational Site
Krasnoyarsk, Russian Federation, 660022
Novo Nordisk Investigational Site
Moscow, Russian Federation, 117036
Novo Nordisk Investigational Site
Moscow, Russian Federation, 125373
Novo Nordisk Investigational Site
Novosibirsk, Russian Federation, 630048
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 191144
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 194100
Novo Nordisk Investigational Site
Saratov, Russian Federation, 410054
Novo Nordisk Investigational Site
Tomsk, Russian Federation, 634034
Serbia
Novo Nordisk Investigational Site
Belgrade, Serbia, 11000
Novo Nordisk Investigational Site
Belgrade, Serbia, 11070
Novo Nordisk Investigational Site
Nis, Serbia, 18 000
Novo Nordisk Investigational Site
Novi Sad, Serbia, 21000
Spain
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Leganés, Spain, 28911
Novo Nordisk Investigational Site
Madrid, Spain, 28009
Novo Nordisk Investigational Site
Madrid, Spain, 28046
Novo Nordisk Investigational Site
Vigo, Spain, 36312
Novo Nordisk Investigational Site
Vitoria, Spain, 01009
Sweden
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Göteborg, Sweden, 416 85
Novo Nordisk Investigational Site
Huddinge, Sweden, 141 57
Novo Nordisk Investigational Site
Uppsala, Sweden, 751 85
Taiwan
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Tainan city, Taiwan, 710
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Taoyuan, Taiwan, 333
Thailand
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Bangkok, Thailand, 10700
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Chiang Mai, Thailand, 50200
Turkey
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Ankara, Turkey, 06100
Novo Nordisk Investigational Site
Ankara, Turkey
Novo Nordisk Investigational Site
Istanbul, Turkey, 34890
Novo Nordisk Investigational Site
Kocaeli, Turkey, 41380
United Kingdom
Novo Nordisk Investigational Site
Birmingham, United Kingdom, B4 6NH
Novo Nordisk Investigational Site
London, United Kingdom, SE5 9RS
Novo Nordisk Investigational Site
Manchester, United Kingdom, M13 9WL
Novo Nordisk Investigational Site
Norwich, United Kingdom, NR4 7TJ
Novo Nordisk Investigational Site
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01541215     History of Changes
Other Study ID Numbers: NN2211-3659
2011-002605-29 ( EudraCT Number )
P/288/2010 ( Other Identifier: EMA (PDCO) )
U1111-1121-8743 ( Other Identifier: WHO )
CTRI/2013/10/004082 ( Registry Identifier: Clinical Trials Registry - India (CTRI) )
First Submitted: February 23, 2012
First Posted: February 29, 2012
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists