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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 currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Novo Nordisk A/S
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01541215
First received: February 23, 2012
Last updated: April 10, 2017
Last verified: April 2017
  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: 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: June 29, 2020
Estimated Primary Completion Date: June 29, 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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541215

Contacts
Contact: Novo Nordisk clinicaltrials@novonordisk.com

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Investigational Site Completed
Birmingham, Alabama, United States, 35233
United States, Arizona
Novo Nordisk Investigational Site Completed
Phoenix, Arizona, United States, 85053
Novo Nordisk Investigational Site Suspended
Tucson, Arizona, United States, 85724-0001
United States, California
Novo Nordisk Investigational Site Suspended
Corona, California, United States, 92880
Novo Nordisk Investigational Site Suspended
Costa Mesa, California, United States, 92626
Novo Nordisk Investigational Site Completed
Long Beach, California, United States, 90806
Novo Nordisk Investigational Site Active, not recruiting
Los Angeles, California, United States, 90027
Novo Nordisk Investigational Site Suspended
Los Angeles, California, United States, 90048-1869
Novo Nordisk Investigational Site Recruiting
Moreno Valley, California, United States, 92555
Novo Nordisk Investigational Site Completed
Palo Alto, California, United States, 94304-1503
Novo Nordisk Investigational Site Not yet recruiting
San Diego, California, United States, 92123
Novo Nordisk Investigational Site Active, not recruiting
Ventura, California, United States, 93003
United States, Connecticut
Novo Nordisk Investigational Site Completed
New Haven, Connecticut, United States, 06511
United States, Delaware
Novo Nordisk Investigational Site Suspended
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Novo Nordisk Investigational Site Completed
Washington, District of Columbia, United States, 20011
United States, Florida
Novo Nordisk Investigational Site Suspended
Jacksonville, Florida, United States, 32256
Novo Nordisk Investigational Site Suspended
Melbourne, Florida, United States, 32901
Novo Nordisk Investigational Site Suspended
Miami, Florida, United States, 33126
Novo Nordisk Investigational Site Suspended
Miami, Florida, United States, 33144
Novo Nordisk Investigational Site Completed
Miami, Florida, United States, 33155
Novo Nordisk Investigational Site Suspended
St. Petersburg, Florida, United States, 33701
Novo Nordisk Investigational Site Completed
Tallahassee, Florida, United States, 32308
Novo Nordisk Investigational Site Completed
Tampa, Florida, United States, 33612
United States, Georgia
Novo Nordisk Investigational Site Completed
Atlanta, Georgia, United States, 30318
Novo Nordisk Investigational Site Suspended
Atlanta, Georgia, United States, 30322
Novo Nordisk Investigational Site Completed
Columbus, Georgia, United States, 31904
United States, Indiana
Novo Nordisk Investigational Site Suspended
Bloomington, Indiana, United States, 47401
United States, Iowa
Novo Nordisk Investigational Site Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
Novo Nordisk Investigational Site Suspended
Topeka, Kansas, United States, 66606
United States, Kentucky
Novo Nordisk Investigational Site Suspended
Lexington, Kentucky, United States, 40503
Novo Nordisk Investigational Site Not yet recruiting
Lexington, Kentucky, United States, 40536-0284
United States, Maryland
Novo Nordisk Investigational Site Suspended
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
Novo Nordisk Investigational Site Completed
Worcester, Massachusetts, United States, 01655
United States, Michigan
Novo Nordisk Investigational Site Suspended
Detroit, Michigan, United States, 48201
Novo Nordisk Investigational Site Not yet recruiting
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Novo Nordisk Investigational Site Suspended
St. Paul, Minnesota, United States, 55102
United States, Missouri
Novo Nordisk Investigational Site Suspended
Columbia, Missouri, United States, 65201
Novo Nordisk Investigational Site Suspended
Kansas City, Missouri, United States, 64111
Novo Nordisk Investigational Site Active, not recruiting
St. Louis, Missouri, United States, 63104
United States, Nevada
Novo Nordisk Investigational Site Completed
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Novo Nordisk Investigational Site Not yet recruiting
Hackensack, New Jersey, United States, 07601
Novo Nordisk Investigational Site Suspended
West Orange, New Jersey, United States, 07052
United States, New York
Novo Nordisk Investigational Site Active, not recruiting
Buffalo, New York, United States, 14222
Novo Nordisk Investigational Site Suspended
New York, New York, United States, 10003
Novo Nordisk Investigational Site Suspended
New York, New York, United States, 10016
Novo Nordisk Investigational Site Not yet recruiting
New York, New York, United States, 10029
Novo Nordisk Investigational Site Suspended
Sleepy Hollow, New York, United States, 10591
United States, Ohio
Novo Nordisk Investigational Site Completed
Cincinnati, Ohio, United States, 45229
Novo Nordisk Investigational Site Completed
Toledo, Ohio, United States, 43606
United States, Pennsylvania
Novo Nordisk Investigational Site Recruiting
Hershey, Pennsylvania, United States, 17033
Novo Nordisk Investigational Site Completed
Philadelphia, Pennsylvania, United States, 19104
Novo Nordisk Investigational Site Suspended
Philadelphia, Pennsylvania, United States, 19134
Novo Nordisk Investigational Site Completed
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Novo Nordisk Investigational Site Active, not recruiting
Greenville, South Carolina, United States, 29615
United States, South Dakota
Novo Nordisk Investigational Site Active, not recruiting
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Novo Nordisk Investigational Site Suspended
Chattanooga, Tennessee, United States, 37403
Novo Nordisk Investigational Site Suspended
Memphis, Tennessee, United States, 38105
Novo Nordisk Investigational Site Suspended
Memphis, Tennessee, United States, 38119-3821
Novo Nordisk Investigational Site Active, not recruiting
Memphis, Tennessee, United States, 38119
Novo Nordisk Investigational Site Active, not recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Novo Nordisk Investigational Site Active, not recruiting
Amarillo, Texas, United States, 79106
Novo Nordisk Investigational Site Completed
Dallas, Texas, United States, 75235
Novo Nordisk Investigational Site Completed
Edinburg, Texas, United States, 78539
Novo Nordisk Investigational Site Completed
Fort Worth, Texas, United States, 76104
Novo Nordisk Investigational Site Suspended
Houston, Texas, United States, 77061
Novo Nordisk Investigational Site Recruiting
Kerrville, Texas, United States, 78028
Novo Nordisk Investigational Site Active, not recruiting
San Antonio, Texas, United States, 78207
Novo Nordisk Investigational Site Active, not recruiting
Schertz, Texas, United States, 78154
United States, Virginia
Novo Nordisk Investigational Site Not yet recruiting
Charlottesville, Virginia, United States, 22908
Novo Nordisk Investigational Site Not yet recruiting
Norfolk, Virginia, United States, 23507
United States, West Virginia
Novo Nordisk Investigational Site Suspended
Charleston, West Virginia, United States, 25302
Australia, Queensland
Novo Nordisk Investigational Site Completed
Ipswich, Queensland, Australia, 4305
Austria
Novo Nordisk Investigational Site Suspended
Graz, Austria, 8036
Novo Nordisk Investigational Site Suspended
Innsbruck, Austria, 6020
Novo Nordisk Investigational Site Active, not recruiting
Salzburg, Austria, 5020
Novo Nordisk Investigational Site Suspended
Wels, Austria, 4600
Belgium
Novo Nordisk Investigational Site Completed
Brussels, Belgium, 1090
Novo Nordisk Investigational Site Active, not recruiting
Brussels, Belgium, 1200
Novo Nordisk Investigational Site Completed
Leuven, Belgium, 3000
Brazil
Novo Nordisk Investigational Site Suspended
Porto Alegre, Rio Grande do Sul, Brazil, 91350-250
Canada, Alberta
Novo Nordisk Investigational Site Suspended
Edmonton, Alberta, Canada, T5X 3N5
Canada, Manitoba
Novo Nordisk Investigational Site Active, not recruiting
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
Novo Nordisk Investigational Site Suspended
Brampton, Ontario, Canada, L6T 0G1
Canada, Quebec
Novo Nordisk Investigational Site Suspended
Westmount, Quebec, Canada, H3Z 1E5
Croatia
Novo Nordisk Investigational Site Suspended
Rijeka, Croatia, 51000
Novo Nordisk Investigational Site Suspended
Zagreb, Croatia, 10 000
Denmark
Novo Nordisk Investigational Site Suspended
Herlev, Denmark, 2730
Novo Nordisk Investigational Site Suspended
Næstved, Denmark, 4700
Egypt
Novo Nordisk Investigational Site Not yet recruiting
Alexandria, Egypt, 21131
Novo Nordisk Investigational Site Not yet recruiting
Cairo, Egypt, 11562
Novo Nordisk Investigational Site Not yet recruiting
Cairo, Egypt, 11628
Novo Nordisk Investigational Site Not yet recruiting
Mansoura, Egypt, 35516
France
Novo Nordisk Investigational Site Not yet recruiting
Marseille, France, 13006
Novo Nordisk Investigational Site Not yet recruiting
MONTPELLIER cedex 05, France, 34295
Germany
Novo Nordisk Investigational Site Suspended
Ludwigshafen, Germany, 67059
Novo Nordisk Investigational Site Suspended
Mayen, Germany, 56727
Greece
Novo Nordisk Investigational Site Suspended
Athens, Greece, 151 23
Novo Nordisk Investigational Site Suspended
Athens, Greece, GR-17562
Novo Nordisk Investigational Site Suspended
Goudi/ Athens, Greece, GR-11527
Novo Nordisk Investigational Site Suspended
Thessaloniki, Greece, GR-54643
Hungary
Novo Nordisk Investigational Site Active, not recruiting
Budapest, Hungary, 1023
Novo Nordisk Investigational Site Suspended
Budapest, Hungary, 1089
Novo Nordisk Investigational Site Suspended
Budapest, Hungary, 1094
Novo Nordisk Investigational Site Suspended
Miskolc, Hungary, 3501
Novo Nordisk Investigational Site Completed
Szombathely, Hungary, H-9700
India
Novo Nordisk Investigational Site Completed
Guntur, Andhra Pradesh, India, 522001
Novo Nordisk Investigational Site Active, not recruiting
Hyderabad, Andhra Pradesh, India, 500072
Novo Nordisk Investigational Site Suspended
Hyderbad, Andhra Pradesh, India, 500 012
Novo Nordisk Investigational Site Suspended
Bangalore, Karnataka, India, 560 017
Novo Nordisk Investigational Site Suspended
Bangalore, Karnataka, India, 560041
Novo Nordisk Investigational Site Suspended
Bangalore, Karnataka, India, 560052
Novo Nordisk Investigational Site Suspended
Bangalore, Karnataka, India, 560054
Novo Nordisk Investigational Site Suspended
Mumbai, Maharashtra, India, 400008
Novo Nordisk Investigational Site Suspended
Mumbai, Maharashtra, India, 400703
Novo Nordisk Investigational Site Suspended
Pune, Maharashtra, India, 411001
Novo Nordisk Investigational Site Active, not recruiting
New Dehli, New Delhi, India, 110029
Novo Nordisk Investigational Site Suspended
Chandigarh, Punjab, India, 160012
Novo Nordisk Investigational Site Suspended
Ludhiana, Punjab, India, 141001
Novo Nordisk Investigational Site Suspended
Jaipur, Rajasthan, India, 302006
Novo Nordisk Investigational Site Active, not recruiting
Chennai, Tamil Nadu, India, 600086
Novo Nordisk Investigational Site Completed
Kolkata, West Bengal, India, 700020
Novo Nordisk Investigational Site Suspended
Kolkata, India, 700017
Israel
Novo Nordisk Investigational Site Active, not recruiting
Beer Sheva, Israel, 84101
Novo Nordisk Investigational Site Active, not recruiting
Haifa, Israel, 31096
Novo Nordisk Investigational Site Completed
Jerusalem, Israel, 91240
Novo Nordisk Investigational Site Suspended
Petah Tikva, Israel, 49202
Novo Nordisk Investigational Site Active, not recruiting
Tel Hashomer, Israel, 52621
Italy
Novo Nordisk Investigational Site Suspended
Roma, Italy, 00165
Lebanon
Novo Nordisk Investigational Site Active, not recruiting
Hazmieh, Lebanon, 9615
Novo Nordisk Investigational Site Suspended
Lebanon - Beirut, Lebanon, 9611
Macedonia, The Former Yugoslav Republic of
Novo Nordisk Investigational Site Completed
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Malaysia
Novo Nordisk Investigational Site Active, not recruiting
Kuala Lumpur, Malaysia, 59100
Mexico
Novo Nordisk Investigational Site Suspended
Tampico, Tamaulipas, Mexico, 89170
Novo Nordisk Investigational Site Active, not recruiting
Puebla, Mexico, 72190
Morocco
Novo Nordisk Investigational Site Not yet recruiting
Fès, Morocco, 30000
Novo Nordisk Investigational Site Active, not recruiting
Rabat, Morocco, 10000
Netherlands
Novo Nordisk Investigational Site Suspended
Den Bosch, Netherlands, 5223GZ
New Zealand
Novo Nordisk Investigational Site Active, not recruiting
Grafton, New Zealand, 1142
Norway
Novo Nordisk Investigational Site Suspended
Bergen, Norway, 5021
Poland
Novo Nordisk Investigational Site Suspended
Katowice, Poland, 40-752
Novo Nordisk Investigational Site Active, not recruiting
Warszawa, Poland, 04-730
Novo Nordisk Investigational Site Suspended
Wroclaw, Poland, 50-311
Portugal
Novo Nordisk Investigational Site Suspended
Braga, Portugal, 4710-243
Novo Nordisk Investigational Site Active, not recruiting
Lisboa, Portugal, 1169-045
Novo Nordisk Investigational Site Completed
Lisboa, Portugal, 1649-035
Puerto Rico
Novo Nordisk Investigational Site Completed
Ponce, Puerto Rico, 00717
Romania
Novo Nordisk Investigational Site Suspended
Timisoara, Timis, Romania, 300011
Novo Nordisk Investigational Site Suspended
Bucharest, Romania, 020614
Novo Nordisk Investigational Site Completed
Bucharest, Romania, 041451
Novo Nordisk Investigational Site Completed
Constanta, Romania, 900591
Russian Federation
Novo Nordisk Investigational Site Suspended
Chelyabinsk, Russian Federation, 454087
Novo Nordisk Investigational Site Active, not recruiting
Izhevsk, Russian Federation, 426009
Novo Nordisk Investigational Site Suspended
Krasnoyarsk, Russian Federation, 660022
Novo Nordisk Investigational Site Active, not recruiting
Moscow, Russian Federation, 117036
Novo Nordisk Investigational Site Recruiting
Moscow, Russian Federation, 125373
Novo Nordisk Investigational Site Active, not recruiting
Novosibirsk, Russian Federation, 630048
Novo Nordisk Investigational Site Completed
Saint-Petersburg, Russian Federation, 191144
Novo Nordisk Investigational Site Completed
Saint-Petersburg, Russian Federation, 194100
Novo Nordisk Investigational Site Completed
Saratov, Russian Federation, 410054
Novo Nordisk Investigational Site Completed
Tomsk, Russian Federation, 634034
Serbia
Novo Nordisk Investigational Site Suspended
Belgrade, Serbia, 11000
Novo Nordisk Investigational Site Completed
Belgrade, Serbia, 11070
Novo Nordisk Investigational Site Completed
Nis, Serbia, 18 000
Novo Nordisk Investigational Site Suspended
Nis, Serbia, 18 000
Novo Nordisk Investigational Site Suspended
Novi Sad, Serbia, 21000
Spain
Novo Nordisk Investigational Site Suspended
Leganés, Spain, 28911
Novo Nordisk Investigational Site Suspended
Madrid, Spain, 28009
Novo Nordisk Investigational Site Suspended
Madrid, Spain, 28046
Novo Nordisk Investigational Site Completed
Vitoria, Spain, 01009
Sweden
Novo Nordisk Investigational Site Suspended
Göteborg, Sweden, 416 85
Novo Nordisk Investigational Site Completed
Huddinge, Sweden, 141 57
Novo Nordisk Investigational Site Suspended
Uppsala, Sweden, 751 85
Taiwan
Novo Nordisk Investigational Site Active, not recruiting
Tainan city, Taiwan, 710
Novo Nordisk Investigational Site Active, not recruiting
Taoyuan, Taiwan, 333
Thailand
Novo Nordisk Investigational Site Active, not recruiting
Bangkok, Thailand, 10700
Novo Nordisk Investigational Site Suspended
Chiang Mai, Thailand, 50200
Turkey
Novo Nordisk Investigational Site Recruiting
Ankara, Turkey, 06100
Novo Nordisk Investigational Site Suspended
Ankara, Turkey
Novo Nordisk Investigational Site Active, not recruiting
Istanbul, Turkey, 34890
Novo Nordisk Investigational Site Completed
Kocaeli, Turkey, 41380
United Kingdom
Novo Nordisk Investigational Site Completed
Birmingham, United Kingdom, B4 6NH
Novo Nordisk Investigational Site Suspended
London, United Kingdom, SE5 9RS
Novo Nordisk Investigational Site Not yet recruiting
Manchester, United Kingdom, M13 9WL
Novo Nordisk Investigational Site Suspended
Norwich, United Kingdom, NR4 7TJ
Novo Nordisk Investigational Site Suspended
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) )
Study First Received: February 23, 2012
Last Updated: April 10, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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

ClinicalTrials.gov processed this record on April 28, 2017