Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic Agent
NCT ID: NCT01511198
Last Updated: 2017-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
223 participants
INTERVENTIONAL
2001-02-28
2001-10-31
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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0.045 mg
liraglutide
Injected subcutaneously once daily
0.225 mg
liraglutide
Injected subcutaneously once daily
0.45 mg
liraglutide
Injected subcutaneously once daily
0.60 mg
liraglutide
Injected subcutaneously once daily
0.75 mg
liraglutide
Injected subcutaneously once daily
Met
metformin
1000 mg twice daily, administered orally
Interventions
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liraglutide
Injected subcutaneously once daily
metformin
1000 mg twice daily, administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treated with OHA (oral hypoglycaemic agent monotherapy for at least 3 months. Prior use of metformin is allowed
* Body Mass Index (BMI) between 27.0-42.0 kg/m\^2 (inclusive)
* HbA1c maximum 10% based on analysis from central laboratory
Exclusion Criteria
* Uncontrolled treated/untreated hypertension
* Proliferative retinopathy or known autonomic neuropathy
* Recurrent severe hypoglycemia as judged by the investigator
* Known or suspected allergy to trial product or related products
* Use of any drug (except for OHAs), which in the investigators opinion could interfere with the glucose level or body weight or any contraindication to metformin use or intolerance to metformin 1000 mg (prior to trial entry or during run-in period). Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed
* Known or suspected abuse of alcohol or narcotics
* Current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness
* TSH (thyroid stimulating hormone) below 0.2 or above 15 U/mL
* Type 1 or other specific causes of diabetes
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
Vestavia Hills, Alabama, United States
Novo Nordisk Investigational Site
Tucson, Arizona, United States
Novo Nordisk Investigational Site
Carlisle, Arkansas, United States
Novo Nordisk Investigational Site
Jonesboro, Arkansas, United States
Novo Nordisk Investigational Site
Alhambra, California, United States
Novo Nordisk Investigational Site
Mission Viejo, California, United States
Novo Nordisk Investigational Site
Walnut Creek, California, United States
Novo Nordisk Investigational Site
Trumbull, Connecticut, United States
Novo Nordisk Investigational Site
Jacksonville, Florida, United States
Novo Nordisk Investigational Site
Melbourne, Florida, United States
Novo Nordisk Investigational Site
Miami, Florida, United States
Novo Nordisk Investigational Site
Ocala, Florida, United States
Novo Nordisk Investigational Site
Pembroke Pines, Florida, United States
Novo Nordisk Investigational Site
St. Petersburg, Florida, United States
Novo Nordisk Investigational Site
Titusville, Florida, United States
Novo Nordisk Investigational Site
West Palm Beach, Florida, United States
Novo Nordisk Investigational Site
Chicago, Illinois, United States
Novo Nordisk Investigational Site
Springfield, Illinois, United States
Novo Nordisk Investigational Site
Worcester, Massachusetts, United States
Novo Nordisk Investigational Site
Duluth, Minnesota, United States
Novo Nordisk Investigational Site
St Louis, Missouri, United States
Novo Nordisk Investigational Site
St Louis, Missouri, United States
Novo Nordisk Investigational Site
North Plainfield, New Jersey, United States
Novo Nordisk Investigational Site
Charlotte, North Carolina, United States
Novo Nordisk Investigational Site
Durham, North Carolina, United States
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States
Novo Nordisk Investigational Site
Corpus Christi, Texas, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
San Antonio, Texas, United States
Novo Nordisk Investigational Site
San Antonio, Texas, United States
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States
Novo Nordisk Investigational Site
Richmond, Virginia, United States
Novo Nordisk Investigational Site
Edmonds, Washington, United States
Novo Nordisk Investigational Site
Edmonds, Washington, United States
Novo Nordisk Investigational Site
Renton, Washington, United States
Novo Nordisk Investigational Site
Tacoma, Washington, United States
Novo Nordisk Investigational Site
Charleston, West Virginia, United States
Countries
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References
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Feinglos MN, Saad MF, Pi-Sunyer FX, An B, Santiago O; Liraglutide Dose-Response Study Group. Effects of liraglutide (NN2211), a long-acting GLP-1 analogue, on glycaemic control and bodyweight in subjects with Type 2 diabetes. Diabet Med. 2005 Aug;22(8):1016-23. doi: 10.1111/j.1464-5491.2005.01567.x.
Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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NN2211-2072
Identifier Type: -
Identifier Source: org_study_id
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