Comparing the Efficacy and Safety of NN1250 Once Daily When Titrated Using 2 Different Algorithms in Insulin naïve Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT01326026
Last Updated: 2017-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
222 participants
INTERVENTIONAL
2011-03-31
2011-12-31
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
NONE
Study Groups
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IDeg Simple
insulin degludec
Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
IDeg Step wise
insulin degludec
Injected subcutaneously (under the skin) once daily. Dose individually adjusted in a stepwise manner.
Interventions
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insulin degludec
Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
insulin degludec
Injected subcutaneously (under the skin) once daily. Dose individually adjusted in a stepwise manner.
Eligibility Criteria
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Inclusion Criteria
* Current treatment: metformin monotherapy or metformin in any combination with 1 or 2 other OADs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones (TZDs) all with unchanged dosing for at least 12 weeks prior to randomisation (Visit 2)-metformin: alone or in combination (including fixed combination) must be at least 1000 mg daily
* HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
* BMI (Body Mass Index) no higher than 45.0 kg/m\^2
Exclusion Criteria
* Suffer from a life threatening disease (e.g. cancer)
* Females of childbearing potential who are pregnant (as determined by central laboratory beta-human chorionic gonadotropin (beta-hCG), breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods as required by law or practise \[for Germany, adequate contraceptive methods are: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner\])
18 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
Birmingham, Alabama, United States
Novo Nordisk Investigational Site
Huntsville, Alabama, United States
Novo Nordisk Investigational Site
Anaheim, California, United States
Novo Nordisk Investigational Site
La Jolla, California, United States
Novo Nordisk Investigational Site
Mission Hills, California, United States
Novo Nordisk Investigational Site
National City, California, United States
Novo Nordisk Investigational Site
North Hollywood, California, United States
Novo Nordisk Investigational Site
San Diego, California, United States
Novo Nordisk Investigational Site
Golden, Colorado, United States
Novo Nordisk Investigational Site
Kissimmee, Florida, United States
Novo Nordisk Investigational Site
Tampa, Florida, United States
Novo Nordisk Investigational Site
Columbus, Georgia, United States
Novo Nordisk Investigational Site
Springfield, Illinois, United States
Novo Nordisk Investigational Site
Evansville, Indiana, United States
Novo Nordisk Investigational Site
Slidell, Louisiana, United States
Novo Nordisk Investigational Site
Billings, Montana, United States
Novo Nordisk Investigational Site
Staten Island, New York, United States
Novo Nordisk Investigational Site
Greensboro, North Carolina, United States
Novo Nordisk Investigational Site
Franklin, Ohio, United States
Novo Nordisk Investigational Site
Melrose Park, Pennsylvania, United States
Novo Nordisk Investigational Site
East Providence, Rhode Island, United States
Novo Nordisk Investigational Site
Humboldt, Tennessee, United States
Novo Nordisk Investigational Site
Houston, Texas, United States
Novo Nordisk Investigational Site
Killeen, Texas, United States
Novo Nordisk Investigational Site
San Antonio, Texas, United States
Novo Nordisk Investigational Site
Ogden, Utah, United States
Novo Nordisk Investigational Site
St. George, Utah, United States
Novo Nordisk Investigational Site
Helsinki, , Finland
Novo Nordisk Investigational Site
Kerava, , Finland
Novo Nordisk Investigational Site
Tampere, , Finland
Novo Nordisk Investigational Site
Turku, , Finland
Novo Nordisk Investigational Site
Turku, , Finland
Novo Nordisk Investigational Site
Berlin, , Germany
Novo Nordisk Investigational Site
Friedrichsthal, , Germany
Novo Nordisk Investigational Site
Hohenmölsen, , Germany
Novo Nordisk Investigational Site
Münster, , Germany
Novo Nordisk Investigational Site
Neuwied, , Germany
Novo Nordisk Investigational Site
Völklingen, , Germany
Novo Nordisk Investigational Site
Almería, , Spain
Novo Nordisk Investigational Site
Antequera, , Spain
Novo Nordisk Investigational Site
Gijón, , Spain
Novo Nordisk Investigational Site
Málaga, , Spain
Novo Nordisk Investigational Site
Palma de Mallorca, , Spain
Novo Nordisk Investigational Site
Palma de Mallorca, , Spain
Novo Nordisk Investigational Site
Pozuelo de Alarcón, , Spain
Countries
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References
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Philis-Tsimikas A, Brod M, Niemeyer M, Ocampo Francisco AM, Rothman J. Insulin degludec once-daily in type 2 diabetes: simple or step-wise titration (BEGIN: once simple use). Adv Ther. 2013 Jun;30(6):607-22. doi: 10.1007/s12325-013-0036-1. Epub 2013 Jun 29.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1117-0616
Identifier Type: OTHER
Identifier Source: secondary_id
2010-022337-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN1250-3846
Identifier Type: -
Identifier Source: org_study_id
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