Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™)
NCT ID: NCT01135992
Last Updated: 2016-01-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
143 participants
INTERVENTIONAL
2010-06-30
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IGlar/IDeg
insulin glargine
Subjects continue their pre-trial insulin glargine once daily plus OAD (oral anti-diabetic drug) treatment for four weeks before switch to insulin degludec
IDeg 3TW
insulin degludec
Individually adjusted insulin degludec administered three times weekly with continued unchanged pre-trial OAD (oral anti-diabetic drug) treatment for 12 weeks
Interventions
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insulin degludec
Individually adjusted insulin degludec administered three times weekly with continued unchanged pre-trial OAD (oral anti-diabetic drug) treatment for 12 weeks
insulin glargine
Subjects continue their pre-trial insulin glargine once daily plus OAD (oral anti-diabetic drug) treatment for four weeks before switch to insulin degludec
Eligibility Criteria
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Inclusion Criteria
* HbA1c maximum 10 % by central laboratory analysis
* Current treatment with basal-oral therapy (BOT) (no prandial insulin ever) consisting of: at least three months with insulin glargine once daily (average prescribed dose must have been unchanged (within plus/minus 10%) for four weeks prior to Visit 1 as confirmed by patient records or verbal confirmation by the subject) in combination with stable (unchanged doses for at least 3 months prior to Visit 1) OAD (metformin, insulin secretagogues, pioglitazone, sitagliptin or alpha-glucosidase-inhibitor) treatment in any approved (according to label) dose or combination
Exclusion Criteria
* Cardiovascular disease (CVD) defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty within the last six months prior to Visit 1
* Recurrent severe hypoglycaemia (more than one severe hypoglycaemic episode during the last 12 months), or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous six months
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
* Previous participation in this trial. Participation is defined as started on trial medication. Rescreening of screening failures is allowed only once within the limits of the recruitment period
* Known or suspected hypersensitivity to trial products or related products
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 Clinical Trial Call Center
Goodyear, Arizona, United States
Novo Nordisk Clinical Trial Call Center
Phoenix, Arizona, United States
Novo Nordisk Clinical Trial Call Center
Anaheim, California, United States
Novo Nordisk Clinical Trial Call Center
Chino, California, United States
Novo Nordisk Clinical Trial Call Center
Concord, California, United States
Novo Nordisk Clinical Trial Call Center
Fresno, California, United States
Novo Nordisk Clinical Trial Call Center
Greenbrae, California, United States
Novo Nordisk Clinical Trial Call Center
Palm Springs, California, United States
Novo Nordisk Clinical Trial Call Center
Kissimmee, Florida, United States
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States
Novo Nordisk Clinical Trial Call Center
Metairie, Louisiana, United States
Novo Nordisk Clinical Trial Call Center
Metairie, Louisiana, United States
Novo Nordisk Clinical Trial Call Center
Omaha, Nebraska, United States
Novo Nordisk Clinical Trial Call Center
Henderson, Nevada, United States
Novo Nordisk Clinical Trial Call Center
Dover, New Hampshire, United States
Novo Nordisk Clinical Trial Call Center
Nashua, New Hampshire, United States
Novo Nordisk Clinical Trial Call Center
Lawrenceville, New Jersey, United States
Novo Nordisk Clinical Trial Call Center
Toms River, New Jersey, United States
Novo Nordisk Clinical Trial Call Center
Albany, New York, United States
Novo Nordisk Clinical Trial Call Center
Charlotte, North Carolina, United States
Novo Nordisk Clinical Trial Call Center
Melrose Park, Pennsylvania, United States
Novo Nordisk Clinical Trial Call Center
Pittsburgh, Pennsylvania, United States
Novo Nordisk Clinical Trial Call Center
Chattanooga, Tennessee, United States
Novo Nordisk Clinical Trial Call Center
Kingsport, Tennessee, United States
Novo Nordisk Clinical Trial Call Center
Austin, Texas, United States
Novo Nordisk Clinical Trial Call Center
Fort Worth, Texas, United States
Novo Nordisk Clinical Trial Call Center
Olympia, Washington, United States
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1114-8802
Identifier Type: OTHER
Identifier Source: secondary_id
NN1250-3839
Identifier Type: -
Identifier Source: org_study_id
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