Comparison of Two Insulin Degludec Formulations in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT01364428
Last Updated: 2017-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
373 participants
INTERVENTIONAL
2011-06-30
2012-01-31
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 200 U/mL
insulin degludec
Injected subcutaneously (under the skin) once daily, in combination with unchanged pre-trial oral anti-diabetic drug (OAD) treatment.
Dose was individually adjusted.
IDeg 100 U/mL
insulin degludec
Injected subcutaneously (under the skin) once daily, in combination with unchanged pre-trial oral anti-diabetic drug (OAD) treatment.
Dose was individually adjusted.
Interventions
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insulin degludec
Injected subcutaneously (under the skin) once daily, in combination with unchanged pre-trial oral anti-diabetic drug (OAD) treatment.
Dose was individually adjusted.
insulin degludec
Injected subcutaneously (under the skin) once daily, in combination with unchanged pre-trial oral anti-diabetic drug (OAD) treatment.
Dose was individually adjusted.
Eligibility Criteria
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Inclusion Criteria
* Current treatment with basal-only insulin (no prandial insulin) consisting of either insulin detemir once daily (OD), insulin glargine OD or neutral protamine hagedorn (NPH) insulin OD/twice daily (BID) for at least 12 weeks prior to randomisation (visit 2), in combination with stable doses of OAD(s) (metformin, insulin secretagogue (sulfonylurea or glinide), alpha-glucosidase inhibitor, pioglitazone or dipeptidyl peptidase IV (DPP-IV) inhibitor in any approved (according to label) dose or combination. Stable OAD doses are defined as unchanged doses for at least 12 weeks prior to randomisation (visit 2)
* HbA1c (glycosylated haemoglobin) between 7.0-10.0% (both inclusive) by central laboratory analysis
* Body mass index (BMI) below or equal to 45 kg/m\^2
* Ability and willingness to adhere to the protocol including self-measured plasma glucose (SMPG) according to the protocol
Exclusion Criteria
* Treatment with glucagon like peptide-1 (GLP-1) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
* Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)
* Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period
* Known or suspected hypersensitivity to trial products or related products
* The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)
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
Huntsville, Alabama, United States
Novo Nordisk Investigational Site
Goodyear, Arizona, United States
Novo Nordisk Investigational Site
Mesa, Arizona, United States
Novo Nordisk Investigational Site
Phoenix, Arizona, United States
Novo Nordisk Investigational Site
Concord, California, United States
Novo Nordisk Investigational Site
Greenbrae, California, United States
Novo Nordisk Investigational Site
Montclair, California, United States
Novo Nordisk Investigational Site
National City, California, United States
Novo Nordisk Investigational Site
Palm Springs, California, United States
Novo Nordisk Investigational Site
Bradenton, Florida, United States
Novo Nordisk Investigational Site
Clearwater, Florida, United States
Novo Nordisk Investigational Site
Kissimmee, Florida, United States
Novo Nordisk Investigational Site
Miami, Florida, United States
Novo Nordisk Investigational Site
Tampa, Florida, United States
Novo Nordisk Investigational Site
West Palm Beach, Florida, United States
Novo Nordisk Investigational Site
Atlanta, Georgia, United States
Novo Nordisk Investigational Site
Springfield, Illinois, United States
Novo Nordisk Investigational Site
Evansville, Indiana, United States
Novo Nordisk Investigational Site
Metairie, Louisiana, United States
Novo Nordisk Investigational Site
Slidell, Louisiana, United States
Novo Nordisk Investigational Site
Rockville, Maryland, United States
Novo Nordisk Investigational Site
Waltham, Massachusetts, United States
Novo Nordisk Investigational Site
Detroit, Michigan, United States
Novo Nordisk Investigational Site
Jefferson City, Missouri, United States
Novo Nordisk Investigational Site
Omaha, Nebraska, United States
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, United States
Novo Nordisk Investigational Site
Toms River, New Jersey, United States
Novo Nordisk Investigational Site
Staten Island, New York, United States
Novo Nordisk Investigational Site
West Seneca, New York, United States
Novo Nordisk Investigational Site
Greensboro, North Carolina, United States
Novo Nordisk Investigational Site
Greenville, North Carolina, United States
Novo Nordisk Investigational Site
Canton, Ohio, United States
Novo Nordisk Investigational Site
Franklin, Ohio, United States
Novo Nordisk Investigational Site
Melrose Park, Pennsylvania, United States
Novo Nordisk Investigational Site
Brentwood, Tennessee, United States
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Hurst, Texas, United States
Novo Nordisk Investigational Site
Irving, Texas, United States
Novo Nordisk Investigational Site
Round Rock, Texas, United States
Novo Nordisk Investigational Site
San Antonio, Texas, United States
Novo Nordisk Investigational Site
Olympia, Washington, United States
Novo Nordisk Investigational Site
Renton, Washington, United States
Countries
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References
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Bode BW, Chaykin LB, Sussman AM, Warren ML, Niemeyer M, Rabol R, Rodbard HW. Efficacy and Safety of Insulin Degludec 200 U/mL and Insulin Degludec 100 U/mL in Patients with Type 2 Diabetes (Begin: Compare). Endocr Pract. 2014 Aug;20(8):785-91. doi: 10.4158/EP13411.OR.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1119-2518
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN1250-3923
Identifier Type: -
Identifier Source: org_study_id
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