Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes
NCT ID: NCT01076647
Last Updated: 2017-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
467 participants
INTERVENTIONAL
2010-03-31
2010-12-31
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 3TW
insulin degludec
Will be injected subcutaneously (under the skin) once daily three times weekly.
IGlar OD
insulin glargine
Will be injected subcutaneously (under the skin) once daily administered at the same time each day.
Interventions
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insulin degludec
Will be injected subcutaneously (under the skin) once daily three times weekly.
insulin glargine
Will be injected subcutaneously (under the skin) once daily administered at the same time each day.
Eligibility Criteria
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Inclusion Criteria
* Insulin naïve subjects (allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
* Current treatment: metformin monotherapy or metformin in any combination with insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination) 1500 mg daily or maximum tolerated dose (at least 1000 mg daily)-Insulin secretagogue (sulfonylurea (SU) or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
* HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
* BMI (Body Mass Index) below or equal to 45.0 kg/m\^2
Exclusion Criteria
* Cardiovascular disease, within the last 6 months prior to visit 1, 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
* Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
* Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)
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
Peoria, Arizona, United States
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Tucson, Arizona, United States
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Beverly Hills, California, United States
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Escondido, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Los Banos, California, United States
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Monterey, California, United States
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Palm Springs, California, United States
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Pasadena, California, United States
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Redondo Beach, California, United States
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San Mateo, California, United States
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Tarzana, California, United States
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Tustin, California, United States
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Denver, Colorado, United States
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Golden, Colorado, United States
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Boynton Beach, Florida, United States
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DeLand, Florida, United States
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Kissimmee, Florida, United States
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Miami, Florida, United States
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Orange Park, Florida, United States
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Plantation, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Conyers, Georgia, United States
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Dunwoody, Georgia, United States
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Arlington Heights, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Springfield, Illinois, United States
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Wichita, Kansas, United States
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Crestview Hills, Kentucky, United States
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Madisonville, Kentucky, United States
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Metairie, Louisiana, United States
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Glen Burnie, Maryland, United States
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Reisterstown, Maryland, United States
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Silver Spring, Maryland, United States
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Ann Arbor, Michigan, United States
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Eagan, Minnesota, United States
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Smithtown, New York, United States
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Staten Island, New York, United States
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Asheville, North Carolina, United States
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Burlington, North Carolina, United States
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Whiteville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Altoona, Pennsylvania, United States
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Altoona, Pennsylvania, United States
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Harrisburg, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Newberry, South Carolina, United States
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Chattanooga, Tennessee, United States
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Kingsport, Tennessee, United States
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Arlington, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Round Rock, Texas, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Salt Lake City, Utah, United States
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Chesapeake, Virginia, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Burgas, , Bulgaria
Novo Nordisk Investigational Site
Rousse, , Bulgaria
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Sofia, , Bulgaria
Novo Nordisk Investigational Site
Stara Zagora, , Bulgaria
Novo Nordisk Investigational Site
Chilliwack, British Columbia, Canada
Novo Nordisk Investigational Site
Ottawa, Ontario, Canada
Novo Nordisk Investigational Site
Thornhill, Ontario, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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La Roche-sur-Yon, , France
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La Rochelle, , France
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Le Creusot, , France
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Nanterre, , France
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Narbonne, , France
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Nîmes, , France
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Paris, , France
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Vénissieux, , France
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Budapest, , Hungary
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Debrecen, , Hungary
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Eger, , Hungary
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Gyula, , Hungary
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Kaposvár, , Hungary
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Szeged, , Hungary
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Amsterdam, , Netherlands
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Beek, , Netherlands
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Etten-Leur, , Netherlands
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Hengelo, , Netherlands
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Hoogeveen, , Netherlands
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Lieshout, , Netherlands
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Utrecht, , Netherlands
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Zwijndrecht, , Netherlands
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Oradea, Bihor County, Romania
Novo Nordisk Investigational Site
Satu Mare, Satu Mare County, Romania
Novo Nordisk Investigational Site
Bacau, , Romania
Novo Nordisk Investigational Site
Botoșani, , Romania
Novo Nordisk Investigational Site
Bucharest, , Romania
Novo Nordisk Investigational Site
Galati, , Romania
Countries
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References
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Zinman B, DeVries JH, Bode B, Russell-Jones D, Leiter LA, Moses A, Johansen T, Ratner R; NN1250-3724 (BEGIN:EASY AM) and NN1250-3718 (BEGIN:EASY PM) Trial Investigators. Efficacy and safety of insulin degludec three times a week versus insulin glargine once a day in insulin-naive patients with type 2 diabetes: results of two phase 3, 26 week, randomised, open-label, treat-to-target, non-inferiority trials. Lancet Diabetes Endocrinol. 2013 Oct;1(2):123-31. doi: 10.1016/S2213-8587(13)70013-5. Epub 2013 Jul 9.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2009-011399-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1112-8770
Identifier Type: OTHER
Identifier Source: secondary_id
NN1250-3718
Identifier Type: -
Identifier Source: org_study_id
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