Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes
NCT ID: NCT01068678
Last Updated: 2017-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
460 participants
INTERVENTIONAL
2010-02-28
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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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IDeg 3 times weekly (3TW)
insulin degludec
Injected subcutaneously (under the skin) three times weekly. Dose was individually adjusted.
IGlar OD
insulin glargine
Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
Interventions
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insulin degludec
Injected subcutaneously (under the skin) three times weekly. Dose was individually adjusted.
insulin glargine
Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
Eligibility Criteria
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Inclusion Criteria
* 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 three 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 secretaguogue (sulfonylurea 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
* Body Mass Index (BMI) 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 (for UK: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods)
* 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
Northridge, California, United States
Novo Nordisk Investigational Site
Palm Springs, California, United States
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Paramount, California, United States
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Santa Ana, California, United States
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Spring Valley, California, United States
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Tustin, California, United States
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Melbourne, Florida, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Perry, Georgia, United States
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Olympia Fields, Illinois, United States
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Avon, Indiana, United States
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Fishers, Indiana, United States
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Franklin, Indiana, United States
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Indianapolis, Indiana, United States
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Muncie, Indiana, United States
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Des Moines, Iowa, United States
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Lexington, Kentucky, United States
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Paducah, Kentucky, United States
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Hyattsville, Maryland, United States
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Rockville, Maryland, United States
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Interlochen, Michigan, United States
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Jackson, Mississippi, United States
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Chesterfield, Missouri, United States
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City of Saint Peters, Missouri, United States
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Billings, Montana, United States
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Lincoln, Nebraska, United States
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Hamilton, New Jersey, United States
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Toms River, New Jersey, United States
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Syracuse, New York, United States
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West Seneca, New York, United States
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Durham, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Canton, Ohio, United States
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
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Mentor, Ohio, United States
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Pottstown, Pennsylvania, United States
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Upper St.Clair, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greer, South Carolina, United States
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Simpsonville, South Carolina, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Arlington, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Fredericksburg, Virginia, United States
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Richmond, Virginia, United States
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Virginia Beach, Virginia, United States
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Menomonee Falls, Wisconsin, United States
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Greater Sudbury, Ontario, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Sarnia, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Mirabel, Quebec, Canada
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Sherbrooke, Quebec, Canada
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St. John's, , Canada
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Brandýs nad Labem, , Czechia
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Mladá Boleslav, , Czechia
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Ostrava, , Czechia
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Prague, , Czechia
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Trutnov, , Czechia
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Petah Tikva, , Israel
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Rehovot, , Israel
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Rishon LeZiyyon, , Israel
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Safed, , Israel
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Tel Litwinsky, , Israel
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Manatí, , Puerto Rico
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Bratislava, , Slovakia
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Košice, , Slovakia
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Moldava nad Bodvou, , Slovakia
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Nové Zámky, , Slovakia
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Prešov, , Slovakia
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Johannesburg, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Aberdeen, , United Kingdom
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Aldershot, , United Kingdom
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Birmingham, , United Kingdom
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Chippenham, , United Kingdom
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Exeter, , United Kingdom
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Guildford, , United Kingdom
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Nuneaton, , United Kingdom
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Portsmouth, , United Kingdom
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Watford, , United Kingdom
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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2009-011398-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1113-2412
Identifier Type: OTHER
Identifier Source: secondary_id
NN1250-3724
Identifier Type: -
Identifier Source: org_study_id
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