Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes
NCT ID: NCT01068665
Last Updated: 2017-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
460 participants
INTERVENTIONAL
2010-03-31
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 200 U/mL OD
insulin degludec
Injected subcutaneously (under the skin) once daily. 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) once daily. 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 an insulin secretagogue (sulfonylurea or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitors (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 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-inhibitors (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) maximum 45.0 kg/m\^2
* Type 2 diabetes (diagnosed clinically) for at least 6 months
* Ability and willingness to adhere to the protocol including performance of self monitored plasma glucose (SMPG) profiles according to the protocol
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
Huntsville, Alabama, United States
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Gilbert, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Anaheim, California, United States
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Huntington Beach, California, United States
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Mission Hills, California, United States
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Montclair, California, United States
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National City, California, United States
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Norco, California, United States
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San Diego, California, United States
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Valencia, California, United States
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Walnut Creek, California, United States
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Aurora, Colorado, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Longwood, Florida, United States
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Ocala, Florida, United States
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Ponte Vedra, Florida, United States
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Vero Beach, Florida, United States
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Decatur, Georgia, United States
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Lawrenceville, Georgia, United States
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Roswell, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Crystal Lake, Illinois, United States
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Evansville, Indiana, United States
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Greenfield, Indiana, United States
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Des Moines, Iowa, United States
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Madisonville, Kentucky, United States
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Slidell, Louisiana, United States
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Greenbelt, Maryland, United States
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Brockton, Massachusetts, United States
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Southfield, Michigan, United States
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Southfield, Michigan, United States
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Troy, Michigan, United States
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Minneapolis, Minnesota, United States
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Biloxi, Mississippi, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Brick, New Jersey, United States
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Mine Hill, New Jersey, United States
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Brooklyn, New York, United States
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New York, New York, United States
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Asheboro, North Carolina, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
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Franklin, Ohio, United States
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Beaver, Pennsylvania, United States
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Melrose Park, Pennsylvania, United States
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Norristown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Peak, South Carolina, United States
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DeSoto, Texas, United States
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El Paso, Texas, United States
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Killeen, Texas, United States
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Plano, Texas, United States
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Sugar Land, Texas, United States
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St. George, Utah, United States
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Renton, Washington, United States
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Milwaukee, Wisconsin, United States
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Langley, British Columbia, Canada
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Cambridge, Ontario, Canada
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Cornwall, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Hamilton, Ontario, Canada
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Hamilton, Ontario, Canada
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Hamilton, Ontario, Canada
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Mississauga, Ontario, Canada
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Saint Romuald, Quebec, Canada
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Antibes, , France
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Besançon, , France
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Narbonne, , France
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Pointe à Pitre, , France
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Rennes, , France
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Sète, , France
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Vénissieux, , France
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Dublin, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Kemerovo, , Russia
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Krasnoyarsk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Voronezh, , Russia
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Yekaterinburg, , Russia
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East London, Eastern Cape, South Africa
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Port Elizabeth, Eastern Cape, South Africa
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Durban, KwaZulu-Natal, South Africa
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Alberton, , South Africa
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Kiev, , Ukraine
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Abergavenny, , United Kingdom
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Ashton-under-Lyne, , United Kingdom
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Atherstone, , United Kingdom
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Ayr, , United Kingdom
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Bath, , United Kingdom
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Bolton, , United Kingdom
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Chester, , United Kingdom
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Chorley, , United Kingdom
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Coventry, , United Kingdom
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Epworth, , United Kingdom
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Harrogate, , United Kingdom
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Letchworth Garden City, , United Kingdom
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Livingstone, , United Kingdom
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Llantrisant, , United Kingdom
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Maidstone, , United Kingdom
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Oldham, , United Kingdom
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Rugby, , United Kingdom
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Salford, , United Kingdom
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Trowbridge, , United Kingdom
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Whitby, , United Kingdom
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Wrexham, , United Kingdom
Countries
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References
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Weatherall J, Bloudek L, Buchs S. Budget impact of treating commercially insured type 1 and type 2 diabetes patients in the United States with insulin degludec compared to insulin glargine. Curr Med Res Opin. 2017 Feb;33(2):231-238. doi: 10.1080/03007995.2016.1251893. Epub 2016 Nov 18.
Ratner RE, Gough SC, Mathieu C, Del Prato S, Bode B, Mersebach H, Endahl L, Zinman B. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013 Feb;15(2):175-84. doi: 10.1111/dom.12032. Epub 2012 Dec 3.
Gough SC, Bhargava A, Jain R, Mersebach H, Rasmussen S, Bergenstal RM. Low-volume insulin degludec 200 units/ml once daily improves glycemic control similarly to insulin glargine with a low risk of hypoglycemia in insulin-naive patients with type 2 diabetes: a 26-week, randomized, controlled, multinational, treat-to-target trial: the BEGIN LOW VOLUME trial. Diabetes Care. 2013 Sep;36(9):2536-42. doi: 10.2337/dc12-2329. Epub 2013 May 28.
Heller S, Mathieu C, Kapur R, Wolden ML, Zinman B. A meta-analysis of rate ratios for nocturnal confirmed hypoglycaemia with insulin degludec vs. insulin glargine using different definitions for hypoglycaemia. Diabet Med. 2016 Apr;33(4):478-87. doi: 10.1111/dme.13002. Epub 2015 Dec 13.
Vora J, Christensen T, Rana A, Bain SC. Insulin degludec versus insulin glargine in type 1 and type 2 diabetes mellitus: a meta-analysis of endpoints in phase 3a trials. Diabetes Ther. 2014 Dec;5(2):435-46. doi: 10.1007/s13300-014-0076-9. Epub 2014 Aug 1.
Aye MM, Atkin SL. Patient safety and minimizing risk with insulin administration - role of insulin degludec. Drug Healthc Patient Saf. 2014 Apr 30;6:55-67. doi: 10.2147/DHPS.S59566. eCollection 2014.
Sorli C, Warren M, Oyer D, Mersebach H, Johansen T, Gough SC. Elderly patients with diabetes experience a lower rate of nocturnal hypoglycaemia with insulin degludec than with insulin glargine: a meta-analysis of phase IIIa trials. Drugs Aging. 2013 Dec;30(12):1009-18. doi: 10.1007/s40266-013-0128-2.
Einhorn D, Handelsman Y, Bode BW, Endahl LA, Mersebach H, King AB. PATIENTS ACHIEVING GOOD GLYCEMIC CONTROL (HBA1c <7%) EXPERIENCE A LOWER RATE OF HYPOGLYCEMIA WITH INSULIN DEGLUDEC THAN WITH INSULIN GLARGINE: A META-ANALYSIS OF PHASE 3A TRIALS. Endocr Pract. 2015 Aug;21(8):917-26. doi: 10.4158/EP14523.OR. Epub 2015 Jun 29.
Russell-Jones D, Gall MA, Niemeyer M, Diamant M, Del Prato S. Insulin degludec results in lower rates of nocturnal hypoglycaemia and fasting plasma glucose vs. insulin glargine: A meta-analysis of seven clinical trials. Nutr Metab Cardiovasc Dis. 2015 Oct;25(10):898-905. doi: 10.1016/j.numecd.2015.06.005. Epub 2015 Jun 18.
Vora J, Seufert J, Solberg H, Kinduryte O, Johansen T, Hollander P. Insulin degludec does not increase antibody formation versus insulin glargine: an evaluation of phase IIIa trials. Diabetes Obes Metab. 2016 Jul;18(7):716-20. doi: 10.1111/dom.12621. Epub 2016 Feb 8.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2009-010662-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1112-8977
Identifier Type: OTHER
Identifier Source: secondary_id
NN1250-3672
Identifier Type: -
Identifier Source: org_study_id
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