Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes
NCT ID: NCT01059799
Last Updated: 2017-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
435 participants
INTERVENTIONAL
2010-02-01
2010-12-16
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 OD
insulin degludec
Insulin degludec injected subcutaneously (under the skin) once daily. The doses will be individually adjusted
IGlar OD
insulin glargine
Insulin glargine injected subcutaneously (under the skin) once daily. The doses will be individually adjusted
Interventions
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insulin degludec
Insulin degludec injected subcutaneously (under the skin) once daily. The doses will be individually adjusted
insulin glargine
Insulin glargine injected subcutaneously (under the skin) once daily. The doses will be individually adjusted
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
* Current treatment with monotherapy or combination of an insulin secretagouge (sulfonylurea or glinide) and metformin, with or without addition of alfa-glucosidase-inhibitors or a DPP-4 inhibitor with unchanged dosing for at least 3 months prior to visit 1. The dose(s) should as minimum be as stated: -Insulin secretagogue (sulfonylurea or glinide): Minimum half of the daily maximal dose according to local labelling -Metformin: alone or in combination (including fixed combination): Maximum tolerated dose - alfa-glucosidase-inhibitors: Minimum half of the daily maximal dose or maximum tolerated dose -DPP-4 (dipeptyl peptidase 4) inhibitor: According to local labelling
* HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
* Body Mass Index (BMI) no higher than 35.0 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, or the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for Thailand: adequate contraceptive measures are: diaphragm, condom (by the partner), intrauterine device in place for last three months before trial starts, sponge, cap with spermicide, contraceptive patch, approved hormonal implant (i.e. Norplant), oral contraceptives taken without difficulty for the last three months before trial starts, post menopausal state or sterilisation.)
* Cancer and medical history of cancer (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
Shatin, New Territories, , Hong Kong
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Kamakura-shi, Kanagawa, , Japan
Novo Nordisk Investigational Site
Kawasaki-shi, , Japan
Novo Nordisk Investigational Site
Miyazaki, , Japan
Novo Nordisk Investigational Site
Naka-shi, Ibaraki, , Japan
Novo Nordisk Investigational Site
Nishinomiya-shi, Hygo, , Japan
Novo Nordisk Investigational Site
Ogawa, , Japan
Novo Nordisk Investigational Site
Ota-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Oyama-shi, Tochigi, , Japan
Novo Nordisk Investigational Site
Ōita, , Japan
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, , Japan
Novo Nordisk Investigational Site
Takatsuki-shi, Osaka, , Japan
Novo Nordisk Investigational Site
Cheras, , Malaysia
Novo Nordisk Investigational Site
George Town, , Malaysia
Novo Nordisk Investigational Site
Georgetown, Penang, , Malaysia
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, , Malaysia
Novo Nordisk Investigational Site
Kuala Lumpur, , Malaysia
Novo Nordisk Investigational Site
Kuala Lumpur, , Malaysia
Novo Nordisk Investigational Site
Kuala Selangor, , Malaysia
Novo Nordisk Investigational Site
Putrajaya, , Malaysia
Novo Nordisk Investigational Site
Bucheon-si, , South Korea
Novo Nordisk Investigational Site
Busan, , South Korea
Novo Nordisk Investigational Site
Goyang, , South Korea
Novo Nordisk Investigational Site
Goyang, , South Korea
Novo Nordisk Investigational Site
Incheon, , South Korea
Novo Nordisk Investigational Site
Jeonju, , South Korea
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Suwon, , South Korea
Novo Nordisk Investigational Site
Suwon, , South Korea
Novo Nordisk Investigational Site
Wŏnju, , South Korea
Novo Nordisk Investigational Site
Yangsan, , South Korea
Novo Nordisk Investigational Site
Banqiao District, , Taiwan
Novo Nordisk Investigational Site
Changhua, , Taiwan
Novo Nordisk Investigational Site
Chiayi City, , Taiwan
Novo Nordisk Investigational Site
Kaohsiung City, , Taiwan
Novo Nordisk Investigational Site
Kaoshiung, , Taiwan
Novo Nordisk Investigational Site
Taichung, , Taiwan
Novo Nordisk Investigational Site
Taipei, , Taiwan
Novo Nordisk Investigational Site
Bangkok, , Thailand
Novo Nordisk Investigational Site
Bangkok, , Thailand
Novo Nordisk Investigational Site
Bangkoknoi, Bangkok, , Thailand
Novo Nordisk Investigational Site
Chiang Mai, , Thailand
Novo Nordisk Investigational Site
Nakhon Ratchasima, , Thailand
Novo Nordisk Investigational Site
Songkhla, , Thailand
Countries
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References
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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.
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.
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.
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.
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.
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.
Onishi Y, Iwamoto Y, Yoo SJ, Clauson P, Tamer SC, Park S. Insulin degludec compared with insulin glargine in insulin-naive patients with type 2 diabetes: A 26-week, randomized, controlled, Pan-Asian, treat-to-target trial. J Diabetes Investig. 2013 Nov 27;4(6):605-12. doi: 10.1111/jdi.12102. Epub 2013 Jun 3.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1113-2441
Identifier Type: OTHER
Identifier Source: secondary_id
JapicCTI-101039
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN1250-3586
Identifier Type: -
Identifier Source: org_study_id
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