Comparison of NN1250 With Insulin Glargine in Type 2 Diabetes
NCT ID: NCT01006291
Last Updated: 2017-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
687 participants
INTERVENTIONAL
2009-11-30
2010-09-30
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 OD FF
insulin degludec
Injected s.c. (under the skin) once daily (alternative regimen). Dose was individually adjusted.
IDeg OD
insulin degludec
Injected s.c. (under the skin) once daily. Dose was individually adjusted.
IGlar OD
insulin glargine
Insulin glargine injected s.c. (under the skin) once daily. Dose was individually adjusted.
Interventions
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insulin degludec
Injected s.c. (under the skin) once daily (alternative regimen). Dose was individually adjusted.
insulin degludec
Injected s.c. (under the skin) once daily. Dose was individually adjusted.
insulin glargine
Insulin glargine injected s.c. (under the skin) once daily. Dose was individually adjusted.
Eligibility Criteria
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Inclusion Criteria
* Current treatment: oral anti-diabetic drug(s) (OAD(s)) alone, basal insulin alone or the combination of OAD(s) and basal insulin. Allowed OADs are: Metformin, insulin secretagogues (sulphonylureas (SU) or glinides), pioglitazone with unchanged dosing for at least 3 months prior to Visit 1
* HbA1c: OADs only users 7.0-11.0 % (both inclusive), basal insulin with/without OADs users 7.0-10.0% (both inclusive) by central laboratory analysis
* Body Mass Index (BMI) below or equal to 40.0 kg/m\^2
Exclusion Criteria
* Use within the last 3 months prior to Visit 1 of: glucagon-like peptide-1(GLP-1) receptor agonist (exenatide, liraglutide), rosiglitazone, dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase-inhibitors
* 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 and 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
Buenos Aires, , Argentina
Novo Nordisk Investigational Site
Buenos Aires, , Argentina
Novo Nordisk Investigational Site
Ciudad Autónoma de Bs As, , Argentina
Novo Nordisk Investigational Site
Rosario, , Argentina
Novo Nordisk Investigational Site
Hanko, , Finland
Novo Nordisk Investigational Site
Harjavalta, , Finland
Novo Nordisk Investigational Site
Oulu, , Finland
Novo Nordisk Investigational Site
Tampere, , Finland
Novo Nordisk Investigational Site
Turku, , Finland
Novo Nordisk Investigational Site
Turku, , Finland
Novo Nordisk Investigational Site
Vantaa, , Finland
Novo Nordisk Investigational Site
Budapest, , Hungary
Novo Nordisk Investigational Site
Debrecen, , Hungary
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Győr, , Hungary
Novo Nordisk Investigational Site
Szombathely, , Hungary
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India
Novo Nordisk Investigational Site
Kochi, Kerala, India
Novo Nordisk Investigational Site
Indore, Madhya Pradesh, India
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India
Novo Nordisk Investigational Site
New Dehli, New Delhi, India
Novo Nordisk Investigational Site
Chandigarh, Punjab, India
Novo Nordisk Investigational Site
Vellore, Tamil Nadu, India
Novo Nordisk Investigational Site
Kolkata, West Bengal, India
Novo Nordisk Investigational Site
Kolkata, West Bengal, India
Novo Nordisk Investigational Site
Chennai, , India
Novo Nordisk Investigational Site
Hyderabad, , India
Novo Nordisk Investigational Site
Beersheba, , Israel
Novo Nordisk Investigational Site
Haifa, , Israel
Novo Nordisk Investigational Site
Holon, , Israel
Novo Nordisk Investigational Site
Jerusalem, , Israel
Novo Nordisk Investigational Site
Kfar Saba, , Israel
Novo Nordisk Investigational Site
Netanya, , Israel
Novo Nordisk Investigational Site
Petah Tikva, , Israel
Novo Nordisk Investigational Site
Rehovot, , Israel
Novo Nordisk Investigational Site
Cheras, , Malaysia
Novo Nordisk Investigational Site
George Town, , Malaysia
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, , Malaysia
Novo Nordisk Investigational Site
Kuala Lumpur, , Malaysia
Novo Nordisk Investigational Site
Putrajaya, , Malaysia
Novo Nordisk Investigational Site
Durango, Durango, Mexico
Novo Nordisk Investigational Site
Mexico City, México, D.F., Mexico
Novo Nordisk Investigational Site
Monterrey, , Mexico
Novo Nordisk Investigational Site
Skopje, , North Macedonia
Novo Nordisk Investigational Site
Gjøvik, , Norway
Novo Nordisk Investigational Site
Hamar, , Norway
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Hønefoss, , Norway
Novo Nordisk Investigational Site
Oslo, , Norway
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Stavanger, , Norway
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Tønsberg, , Norway
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Kazan', , Russia
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Saint Petersburg, , Russia
Novo Nordisk Investigational Site
Saint-Peterburg, , Russia
Novo Nordisk Investigational Site
Belgrade, , Serbia
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa
Novo Nordisk Investigational Site
Taipei, , Taiwan
Novo Nordisk Investigational Site
Taipei, , Taiwan
Novo Nordisk Investigational Site
Taipei, , Taiwan
Novo Nordisk Investigational Site
Taoyuan District, , Taiwan
Novo Nordisk Investigational Site
Belfast, , United Kingdom
Novo Nordisk Investigational Site
Edgbaston, Birmingham, , United Kingdom
Novo Nordisk Investigational Site
Edinburgh, , United Kingdom
Novo Nordisk Investigational Site
Glasgow, , United Kingdom
Novo Nordisk Investigational Site
Hull, , United Kingdom
Novo Nordisk Investigational Site
Ipswich, , United Kingdom
Novo Nordisk Investigational Site
Londonderry, , United Kingdom
Novo Nordisk Investigational Site
Swansea, , United Kingdom
Countries
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References
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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.
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.
Meneghini L, Atkin SL, Gough SC, Raz I, Blonde L, Shestakova M, Bain S, Johansen T, Begtrup K, Birkeland KI; NN1250-3668 (BEGIN FLEX) Trial Investigators. The efficacy and safety of insulin degludec given in variable once-daily dosing intervals compared with insulin glargine and insulin degludec dosed at the same time daily: a 26-week, randomized, open-label, parallel-group, treat-to-target trial in individuals with type 2 diabetes. Diabetes Care. 2013 Apr;36(4):858-64. doi: 10.2337/dc12-1668. Epub 2013 Jan 22.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1111-7084
Identifier Type: OTHER
Identifier Source: secondary_id
2008-005771-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN1250-3668
Identifier Type: -
Identifier Source: org_study_id
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