A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin
NCT ID: NCT01713530
Last Updated: 2018-04-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
274 participants
INTERVENTIONAL
2013-02-21
2014-01-09
Brief Summary
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The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.
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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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IDegAsp BID+/-OADs
insulin degludec/insulin aspart
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration twice a day.
IDeg OD plus IAsp +/-OADs
insulin degludec
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration once daily.
insulin aspart
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration with the main meals 2-4 times daily in accordance with local labelling.
Interventions
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insulin degludec/insulin aspart
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration twice a day.
insulin degludec
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration once daily.
insulin aspart
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration with the main meals 2-4 times daily in accordance with local labelling.
Eligibility Criteria
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Inclusion Criteria
* Treatment with basal insulin for at least 12 weeks prior to randomisation with or without metformin, sulphonylurea (SU)/glinide, DPP-4 inhibitors, alfa-glucosidase-inhibitors
* HbA1c 7.0% - 10.0%
* Body mass index (BMI) less than or equal to 40.0 kg/m\^2
* Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
* Chronic disorder or disease which might jeopardise safety or compliance
* Malignant neoplasms
* Recurrent severe hypoglycaemia
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
Greenbrae, California, United States
Novo Nordisk Investigational Site
Mission Hills, California, United States
Novo Nordisk Investigational Site
San Diego, California, United States
Novo Nordisk Investigational Site
Kissimmee, Florida, United States
Novo Nordisk Investigational Site
Chicago, Illinois, United States
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States
Novo Nordisk Investigational Site
Slidell, Louisiana, United States
Novo Nordisk Investigational Site
Rockville, Maryland, United States
Novo Nordisk Investigational Site
Buckley, Michigan, United States
Novo Nordisk Investigational Site
Hillsborough, New Jersey, United States
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, United States
Novo Nordisk Investigational Site
Toms River, New Jersey, United States
Novo Nordisk Investigational Site
Greensboro, North Carolina, United States
Novo Nordisk Investigational Site
Whiteville, North Carolina, United States
Novo Nordisk Investigational Site
Kettering, Ohio, United States
Novo Nordisk Investigational Site
Wadsworth, Ohio, United States
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States
Novo Nordisk Investigational Site
Kingsport, Tennessee, United States
Novo Nordisk Investigational Site
Austin, Texas, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Houston, Texas, United States
Novo Nordisk Investigational Site
Round Rock, Texas, United States
Novo Nordisk Investigational Site
San Antonio, Texas, United States
Novo Nordisk Investigational Site
Tacoma, Washington, United States
Novo Nordisk Investigational Site
Martinsburg, West Virginia, United States
Novo Nordisk Investigational Site
Algiers, , Algeria
Novo Nordisk Investigational Site
Annaba, , Algeria
Novo Nordisk Investigational Site
Constantine, , Algeria
Novo Nordisk Investigational Site
Oran, , Algeria
Novo Nordisk Investigational Site
Graz, , Austria
Novo Nordisk Investigational Site
Innsbruck, , Austria
Novo Nordisk Investigational Site
Linz, , Austria
Novo Nordisk Investigational Site
Mödling, , Austria
Novo Nordisk Investigational Site
Salzburg, , Austria
Novo Nordisk Investigational Site
Vienna, , Austria
Novo Nordisk Investigational Site
Vienna, , Austria
Novo Nordisk Investigational Site
Caen, , France
Novo Nordisk Investigational Site
La Roche-sur-Yon, , France
Novo Nordisk Investigational Site
La Rochelle, , France
Novo Nordisk Investigational Site
Le Creusot, , France
Novo Nordisk Investigational Site
Montpellier, , France
Novo Nordisk Investigational Site
Montpellier, , France
Novo Nordisk Investigational Site
Saint-Herblain, , France
Novo Nordisk Investigational Site
Vénissieux, , France
Novo Nordisk Investigational Site
Hamar, , Norway
Novo Nordisk Investigational Site
Kongsvinger, , Norway
Novo Nordisk Investigational Site
Kristiansand, , Norway
Novo Nordisk Investigational Site
Oslo, , Norway
Novo Nordisk Investigational Site
Skedsmokorset, , Norway
Novo Nordisk Investigational Site
Stavanger, , Norway
Countries
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References
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Rodbard HW, Cariou B, Pieber TR, Endahl LA, Zacho J, Cooper JG. Treatment intensification with an insulin degludec (IDeg)/insulin aspart (IAsp) co-formulation twice daily compared with basal IDeg and prandial IAsp in type 2 diabetes: a randomized, controlled phase III trial. Diabetes Obes Metab. 2016 Mar;18(3):274-80. doi: 10.1111/dom.12609. Epub 2016 Jan 11.
Haluzik M, Fulcher G, Pieber TR, Bardtrum L, Tutkunkardas D, Rodbard HW. The co-formulation of insulin degludec and insulin aspart lowers fasting plasma glucose and rates of confirmed and nocturnal hypoglycaemia, independent of baseline glycated haemoglobin levels, disease duration or body mass index: A pooled meta-analysis of phase III studies in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jul;20(7):1585-1592. doi: 10.1111/dom.13261. Epub 2018 Mar 25.
Yang W, Akhtar S, Franek E, Haluzik M, Hirose T, Kalyanam B, Kar S, Wu T, Gogas Yavuz D, Unnikrishnan AG. Postprandial Glucose Excursions in Asian Versus Non-Asian Patients with Type 2 Diabetes: A Post Hoc Analysis of Baseline Data from Phase 3 Randomised Controlled Trials of IDegAsp. Diabetes Ther. 2022 Feb;13(2):311-323. doi: 10.1007/s13300-021-01196-7. Epub 2022 Jan 19.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2012-002346-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1130-7135
Identifier Type: OTHER
Identifier Source: secondary_id
NN5401-3996
Identifier Type: -
Identifier Source: org_study_id
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