A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily
NCT ID: NCT01814137
Last Updated: 2017-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
40 participants
INTERVENTIONAL
2013-03-31
2014-03-31
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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IDegAsp BID + IAsp OD
insulin degludec/insulin aspart
For subcutaneous (s.c., under the skin) administration twice daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged).
insulin aspart
For subcutaneous (s.c., under the skin) administration once daily. Dose of IDegAsp and IAsp are individually adjusted.
IDeg OD + IAsp TID
insulin degludec
For subcutaneous (s.c., under the skin) administration once daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged).
insulin aspart
For subcutaneous (s.c., under the skin) administration three times a day. Dose of IDeg and IAsp are individually adjusted.
Interventions
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insulin degludec/insulin aspart
For subcutaneous (s.c., under the skin) administration twice daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged).
insulin degludec
For subcutaneous (s.c., under the skin) administration once daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged).
insulin aspart
For subcutaneous (s.c., under the skin) administration once daily. Dose of IDegAsp and IAsp are individually adjusted.
insulin aspart
For subcutaneous (s.c., under the skin) administration three times a day. Dose of IDeg and IAsp are individually adjusted.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Impaired liver function, defined as alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) equal to or above 2.5 times upper limit of normal
* Impaired renal function defined as serum-creatinine equal to or above 125 micromol/L (equal to or above 1.4 mg/dL) for males and equal to or above 110 micromol/L (equal to or above 1.3 mg/dL) for females
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
Goodyear, Arizona, United States
Novo Nordisk Investigational Site
Phoenix, Arizona, United States
Novo Nordisk Investigational Site
Anaheim, California, United States
Novo Nordisk Investigational Site
Greenbrae, California, United States
Novo Nordisk Investigational Site
San Diego, California, United States
Novo Nordisk Investigational Site
Spring Valley, California, United States
Novo Nordisk Investigational Site
Bradenton, Florida, United States
Novo Nordisk Investigational Site
Kissimmee, Florida, United States
Novo Nordisk Investigational Site
Plantation, Florida, United States
Novo Nordisk Investigational Site
Avon, Illinois, United States
Novo Nordisk Investigational Site
Crystal Lake, Illinois, United States
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States
Novo Nordisk Investigational Site
Slidell, Louisiana, United States
Novo Nordisk Investigational Site
Waltham, Massachusetts, United States
Novo Nordisk Investigational Site
Buckley, Michigan, United States
Novo Nordisk Investigational Site
Nashua, New Hampshire, 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
Albany, New York, United States
Novo Nordisk Investigational Site
Myrtle Beach, South Carolina, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Fort Worth, Texas, United States
Novo Nordisk Investigational Site
Olympia, Washington, United States
Novo Nordisk Investigational Site
Tacoma, Washington, United States
Novo Nordisk Investigational Site
Kenosha, Wisconsin, United States
Novo Nordisk Investigational Site
Algiers, , Algeria
Novo Nordisk Investigational Site
Oran, , Algeria
Novo Nordisk Investigational Site
Tizi Ouzou, , Algeria
Novo Nordisk Investigational Site
Erdmannhausen, , Germany
Novo Nordisk Investigational Site
Münster, , Germany
Novo Nordisk Investigational Site
Neuwied, , Germany
Novo Nordisk Investigational Site
Rehlingen-Siersburg, , Germany
Novo Nordisk Investigational Site
Saint Ingbert, , Germany
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, , Malaysia
Novo Nordisk Investigational Site
Kuala Selangor, , Malaysia
Novo Nordisk Investigational Site
Denizli, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Gaziantep, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Hatay, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Countries
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References
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Bebakar WM, Chaykin L, Herslov ML, Rasmussen S. Intensification of IDegAsp Twice Daily (Adding Insulin Aspart vs. Switching To Basal-Bolus): Exploratory Randomized Trial in Type 2 Diabetes. Diabetes Ther. 2017 Feb;8(1):197-205. doi: 10.1007/s13300-016-0213-8. Epub 2016 Nov 16.
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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2012-003152-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1132-2674
Identifier Type: OTHER
Identifier Source: secondary_id
NN5401-4003
Identifier Type: -
Identifier Source: org_study_id
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