Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes
NCT ID: NCT01045707
Last Updated: 2016-12-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
530 participants
INTERVENTIONAL
2010-01-31
2010-10-31
Brief Summary
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The main period is registered internally at Novo Nordisk as NN5401-3590 while the extension period is registered as NN5401-3726.
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 OD
insulin degludec/insulin aspart
Injected s.c. (under the skin) once daily with the breakfast meal. Dose was individually adjusted.
IGlar OD
insulin glargine
Injected s.c. (under the skin) once daily. Dose was individually adjusted.
Interventions
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insulin degludec/insulin aspart
Injected s.c. (under the skin) once daily with the breakfast meal. Dose was individually adjusted.
insulin glargine
Injected s.c. (under the skin) once daily. Dose was individually adjusted.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of type 2 diabetes mellitus for at least 6 months
* Insulin naïve subjects
* Treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start
* Glycosylated haemoglobin (HbA1c) between 7.5 - 11.0% (both inclusive)
* Body Mass Index (BMI) no higher than 40.0 kg/m\^2
* For EXTENSION period (NN5401-3726):
* Informed consent obtained before any trial-related activities
* Must have completed the 26-week treatment period (visit 28) in trial NN5401-3590
Exclusion Criteria
* Treatment with glucagon like peptide-1 (GLP-1) receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start
* Cardiovascular disease diagnosed within 6 months before trial start
* For EXTENSION period (NN5401-3726):
* Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, Monoamine oxidase (MAO) inhibitors
* Anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the physician)
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
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
Birmingham, Alabama, United States
Novo Nordisk Investigational Site
Vestavia Hills, Alabama, United States
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Concord, California, United States
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Greenbrae, California, United States
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Los Angeles, California, United States
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Waterbury, Connecticut, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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North Miami, Florida, United States
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Pembroke Pines, Florida, United States
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Honolulu, Hawaii, United States
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Honolulu, Hawaii, United States
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Idaho Falls, Idaho, United States
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Council Bluffs, Iowa, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Detroit, Michigan, United States
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Troy, Michigan, United States
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Saint Charles, Missouri, United States
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Springfield, Missouri, United States
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Brooklyn, New York, United States
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Smithtown, New York, United States
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Greensboro, North Carolina, United States
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Greenville, North Carolina, United States
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Morehead City, North Carolina, United States
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Wilson, North Carolina, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Greer, South Carolina, United States
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Chattanooga, Tennessee, United States
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Memphis, Tennessee, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Lubbock, Texas, United States
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San Antonio, Texas, United States
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Tomball, Texas, United States
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St. George, Utah, United States
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Newport News, Virginia, United States
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Olympia, Washington, United States
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Ebreichsdorf, , Austria
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Feldbach, , Austria
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Innsbruck, , Austria
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Salzburg, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Mumbai, Maharashtra, India
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Jaipur, Rajasthan, India
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Trichy, Tamil Nadu, India
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Bangalore, , India
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Kerala, , India
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Patna, , India
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Krakow, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Pruszków, , Poland
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Warsaw, , Poland
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Bayamón, , Puerto Rico
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Arkhangelsk, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Orenburg, , Russia
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Samara, , Russia
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Saratov, , Russia
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Saratov, , Russia
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Smolensk, , Russia
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Stavropol, , Russia
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Yaroslavl, , Russia
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Pucheon, , South Korea
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Pusan, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Málaga, , Spain
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Mérida, , Spain
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Palma de Mallorca, , Spain
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Partida de Bacarot, , Spain
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Pozuelo de Alarcón, , Spain
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San Sebastián de los Reyes, , Spain
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Santiago de Compostela, , Spain
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Seville, , Spain
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Valencia, , Spain
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Valladolid, , Spain
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Antalya, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Countries
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References
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Kumar A, Franek E, Wise J, Niemeyer M, Mersebach H, Simo R. Efficacy and Safety of Once-Daily Insulin Degludec/Insulin Aspart versus Insulin Glargine (U100) for 52 Weeks in Insulin-Naive Patients with Type 2 Diabetes: A Randomized Controlled Trial. PLoS One. 2016 Oct 19;11(10):e0163350. doi: 10.1371/journal.pone.0163350. eCollection 2016.
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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2009-011271-78
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1111-7178
Identifier Type: OTHER
Identifier Source: secondary_id
2009-015839-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1114-9237
Identifier Type: OTHER
Identifier Source: secondary_id
NN5401-3590
Identifier Type: -
Identifier Source: org_study_id
NCT01169766
Identifier Type: -
Identifier Source: nct_alias