Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine
NCT ID: NCT01680341
Last Updated: 2018-04-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
272 participants
INTERVENTIONAL
2012-08-31
2013-08-22
Brief Summary
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The aim of the trial is to compare the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes mellitus previously treated with insulin glargine.
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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 Simple
insulin degludec/insulin aspart
Twice weekly self-titration at intervals of 3-4 days, based upon a single pre-breakfast and pre-dinner SMPG (self-measured plasma glucose) value. For subcutaneous (s.c., under the skin) administration.
IDegAsp Step wise
insulin degludec/insulin aspart
Once weekly self-titration based upon the lowest of 3 pre-breakfast and 3 pre-dinner SMPG (self-measured plasma glucose) values. For subcutaneous (s.c., under the skin) administration.
Interventions
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insulin degludec/insulin aspart
Twice weekly self-titration at intervals of 3-4 days, based upon a single pre-breakfast and pre-dinner SMPG (self-measured plasma glucose) value. For subcutaneous (s.c., under the skin) administration.
insulin degludec/insulin aspart
Once weekly self-titration based upon the lowest of 3 pre-breakfast and 3 pre-dinner SMPG (self-measured plasma glucose) values. For subcutaneous (s.c., under the skin) administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently treated with IGlar (Insulin Glargine) and up to 3 oral antidiabetic drugs (OADs) (metformin, DPP-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase inhibitor). All antidiabetic treatments should have been ongoing for at least 12 weeks prior to Visit 2 (randomisation) and doses should have been stable in this period of time
* Glycosylated haemoglobin (HbA1c) 7.0-10.0% (both inclusive) by central laboratory analysis
* Body mass index (BMI) below or equal to 40 kg/m\^2
Exclusion Criteria
* Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 24 weeks prior to Visit 2 (randomisation)
* Uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator
* Life-threatening disease (e.g. 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
Goodyear, 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
St. Petersburg, Florida, United States
Novo Nordisk Investigational Site
Suwanee, Georgia, 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
Charleston, South Carolina, 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
Pohlheim, , Germany
Novo Nordisk Investigational Site
Rehlingen-Siersburg, , Germany
Novo Nordisk Investigational Site
Saint Ingbert, , Germany
Novo Nordisk Investigational Site
Cheras, , Malaysia
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, , Malaysia
Novo Nordisk Investigational Site
Kuala Selangor, , Malaysia
Novo Nordisk Investigational Site
Antalya, , Turkey (Türkiye)
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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Bode BW, Buse JB, Fisher M, Garg SK, Marre M, Merker L, Renard E, Russell-Jones DL, Hansen CT, Rana A, Heller SR; BEGIN(R) Basal-Bolus Type 1 trial investigators. Insulin degludec improves glycaemic control with lower nocturnal hypoglycaemia risk than insulin glargine in basal-bolus treatment with mealtime insulin aspart in Type 1 diabetes (BEGIN((R)) Basal-Bolus Type 1): 2-year results of a randomized clinical trial. Diabet Med. 2013 Nov;30(11):1293-7. doi: 10.1111/dme.12243. Epub 2013 Jun 17.
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.
Gerety G, Bebakar WM, Chaykin L, Ozkaya M, Macura S, Herslov ML, Behnke T. TREATMENT INTENSIFICATION WITH INSULIN DEGLUDEC/INSULIN ASPART TWICE DAILY: RANDOMIZED STUDY TO COMPARE SIMPLE AND STEP-WISE TITRATION ALGORITHMS. Endocr Pract. 2016 May;22(5):546-54. doi: 10.4158/EP15893.OR. Epub 2015 Dec 31.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2012-000373-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1127-4114
Identifier Type: OTHER
Identifier Source: secondary_id
NN5401-3941
Identifier Type: -
Identifier Source: org_study_id
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