Comparison of NN1250 Plus Insulin Aspart With Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes
NCT ID: NCT00982228
Last Updated: 2017-04-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
629 participants
INTERVENTIONAL
2009-09-01
2010-11-08
Brief Summary
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The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes.
The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension period is registered as NN1250-3644.
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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
insulin degludec
Injected subcutaneously once daily. Dose was individually adjusted.
insulin aspart
Injected subcutaneously as mealtime insulin. Dose was individually adjusted.
IGlar OD
insulin glargine
Injected subcutaneously once daily. Dose individually adjusted.
insulin aspart
Injected subcutaneously as mealtime insulin. Dose was individually adjusted.
Interventions
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insulin degludec
Injected subcutaneously once daily. Dose was individually adjusted.
insulin glargine
Injected subcutaneously once daily. Dose individually adjusted.
insulin aspart
Injected subcutaneously as mealtime insulin. Dose was individually adjusted.
Eligibility Criteria
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Inclusion Criteria
* Current treatment with any basal bolus insulin for at least 12 months
* HbA1c below or equal to 10.0%
* BMI (Body Mass Index) below or equal to 35.0 kg/m\^2
* For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3583 (NCT00982228)
Exclusion Criteria
* Cardiovascular disease within the last 6 months
* Uncontrolled treated/untreated severe hypertension
* Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
* Cancer and medical history of 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
Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Peoria, Arizona, United States
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Concord, California, United States
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Fresno, California, United States
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Greenbrae, California, United States
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Huntington Beach, California, United States
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La Mesa, California, United States
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Los Gatos, California, United States
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Santa Barbara, California, United States
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Tustin, California, United States
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Ventura, California, United States
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Walnut Creek, California, United States
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Aurora, Colorado, United States
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Aurora, Colorado, United States
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Hollywood, Florida, United States
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Lake Mary, Florida, United States
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Miami, Florida, United States
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Atlanta, Georgia, United States
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Lawrenceville, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Vincennes, Indiana, United States
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Lexington, Kentucky, United States
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Lexington, Kentucky, United States
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Scarborough, Maine, United States
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Hyattsville, Maryland, United States
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Rockville, Maryland, United States
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Brockton, Massachusetts, United States
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Flint, Michigan, United States
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Livonia, Michigan, United States
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Eagan, Minnesota, United States
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Chesterfield, Missouri, United States
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Jefferson City, Missouri, United States
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Saint Charles, Missouri, United States
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Great Falls, Montana, United States
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Omaha, Nebraska, United States
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Omaha, Nebraska, United States
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Dover, New Hampshire, United States
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Lawrenceville, New Jersey, United States
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Flushing, New York, United States
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Rochester, New York, United States
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Chapel Hill, North Carolina, United States
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Raleigh, North Carolina, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Rapid City, South Dakota, United States
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Chattanooga, Tennessee, United States
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Chattanooga, Tennessee, United States
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Dallas, Texas, 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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Round Rock, Texas, United States
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St. George, Utah, United States
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Renton, Washington, United States
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Milwaukee, Wisconsin, United States
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Boisguillaume, , France
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Brest, , France
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Grenoble, , France
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La Rochelle, , France
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Montpellier, , France
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Nice, , France
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Paris, , France
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Aschaffenburg, , Germany
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Bad Kreuznach, , Germany
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Dormagen, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Saint Ingbert, , Germany
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Saint Petersburg, , Russia
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Saint-Peterburg, , Russia
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Tyumen, , Russia
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Yaroslavl, , Russia
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Johannesburg, Gauteng, South Africa
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Cape Town, Western Cape, South Africa
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Cape Town, Western Cape, South Africa
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Aberdeen, , United Kingdom
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Birmingham, , United Kingdom
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Bradford, , United Kingdom
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Glasgow, , United Kingdom
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Guildford, , United Kingdom
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Leeds, , United Kingdom
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Llantrisant, , United Kingdom
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Sheffield, , 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.
Heller S, Mathieu C, Kapur R, Wolden ML, Zinman B. A meta-analysis of rate ratios for nocturnal confirmed hypoglycaemia with insulin degludec vs. insulin glargine using different definitions for hypoglycaemia. Diabet Med. 2016 Apr;33(4):478-87. doi: 10.1111/dme.13002. Epub 2015 Dec 13.
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, Christensen T, Rana A, Bain SC. Insulin degludec versus insulin glargine in type 1 and type 2 diabetes mellitus: a meta-analysis of endpoints in phase 3a trials. Diabetes Ther. 2014 Dec;5(2):435-46. doi: 10.1007/s13300-014-0076-9. Epub 2014 Aug 1.
Aye MM, Atkin SL. Patient safety and minimizing risk with insulin administration - role of insulin degludec. Drug Healthc Patient Saf. 2014 Apr 30;6:55-67. doi: 10.2147/DHPS.S59566. eCollection 2014.
Heller S, Buse J, Fisher M, Garg S, Marre M, Merker L, Renard E, Russell-Jones D, Philotheou A, Francisco AM, Pei H, Bode B; BEGIN Basal-Bolus Type 1 Trial Investigators. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet. 2012 Apr 21;379(9825):1489-97. doi: 10.1016/S0140-6736(12)60204-9.
Evans M, Chubb B, Gundgaard J. Cost-effectiveness of Insulin Degludec Versus Insulin Glargine in Adults with Type 1 and Type 2 Diabetes Mellitus. Diabetes Ther. 2017 Apr;8(2):275-291. doi: 10.1007/s13300-017-0236-9. Epub 2017 Feb 16.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2008-005774-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1111-8789
Identifier Type: OTHER
Identifier Source: secondary_id
2009-015755-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1116-1578
Identifier Type: OTHER
Identifier Source: secondary_id
NN1250-3583
Identifier Type: -
Identifier Source: org_study_id
NCT01198041
Identifier Type: -
Identifier Source: nct_alias
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