Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes
NCT ID: NCT01079234
Last Updated: 2017-02-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
493 participants
INTERVENTIONAL
2010-03-31
2011-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics
NCT01002768
Comparison of NN1250 With Insulin Glargine in Type 2 Diabetes
NCT01006291
A Trial Evaluating the Effect of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes
NCT01114542
A Trial Investigating the Within-subject Variability of NN1250 in Subjects With Type 1 Diabetes
NCT00961324
Comparison of NN1250 Plus Insulin Aspart With Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes
NCT00982228
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Flex + insulin aspart
insulin degludec
Injected subcutaneously (under the skin) once daily
insulin aspart
At least three daily doses at meal-time
Fixed + insulin aspart
insulin degludec
Injected subcutaneously (under the skin) once daily
insulin aspart
At least three daily doses at meal-time
IGlar + insulin aspart
insulin glargine
Insulin glargine injected subcutaneously (under the skin) once daily
insulin aspart
At least three daily doses at meal-time
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
insulin degludec
Injected subcutaneously (under the skin) once daily
insulin glargine
Insulin glargine injected subcutaneously (under the skin) once daily
insulin aspart
At least three daily doses at meal-time
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Current treatment with any basal insulin (e.g. insulin glargine, insulin detemir, NPH insulin) using one or two daily injections and with three or more daily meal-time insulin injections (e.g. insulin aspart, insulin lispro, insulin glulisine, human insulin) used as bolus insulin therapy
* HbA1c maximum 10.0 % by central laboratory analysis
* Body Mass Index (BMI) below or equal to 35.0 kg/m\^2
* Ability to self-manage insulin therapy as assessed by confirmation (verbal confirmation at screening visit) of a changed insulin dose in the preceding two months prior to screening
* Ability and willingness to adhere to the protocol including performance of self measured plasma glucose (SMPG) profiles and self adjustment of insulin doses
Exclusion Criteria
* Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
* Uncontrolled treated/ untreated severe hypertension (systolic blood pressure above or equal to 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure above or equal to 100 mmHg)
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
* Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novo Nordisk A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novo Nordisk Investigational Site
Encino, California, United States
Novo Nordisk Investigational Site
Fresno, California, United States
Novo Nordisk Investigational Site
Huntington Beach, California, United States
Novo Nordisk Investigational Site
Long Beach, California, United States
Novo Nordisk Investigational Site
Redondo Beach, California, United States
Novo Nordisk Investigational Site
Walnut Creek, California, United States
Novo Nordisk Investigational Site
Aurora, Colorado, United States
Novo Nordisk Investigational Site
Denver, Colorado, United States
Novo Nordisk Investigational Site
DeLand, Florida, United States
Novo Nordisk Investigational Site
Hollywood, Florida, United States
Novo Nordisk Investigational Site
Miami, Florida, United States
Novo Nordisk Investigational Site
Lawrenceville, Georgia, United States
Novo Nordisk Investigational Site
Roswell, Georgia, United States
Novo Nordisk Investigational Site
Nampa, Idaho, United States
Novo Nordisk Investigational Site
Crystal Lake, Illinois, United States
Novo Nordisk Investigational Site
Des Moines, Iowa, United States
Novo Nordisk Investigational Site
Des Moines, Iowa, United States
Novo Nordisk Investigational Site
Baltimore, Maryland, United States
Novo Nordisk Investigational Site
Jefferson City, Missouri, United States
Novo Nordisk Investigational Site
Springfield, Missouri, United States
Novo Nordisk Investigational Site
St Louis, Missouri, United States
Novo Nordisk Investigational Site
Omaha, Nebraska, United States
Novo Nordisk Investigational Site
Nashua, New Hampshire, United States
Novo Nordisk Investigational Site
Flemington, New Jersey, United States
Novo Nordisk Investigational Site
Smithtown, New York, United States
Novo Nordisk Investigational Site
Staten Island, New York, United States
Novo Nordisk Investigational Site
Asheville, North Carolina, United States
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, United States
Novo Nordisk Investigational Site
Greenville, North Carolina, United States
Novo Nordisk Investigational Site
Morehead City, North Carolina, United States
Novo Nordisk Investigational Site
Greer, South Carolina, United States
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States
Novo Nordisk Investigational Site
Memphis, Tennessee, United States
Novo Nordisk Investigational Site
Arlington, Texas, United States
Novo Nordisk Investigational Site
Dallas, 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
Spokane, Washington, United States
Novo Nordisk Investigational Site
Aalst, , Belgium
Novo Nordisk Investigational Site
Arlon, , Belgium
Novo Nordisk Investigational Site
Bonheiden, , Belgium
Novo Nordisk Investigational Site
Brussels, , Belgium
Novo Nordisk Investigational Site
Leuven, , Belgium
Novo Nordisk Investigational Site
Bad Kreuznach, , Germany
Novo Nordisk Investigational Site
Falkensee, , Germany
Novo Nordisk Investigational Site
Hamburg, , Germany
Novo Nordisk Investigational Site
Hamburg, , Germany
Novo Nordisk Investigational Site
Hamburg, , Germany
Novo Nordisk Investigational Site
Hohenmölsen, , Germany
Novo Nordisk Investigational Site
Rehburg-Loccum, , Germany
Novo Nordisk Investigational Site
Rehlingen-Siersburg, , Germany
Novo Nordisk Investigational Site
Saint Ingbert, , Germany
Novo Nordisk Investigational Site
Völklingen, , Germany
Novo Nordisk Investigational Site
Athens, , Greece
Novo Nordisk Investigational Site
Athens, , Greece
Novo Nordisk Investigational Site
Athens, , Greece
Novo Nordisk Investigational Site
Thessaloniki, , Greece
Novo Nordisk Investigational Site
Thessaloniki, , Greece
Novo Nordisk Investigational Site
Ålesund, , Norway
Novo Nordisk Investigational Site
Bergen, , Norway
Novo Nordisk Investigational Site
Elverum, , Norway
Novo Nordisk Investigational Site
Hamar, , Norway
Novo Nordisk Investigational Site
Kongsvinger, , Norway
Novo Nordisk Investigational Site
Stavanger, , Norway
Novo Nordisk Investigational Site
Bialystok, , Poland
Novo Nordisk Investigational Site
Lublin, , Poland
Novo Nordisk Investigational Site
Poznan, , Poland
Novo Nordisk Investigational Site
Warsaw, , Poland
Novo Nordisk Investigational Site
Belfast, , United Kingdom
Novo Nordisk Investigational Site
Bristol, , United Kingdom
Novo Nordisk Investigational Site
Guildford, , United Kingdom
Novo Nordisk Investigational Site
Hull, , United Kingdom
Novo Nordisk Investigational Site
Inverness, , United Kingdom
Novo Nordisk Investigational Site
Ipswich, , United Kingdom
Novo Nordisk Investigational Site
Newcastle, , United Kingdom
Novo Nordisk Investigational Site
Rugby, , United Kingdom
Novo Nordisk Investigational Site
Southall, , United Kingdom
Novo Nordisk Investigational Site
Stevenage, , United Kingdom
Novo Nordisk Investigational Site
Swansea, , United Kingdom
Novo Nordisk Investigational Site
Welwyn Garden City, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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, Seufert J, Solberg H, Kinduryte O, Johansen T, Hollander P. Insulin degludec does not increase antibody formation versus insulin glargine: an evaluation of phase IIIa trials. Diabetes Obes Metab. 2016 Jul;18(7):716-20. doi: 10.1111/dom.12621. Epub 2016 Feb 8.
Mathieu C, Hollander P, Miranda-Palma B, Cooper J, Franek E, Russell-Jones D, Larsen J, Tamer SC, Bain SC; NN1250-3770 (BEGIN: Flex T1) Trial Investigators. Efficacy and safety of insulin degludec in a flexible dosing regimen vs insulin glargine in patients with type 1 diabetes (BEGIN: Flex T1): a 26-week randomized, treat-to-target trial with a 26-week extension. J Clin Endocrinol Metab. 2013 Mar;98(3):1154-62. doi: 10.1210/jc.2012-3249. Epub 2013 Feb 7.
Related Links
Access external resources that provide additional context or updates about the study.
Clinical Trials at Novo Nordisk
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1112-8813
Identifier Type: OTHER
Identifier Source: secondary_id
2009-012923-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN1250-3770
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.