Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes - Full Text View

Purpose

This trial is conducted in Europe and in the United States of America (USA). The aim of the trial is to investigate the efficacy and safety of NN1250 in subjects with type 1 diabetes.

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: NN1250 Drug: insulin glargine Drug: insulin aspart	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A 26-week Trial Investigating the Dosing Flexibility, Efficacy and Safety of NN1250 in Subjects With Type 1 Diabetes - With a 26 Week Extension

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 1

Drug Information available for: Insulin human Insulin aspart Insulin glargine

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in FPG (fasting plasma glucose) [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Hypoglycaemic episodes [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment:	493
Study Start Date:	March 2010
Study Completion Date:	May 2011
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: NN1250 NN1250 injected subcutaneously (under the skin) once daily (alternative regimens) Drug: insulin aspart At least three daily doses at meal-time
Active Comparator: B	Drug: insulin glargine Insulin glargine injected subcutaneously (under the skin) once daily Drug: insulin aspart At least three daily doses at meal-time
Experimental: C	Drug: NN1250 NN1250 injected subcutaneously (under the skin) once daily Drug: insulin aspart At least three daily doses at meal-time

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 1 diabetes for 12 months or longer, hereof the last 3 months with injection based therapies
Current treatment with any basal insulin using one or two daily injections and with three or more daily meal-time insulin injections used as bolus insulin therapy
HbA1c below or equal to 10.0 %
BMI (Body Mass Index) below or equal to 35.0 kg/m2
Ability to self-manage insulin therapy of a changed insulin dose in the preceding two months prior to trial entry
Ability and willingness to adhere to the protocol including performance of SMPG (self-measured plasma glucose) profiles and self-adjustment of insulin doses

Exclusion Criteria:

Use of any antidiabetic glucose lowering drug other than insulin within the last 3 months prior to trial entry
Cardiovascular disease within the last 6 months prior to trial entry
Uncontrolled treated/untreated severe hypertension
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
Cancer and medical history of cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079234

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Locations

United States, California
Novo Nordisk Clinical Trial Call Center
Encino, California, United States, 91436
Novo Nordisk Clinical Trial Call Center
Fresno, California, United States, 93720
Novo Nordisk Clinical Trial Call Center
Huntington Beach, California, United States, 92648
Novo Nordisk Clinical Trial Call Center
Walnut Creek, California, United States, 94598
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Aurora, Colorado, United States, 80045
Novo Nordisk Clinical Trial Call Center
Denver, Colorado, United States, 80209-3806
United States, Florida
Novo Nordisk Clinical Trial Call Center
DeLand, Florida, United States, 32720
Novo Nordisk Clinical Trial Call Center
Hollywood, Florida, United States, 33021
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33136
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Lawrenceville, Georgia, United States, 30046
Novo Nordisk Clinical Trial Call Center
Roswell, Georgia, United States, 30076
United States, Idaho
Novo Nordisk Clinical Trial Call Center
Nampa, Idaho, United States, 83686-6011
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Crystal Lake, Illinois, United States, 60012
United States, Iowa
Novo Nordisk Clinical Trial Call Center
Des Moines, Iowa, United States, 50314-2610
Novo Nordisk Clinical Trial Call Center
Des Moines, Iowa, United States, 50314
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Baltimore, Maryland, United States, 21204
United States, Missouri
Novo Nordisk Clinical Trial Call Center
St. Louis, Missouri, United States, 63141
United States, Nebraska
Novo Nordisk Clinical Trial Call Center
Omaha, Nebraska, United States, 68114
United States, New Hampshire
Novo Nordisk Clinical Trial Call Center
Nashua, New Hampshire, United States, 03063
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Flemington, New Jersey, United States, 08822-5763
United States, New York
Novo Nordisk Clinical Trial Call Center
Smithtown, New York, United States, 11787
Novo Nordisk Clinical Trial Call Center
Staten Island, New York, United States, 10301
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Asheville, North Carolina, United States, 28803
Novo Nordisk Clinical Trial Call Center
Durham, North Carolina, United States, 27713
Novo Nordisk Clinical Trial Call Center
Greenville, North Carolina, United States, 27834
Novo Nordisk Clinical Trial Call Center
Morehead City, North Carolina, United States, 28557
United States, South Carolina
Novo Nordisk Clinical Trial Call Center
Greer, South Carolina, United States, 29651
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Chattanooga, Tennessee, United States, 37411
Novo Nordisk Clinical Trial Call Center
Memphis, Tennessee, United States, 38119
United States, Texas
Novo Nordisk Clinical Trial Call Center
Arlington, Texas, United States, 76014
Novo Nordisk Clinical Trial Call Center
Austin, Texas, United States, 78731
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75230
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75246
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75231
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77095
Novo Nordisk Clinical Trial Call Center
Round Rock, Texas, United States, 78681
United States, Washington
Novo Nordisk Clinical Trial Call Center
Spokane, Washington, United States, 99208
Belgium

Aalst, Belgium, 9300
Germany

Rehburg-Loccum, Germany, 31547
Norway

Elverum, Norway, 2408
Poland

Krakow, Poland, 31-261
United Kingdom

Hull, United Kingdom, HU3 2JZ

London, United Kingdom, BT16 1RH

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Anette Skov Pedersen

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT01079234 History of Changes
Other Study ID Numbers:	NN1250-3770, U1111-1112-8813, 2009-012923-27
Study First Received:	March 2, 2010
Last Updated:	December 8, 2011
Health Authority:	Belgium: Federal Agency for Medicines and Health Products Germany: Federal Institute for Drugs and Medical Devices Norway: Norwegian Medicines Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration Poland: The Drug Institute in Warsaw Greece: Ministry of Health

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

Insulin aspart
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013

Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes (BEGIN™)