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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01079234
First received: March 2, 2010
Last updated: December 16, 2016
Last verified: December 2016
  Purpose
This trial is conducted in Europe and in the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of NN1250 (insulin degludec) in subjects with type 1 diabetes.

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

Study Type: Interventional
Study Design: Allocation: Randomized
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 (Begin™: Flex T1)

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment [ Time Frame: Week 0, Week 26 ]
    Change from baseline in HbA1c after 26 weeks of treatment

  • Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 52 + 7 days follow up ]
    Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.

  • Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 52 + 7 days follow up ]
    Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.


Secondary Outcome Measures:
  • Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment [ Time Frame: Week 0, Week 52 ]
    Change from baseline in HbA1c after 52 weeks of treatment.

  • Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment [ Time Frame: Week 0, Week 26 ]
    Change from baseline in FPG after 26 weeks of treatment

  • Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment [ Time Frame: Week 0, Week 52 ]
    Change from baseline in FPG after 52 weeks of treatment.


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: Flex + insulin aspart Drug: insulin degludec
Injected subcutaneously (under the skin) once daily
Drug: insulin aspart
At least three daily doses at meal-time
Experimental: Fixed + insulin aspart Drug: insulin degludec
Injected subcutaneously (under the skin) once daily
Drug: insulin aspart
At least three daily doses at meal-time
Active Comparator: IGlar + insulin aspart Drug: insulin glargine
Insulin glargine 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   (Adult, Senior)
Sexes Eligible for Study:   All
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 (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:

  • Use within the last 3 months prior to Visit 1 of any antidiabetic glucose lowering drug other than insulin
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, California
Novo Nordisk Investigational Site
Encino, California, United States, 91436
Novo Nordisk Investigational Site
Fresno, California, United States, 93720
Novo Nordisk Investigational Site
Huntington Beach, California, United States, 92648
Novo Nordisk Investigational Site
Long Beach, California, United States, 90806
Novo Nordisk Investigational Site
Redondo Beach, California, United States, 90277
Novo Nordisk Investigational Site
Walnut Creek, California, United States, 94598
United States, Colorado
Novo Nordisk Investigational Site
Aurora, Colorado, United States, 80045
Novo Nordisk Investigational Site
Denver, Colorado, United States, 80209
United States, Florida
Novo Nordisk Investigational Site
DeLand, Florida, United States, 32720
Novo Nordisk Investigational Site
Hollywood, Florida, United States, 33021
Novo Nordisk Investigational Site
Miami, Florida, United States, 33136
United States, Georgia
Novo Nordisk Investigational Site
Lawrenceville, Georgia, United States, 30046
Novo Nordisk Investigational Site
Roswell, Georgia, United States, 30076
United States, Idaho
Novo Nordisk Investigational Site
Nampa, Idaho, United States, 83686-6011
United States, Illinois
Novo Nordisk Investigational Site
Crystal Lake, Illinois, United States, 60012
United States, Iowa
Novo Nordisk Investigational Site
Des Moines, Iowa, United States, 50314-2610
Novo Nordisk Investigational Site
Des Moines, Iowa, United States, 50314
United States, Maryland
Novo Nordisk Investigational Site
Baltimore, Maryland, United States, 21204
United States, Missouri
Novo Nordisk Investigational Site
Jefferson City, Missouri, United States, 65109
Novo Nordisk Investigational Site
Springfield, Missouri, United States, 65807
Novo Nordisk Investigational Site
St. Louis, Missouri, United States, 63141
United States, Nebraska
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68114
United States, New Hampshire
Novo Nordisk Investigational Site
Nashua, New Hampshire, United States, 03063
United States, New Jersey
Novo Nordisk Investigational Site
Flemington, New Jersey, United States, 08822-5763
United States, New York
Novo Nordisk Investigational Site
Smithtown, New York, United States, 11787
Novo Nordisk Investigational Site
Staten Island, New York, United States, 10301
United States, North Carolina
Novo Nordisk Investigational Site
Asheville, North Carolina, United States, 28803
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, United States, 27517
Novo Nordisk Investigational Site
Greenville, North Carolina, United States, 27834
Novo Nordisk Investigational Site
Morehead City, North Carolina, United States, 28557
United States, South Carolina
Novo Nordisk Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37411
Novo Nordisk Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Novo Nordisk Investigational Site
Arlington, Texas, United States, 76014
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75230
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75231
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75246
Novo Nordisk Investigational Site
Houston, Texas, United States, 77095
Novo Nordisk Investigational Site
Round Rock, Texas, United States, 78681
United States, Washington
Novo Nordisk Investigational Site
Spokane, Washington, United States, 99208
Belgium
Novo Nordisk Investigational Site
Aalst, Belgium, 9300
Novo Nordisk Investigational Site
Arlon, Belgium, 6700
Novo Nordisk Investigational Site
Bonheiden, Belgium, 2820
Novo Nordisk Investigational Site
Brussels, Belgium, 1070
Novo Nordisk Investigational Site
Leuven, Belgium, 3000
Germany
Novo Nordisk Investigational Site
Bad Kreuznach, Germany, 55545
Novo Nordisk Investigational Site
Falkensee, Germany, 14612
Novo Nordisk Investigational Site
Hamburg, Germany, 21073
Novo Nordisk Investigational Site
Hamburg, Germany, 22391
Novo Nordisk Investigational Site
Hamburg, Germany, 22607
Novo Nordisk Investigational Site
Hohenmölsen, Germany, 06679
Novo Nordisk Investigational Site
Rehburg-Loccum, Germany, 31547
Novo Nordisk Investigational Site
Rehlingen-Siersburg, Germany, 66780
Novo Nordisk Investigational Site
St. Ingbert, Germany, 66386
Novo Nordisk Investigational Site
Völklingen, Germany, 66333
Greece
Novo Nordisk Investigational Site
Athens, Greece, 151 23
Novo Nordisk Investigational Site
Athens, Greece, GR-10552
Novo Nordisk Investigational Site
Athens, Greece, GR-11527
Novo Nordisk Investigational Site
Thessaloniki, Greece, 54001
Novo Nordisk Investigational Site
Thessaloniki, Greece, GR-57001
Norway
Novo Nordisk Investigational Site
Bergen, Norway, 5021
Novo Nordisk Investigational Site
Elverum, Norway, 2408
Novo Nordisk Investigational Site
Hamar, Norway, 2317
Novo Nordisk Investigational Site
Kongsvinger, Norway, 2212
Novo Nordisk Investigational Site
Stavanger, Norway, 4011
Novo Nordisk Investigational Site
Ålesund, Norway, 6003
Poland
Novo Nordisk Investigational Site
Bialystok, Poland, 15-435
Novo Nordisk Investigational Site
Lublin, Poland, 20-538
Novo Nordisk Investigational Site
Poznan, Poland, 60-834
Novo Nordisk Investigational Site
Warszawa, Poland, 02-507
United Kingdom
Novo Nordisk Investigational Site
Belfast, United Kingdom, BT16 1RH
Novo Nordisk Investigational Site
Bristol, United Kingdom, BS10 5NB
Novo Nordisk Investigational Site
Guildford, United Kingdom, GU2 7XX
Novo Nordisk Investigational Site
Hull, United Kingdom, HU3 2JZ
Novo Nordisk Investigational Site
Inverness, United Kingdom, IV2 3JH
Novo Nordisk Investigational Site
Ipswich, United Kingdom, IP4 5PD
Novo Nordisk Investigational Site
Newcastle, United Kingdom, NE4 6BE
Novo Nordisk Investigational Site
Rugby, United Kingdom, CV22 5PX
Novo Nordisk Investigational Site
Southall, United Kingdom, UB1 3HW
Novo Nordisk Investigational Site
Stevenage, United Kingdom, SG1 4AB
Novo Nordisk Investigational Site
Swansea, United Kingdom, SA6 6NL
Novo Nordisk Investigational Site
Welwyn Garden City, United Kingdom, AL7 4HQ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01079234     History of Changes
Other Study ID Numbers: NN1250-3770
U1111-1112-8813 ( Other Identifier: WHO )
2009-012923-27 ( EudraCT Number )
Study First Received: March 2, 2010
Results First Received: October 12, 2015
Last Updated: December 16, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017