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Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01068678
First received: February 12, 2010
Last updated: January 20, 2017
Last verified: January 2017
  Purpose
This trial is conducted in Africa, Asia, Europe, and North America. The aim of this clinical trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes currently treated with metformin alone or with metformin combined with an oral anti-diabetic drug (OAD) qualifying for intensified treatment.

Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin degludec
Drug: insulin glargine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: EASY AM)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 26 ]
    Change from baseline in HbA1c after week 26


Secondary Outcome Measures:
  • Change in Body Weight [ Time Frame: Week 26 ]
    Change from baseline in body weight after week 26


Enrollment: 460
Study Start Date: February 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDeg 3 times weekly (3TW) Drug: insulin degludec
Injected subcutaneously (under the skin) three times weekly. Dose was individually adjusted.
Active Comparator: IGlar OD Drug: insulin glargine
Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Insulin naïve subject (allowed are: previous short term insulin treatment up to 14 days; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
  • Current treatment: metformin monotherapy or metformin in any combination with insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least three months prior to Visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination) 1500 mg daily or maximum tolerated dose (at least 1000 mg daily) -Insulin secretaguogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
  • HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
  • Body Mass Index (BMI) below or equal to 45.0 kg/m^2

Exclusion Criteria:

  • Use within the last 3 months prior to Visit 1 of: thiazoledinediones, exenatide or liraglutide
  • 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 at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for UK: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods)
  • Cancer and medical history of cancer hereof (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: NCT01068678

  Hide Study Locations
Locations
United States, California
Novo Nordisk Investigational Site
Northridge, California, United States, 91325
Novo Nordisk Investigational Site
Palm Springs, California, United States, 92262
Novo Nordisk Investigational Site
Paramount, California, United States, 90723
Novo Nordisk Investigational Site
Santa Ana, California, United States, 92704
Novo Nordisk Investigational Site
Spring Valley, California, United States, 91978
Novo Nordisk Investigational Site
Tustin, California, United States, 92780
United States, Florida
Novo Nordisk Investigational Site
Melbourne, Florida, United States, 32901
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30318
Novo Nordisk Investigational Site
Columbus, Georgia, United States, 31909
Novo Nordisk Investigational Site
Perry, Georgia, United States, 31069
United States, Illinois
Novo Nordisk Investigational Site
Olympia Fields, Illinois, United States, 60461
United States, Indiana
Novo Nordisk Investigational Site
Avon, Indiana, United States, 46123
Novo Nordisk Investigational Site
Fishers, Indiana, United States, 46038-1862
Novo Nordisk Investigational Site
Franklin, Indiana, United States, 46131-9121
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46254
Novo Nordisk Investigational Site
Muncie, Indiana, United States, 47304
United States, Iowa
Novo Nordisk Investigational Site
Des Moines, Iowa, United States, 50314
United States, Kentucky
Novo Nordisk Investigational Site
Lexington, Kentucky, United States, 40503
Novo Nordisk Investigational Site
Paducah, Kentucky, United States, 42003
United States, Maryland
Novo Nordisk Investigational Site
Hyattsville, Maryland, United States, 20782
Novo Nordisk Investigational Site
Rockville, Maryland, United States, 20852
United States, Michigan
Novo Nordisk Investigational Site
Interlochen, Michigan, United States, 49643
United States, Mississippi
Novo Nordisk Investigational Site
Jackson, Mississippi, United States, 39216
United States, Missouri
Novo Nordisk Investigational Site
Chesterfield, Missouri, United States, 63017
Novo Nordisk Investigational Site
St. Peters, Missouri, United States, 63376
United States, Montana
Novo Nordisk Investigational Site
Billings, Montana, United States, 59101
United States, Nebraska
Novo Nordisk Investigational Site
Lincoln, Nebraska, United States, 68521
United States, New Jersey
Novo Nordisk Investigational Site
Hamilton, New Jersey, United States, 08619
Novo Nordisk Investigational Site
Toms River, New Jersey, United States, 08755-8050
United States, New York
Novo Nordisk Investigational Site
Syracuse, New York, United States, 13210
Novo Nordisk Investigational Site
West Seneca, New York, United States, 14224
United States, North Carolina
Novo Nordisk Investigational Site
Durham, North Carolina, United States, 27710
Novo Nordisk Investigational Site
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Novo Nordisk Investigational Site
Canton, Ohio, United States, 44718
Novo Nordisk Investigational Site
Cleveland, Ohio, United States, 44115
Novo Nordisk Investigational Site
Dayton, Ohio, United States, 45439
Novo Nordisk Investigational Site
Mentor, Ohio, United States, 44060
United States, Pennsylvania
Novo Nordisk Investigational Site
Pottstown, Pennsylvania, United States, 19464
Novo Nordisk Investigational Site
Upper St.Clair, Pennsylvania, United States, 15241
United States, South Carolina
Novo Nordisk Investigational Site
Charleston, South Carolina, United States, 29455
Novo Nordisk Investigational Site
Greer, South Carolina, United States, 29651
Novo Nordisk Investigational Site
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
Novo Nordisk Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Novo Nordisk Investigational Site
Amarillo, Texas, United States, 79106
Novo Nordisk Investigational Site
Arlington, Texas, United States, 76014-2010
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75231
Novo Nordisk Investigational Site
Fort Worth, Texas, United States, 76113
Novo Nordisk Investigational Site
Houston, Texas, United States, 77074
Novo Nordisk Investigational Site
Houston, Texas, United States, 77095
Novo Nordisk Investigational Site
Irving, Texas, United States, 75061-2210
Novo Nordisk Investigational Site
Plano, Texas, United States, 75024
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78224
United States, Utah
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Virginia
Novo Nordisk Investigational Site
Fredericksburg, Virginia, United States, 22408-2674
Novo Nordisk Investigational Site
Richmond, Virginia, United States, 23225-4017
Novo Nordisk Investigational Site
Virginia Beach, Virginia, United States, 23462
United States, Wisconsin
Novo Nordisk Investigational Site
Menomonee Falls, Wisconsin, United States, 53051-4049
Canada, Alberta
Novo Nordisk Investigational Site
Calgary, Alberta, Canada, T3C 3P1
Novo Nordisk Investigational Site
Edmonton, Alberta, Canada, T5J 3N4
Canada, Manitoba
Novo Nordisk Investigational Site
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Newfoundland and Labrador
Novo Nordisk Investigational Site
St. John's, Newfoundland and Labrador, Canada, A1A 3R5
Canada, Nova Scotia
Novo Nordisk Investigational Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Novo Nordisk Investigational Site
London, Ontario, Canada, N6A 4V2
Novo Nordisk Investigational Site
Mississauga, Ontario, Canada, L5M 2V8
Novo Nordisk Investigational Site
Sarnia, Ontario, Canada, N7T 4X3
Novo Nordisk Investigational Site
Sudbury, Ontario, Canada, P3E 1Y8
Novo Nordisk Investigational Site
Toronto, Ontario, Canada, M3J 1N2
Novo Nordisk Investigational Site
Toronto, Ontario, Canada, M4N 3M5
Novo Nordisk Investigational Site
Toronto, Ontario, Canada, M4P 1P2
Canada, Quebec
Novo Nordisk Investigational Site
Mirabel, Quebec, Canada, J7J 2K8
Novo Nordisk Investigational Site
Sherbrooke, Quebec, Canada, J1G 5K2
Canada
Novo Nordisk Investigational Site
St John's, Canada, A1B 3V6
Czech Republic
Novo Nordisk Investigational Site
Brandys nad Labem, Czech Republic, 250 01
Novo Nordisk Investigational Site
Mlada Boleslav, Czech Republic, 293 50
Novo Nordisk Investigational Site
Ostrava, Czech Republic, 707 02
Novo Nordisk Investigational Site
Prague, Czech Republic, 120 00
Novo Nordisk Investigational Site
Trutnov, Czech Republic, 541 01
Israel
Novo Nordisk Investigational Site
Petah-Tikva, Israel, 49372
Novo Nordisk Investigational Site
Rehovot, Israel, 76100
Novo Nordisk Investigational Site
Rishon Le Zion, Israel, 75650
Novo Nordisk Investigational Site
Tel Hashomer, Israel, 52621
Novo Nordisk Investigational Site
Zefat, Israel, 13100
Puerto Rico
Novo Nordisk Investigational Site
Manati, Puerto Rico, 00674
Slovakia
Novo Nordisk Investigational Site
Bratislava, Slovakia, 811 08
Novo Nordisk Investigational Site
Kosice, Slovakia, 04-001
Novo Nordisk Investigational Site
Moldava nad Bodvou, Slovakia, 045 01
Novo Nordisk Investigational Site
Nove Zamky, Slovakia, 940 59
Novo Nordisk Investigational Site
Presov, Slovakia, 080 01
South Africa
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 2198
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4091
United Kingdom
Novo Nordisk Investigational Site
Aberdeen, United Kingdom, AB25 1LD
Novo Nordisk Investigational Site
Aldershot, United Kingdom, GU12 5BA
Novo Nordisk Investigational Site
Birmingham, United Kingdom, B9 5SS
Novo Nordisk Investigational Site
Chippenham, United Kingdom, SN15 2SB
Novo Nordisk Investigational Site
Exeter, United Kingdom, EX2 5AX
Novo Nordisk Investigational Site
Guildford, United Kingdom, GU2 7XX
Novo Nordisk Investigational Site
Nuneaton, United Kingdom, CV10 7DJ
Novo Nordisk Investigational Site
Portsmouth, United Kingdom, PO6 3LY
Novo Nordisk Investigational Site
Watford, United Kingdom, WD18 0HB
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01068678     History of Changes
Other Study ID Numbers: NN1250-3724
2009-011398-33 ( EudraCT Number )
U1111-1113-2412 ( Other Identifier: WHO )
Study First Received: February 12, 2010
Results First Received: October 12, 2015
Last Updated: January 20, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 28, 2017