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: November 26, 2013
Last verified: November 2013
  Purpose

This trial is conducted in Africa, Asia, Europe, and North America. The aim of this clinical trial is to compare the safety and efficacy 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Body Weight [ Time Frame: Week 26 ] [ Designated as safety issue: No ]

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 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
Genders Eligible for Study:   Both
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 Clinical Trial Call Center
Northridge, California, United States, 91325
Novo Nordisk Clinical Trial Call Center
Santa Ana, California, United States, 92704
Novo Nordisk Clinical Trial Call Center
Spring Valley, California, United States, 91978
Novo Nordisk Clinical Trial Call Center
Tustin, California, United States, 92780
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Atlanta, Georgia, United States, 30318
Novo Nordisk Clinical Trial Call Center
Columbus, Georgia, United States, 31909-1692
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Avon, Indiana, United States, 46123-7877
Novo Nordisk Clinical Trial Call Center
Fishers, Indiana, United States, 46038-1862
Novo Nordisk Clinical Trial Call Center
Franklin, Indiana, United States, 46131-9121
Novo Nordisk Clinical Trial Call Center
Indianapolis, Indiana, United States, 46254
Novo Nordisk Clinical Trial Call Center
Muncie, Indiana, United States, 47304
United States, Iowa
Novo Nordisk Clinical Trial Call Center
Des Moines, Iowa, United States, 50314
United States, Kentucky
Novo Nordisk Clinical Trial Call Center
Lexington, Kentucky, United States, 40503
Novo Nordisk Clinical Trial Call Center
Paducah, Kentucky, United States, 42003
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Hyattsville, Maryland, United States, 20782
Novo Nordisk Clinical Trial Call Center
Rockville, Maryland, United States, 20852
United States, Mississippi
Novo Nordisk Clinical Trial Call Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Novo Nordisk Clinical Trial Call Center
Chesterfield, Missouri, United States, 63017
Novo Nordisk Clinical Trial Call Center
St. Peters, Missouri, United States, 63376
United States, Montana
Novo Nordisk Clinical Trial Call Center
Billings, Montana, United States, 59101
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Toms River, New Jersey, United States, 08755-8050
United States, New York
Novo Nordisk Clinical Trial Call Center
Syracuse, New York, United States, 13210
Novo Nordisk Clinical Trial Call Center
West Seneca, New York, United States, 14224
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Durham, North Carolina, United States, 27710
Novo Nordisk Clinical Trial Call Center
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Canton, Ohio, United States, 44718
Novo Nordisk Clinical Trial Call Center
Dayton, Ohio, United States, 45439
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Pittsburgh, Pennsylvania, United States, 15241
United States, South Carolina
Novo Nordisk Clinical Trial Call Center
Charleston, South Carolina, United States, 29425-6240
Novo Nordisk Clinical Trial Call Center
Greer, South Carolina, United States, 29651
Novo Nordisk Clinical Trial Call Center
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Brentwood, Tennessee, United States, 37027
United States, Texas
Novo Nordisk Clinical Trial Call Center
Amarillo, Texas, United States, 79106
Novo Nordisk Clinical Trial Call Center
Arlington, Texas, United States, 76014-2010
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75231
Novo Nordisk Clinical Trial Call Center
Fort Worth, Texas, United States, 76113
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77074
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77095
Novo Nordisk Clinical Trial Call Center
Irving, Texas, United States, 75061-2210
Novo Nordisk Clinical Trial Call Center
Plano, Texas, United States, 75024
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78224
United States, Utah
Novo Nordisk Clinical Trial Call Center
Salt Lake City, Utah, United States, 84107
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Fredericksburg, Virginia, United States, 22408-2674
Novo Nordisk Clinical Trial Call Center
Richmond, Virginia, United States, 23225-4017
Novo Nordisk Clinical Trial Call Center
Virginia Beach, Virginia, United States, 23462
United States, Wisconsin
Novo Nordisk Clinical Trial Call Center
Menomonee Falls, Wisconsin, United States, 53051-4049
Canada, Alberta
Edmonton, Alberta, Canada, T5J 3N4
Czech Republic
Mlada Boleslav, Czech Republic, 293 50
Israel
Zefat, Israel, 13100
Slovakia
Bratislava, Slovakia, 811 08
South Africa
Johannesburg, Gauteng, South Africa, 2198
United Kingdom
Aberdeen, United Kingdom, AB25 1LD
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01068678     History of Changes
Other Study ID Numbers: NN1250-3724, 2009-011398-33, U1111-1113-2412
Study First Received: February 12, 2010
Last Updated: November 26, 2013
Health Authority: Canada: Health Canada
Czech Republic: State Institute for Drug Control
Israel: Ministry of Health
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014