Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01046110
First received: January 8, 2010
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

This trial will be conducted in Africa, Asia, North America and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec) with sitagliptin, as add-on to subject's own current oral antidiabetic (OAD) treatment, in subjects with type 2 diabetes inadequately controlled with 1-2 OADs (metformin, sulphonylurea, glinides or pioglitazone).


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin degludec
Drug: sitagliptin
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 With Sitagliptin in Insulin Naive Subjects With Type 2 Diabetes (BEGIN™ : EARLY)

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 0, Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Fasting plasma glucose (FPG) [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]

Enrollment: 458
Study Start Date: January 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDeg OD Drug: insulin degludec
Injected under the skin once daily for 26 weeks. The doses will be individually adjusted.
Experimental: DPP-IV inhibitor Drug: sitagliptin
Sitagliptin tablets administered orally once a day at the same time every day for 26 weeks

  Eligibility

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

Inclusion Criteria:

  • Type 2 diabetes (diagnosed clinically) for at least 6 months
  • Ongoing treatment with 1 or 2 of the following OADs (metformin, insulin secretagogue (sulphonylurea or glinides) or pioglitazone) in any combination with unchanged dosing for at least 3 months prior to Visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination)1500 mg or maximum tolerated dose (at least 1000 mg daily) -Insulin secretagogue (sulfonylurea or glinide): minimum half of the maximal daily dose according to local labelling -Pioglitazone: minimum half of the maximal daily dose according to local labelling or maximum tolerated dose
  • Body Mass Index (BMI) below or equal to 40.0 kg/m^2
  • HbA1c 7.5-11.0 % (both inclusive) by central laboratory analysis

Exclusion Criteria:

  • Use within the last 3 months prior to Visit 1 of: exenatide, liraglutide, rosiglitazone or acarbose
  • 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)
  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
  • Cancer and medical history 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: NCT01046110

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Clinical Trial Call Center
Huntsville, Alabama, United States, 35801
United States, California
Novo Nordisk Clinical Trial Call Center
Concord, California, United States, 94520
Novo Nordisk Clinical Trial Call Center
Fresno, California, United States, 93720
Novo Nordisk Clinical Trial Call Center
Greenbrae, California, United States, 94904
Novo Nordisk Clinical Trial Call Center
La Jolla, California, United States, 92037
Novo Nordisk Clinical Trial Call Center
Mission Hills, California, United States, 91345
Novo Nordisk Clinical Trial Call Center
Palm Springs, California, United States, 92262-6972
Novo Nordisk Clinical Trial Call Center
Palm Springs, California, United States, 92262
Novo Nordisk Clinical Trial Call Center
Torrance, California, United States, 90504
Novo Nordisk Clinical Trial Call Center
Walnut Creek, California, United States, 94598
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Denver, Colorado, United States, 80239-3133
United States, Florida
Novo Nordisk Clinical Trial Call Center
Clearwater, Florida, United States, 33765
Novo Nordisk Clinical Trial Call Center
Inverness, Florida, United States, 34452
Novo Nordisk Clinical Trial Call Center
Kissimmee, Florida, United States, 34741
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33135-1687
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33125-1655
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33186
Novo Nordisk Clinical Trial Call Center
Ocala, Florida, United States, 34471
Novo Nordisk Clinical Trial Call Center
Ponte Vedra, Florida, United States, 32081
Novo Nordisk Clinical Trial Call Center
Tampa, Florida, United States, 33603
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Decatur, Georgia, United States, 30033
Novo Nordisk Clinical Trial Call Center
Roswell, Georgia, United States, 30076
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60624
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60611
Novo Nordisk Clinical Trial Call Center
Springfield, Illinois, United States, 62704
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Huntington, Indiana, United States, 46750-1404
United States, Iowa
Novo Nordisk Clinical Trial Call Center
Council Bluffs, Iowa, United States, 51501-3605
Novo Nordisk Clinical Trial Call Center
Des Moines, Iowa, United States, 50314-2610
United States, Kentucky
Novo Nordisk Clinical Trial Call Center
Paducah, Kentucky, United States, 42003
United States, Louisiana
Novo Nordisk Clinical Trial Call Center
Metairie, Louisiana, United States, 70002
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Livonia, Michigan, United States, 48152-3501
Novo Nordisk Clinical Trial Call Center
Troy, Michigan, United States, 48085-5524
United States, Mississippi
Novo Nordisk Clinical Trial Call Center
Jackson, Mississippi, United States, 39216
United States, New Mexico
Novo Nordisk Clinical Trial Call Center
Albuquerque, New Mexico, United States, 87108
United States, New York
Novo Nordisk Clinical Trial Call Center
West Seneca, New York, United States, 14224
United States, Oklahoma
Novo Nordisk Clinical Trial Call Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Pittsburgh, Pennsylvania, United States, 15224-2215
United States, South Carolina
Novo Nordisk Clinical Trial Call Center
Charleston, South Carolina, United States, 29401
United States, Texas
Novo Nordisk Clinical Trial Call Center
Corpus Christi, Texas, United States, 78404
Novo Nordisk Clinical Trial Call Center
El Paso, Texas, United States, 79905-2709
Novo Nordisk Clinical Trial Call Center
El Paso, Texas, United States, 79925
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77070
Novo Nordisk Clinical Trial Call Center
Sugar Land, Texas, United States, 77478
Novo Nordisk Clinical Trial Call Center
Sugarland, Texas, United States, 77478
Novo Nordisk Clinical Trial Call Center
Tomball, Texas, United States, 77375
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Virginia Beach, Virginia, United States, 23454
United States, Washington
Novo Nordisk Clinical Trial Call Center
Spokane, Washington, United States, 99208
Argentina
Buenos Aires, Argentina, C1449AAD
Canada, British Columbia
Surrey, British Columbia, Canada, V3S 2N6
India
Bangalore, Karnataka, India, 560 003
Mexico
Mexico City, Mexico, 11850
South Africa
Umhlanga, South Africa, 4320
Turkey
Denizli, Turkey, 20070
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Marianne Willert Novo Nordisk A/S
Study Director: Anne Engstrøm Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01046110     History of Changes
Other Study ID Numbers: NN1250-3580, U1111-1111-7126
Study First Received: January 8, 2010
Last Updated: March 26, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
Canada: Health Canada
India: Drugs Controller General of India
Mexico: Federal Commission for Protection Against Health Risks
South Africa: Medicines Control Council
Turkey: Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014