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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01046110
First Posted: January 11, 2010
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    Change from baseline in HbA1c after 26 weeks of treatment


Secondary Outcome Measures:
  • Change in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, Week 26 ]
    Change from baseline in FPG after 26 weeks of treatment


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046110


  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Investigational Site
Huntsville, Alabama, United States, 35801
United States, California
Novo Nordisk Investigational Site
Concord, California, United States, 94520
Novo Nordisk Investigational Site
Fresno, California, United States, 93720
Novo Nordisk Investigational Site
Greenbrae, California, United States, 94904
Novo Nordisk Investigational Site
La Jolla, California, United States, 92037
Novo Nordisk Investigational Site
Long Beach, California, United States, 90806
Novo Nordisk Investigational Site
Mission Hills, California, United States, 91345
Novo Nordisk Investigational Site
Palm Springs, California, United States, 92262
Novo Nordisk Investigational Site
Torrance, California, United States, 90504
Novo Nordisk Investigational Site
Walnut Creek, California, United States, 94598-3347
United States, Colorado
Novo Nordisk Investigational Site
Denver, Colorado, United States, 80239-3133
United States, Florida
Novo Nordisk Investigational Site
Clearwater, Florida, United States, 33765
Novo Nordisk Investigational Site
Inverness, Florida, United States, 34452
Novo Nordisk Investigational Site
Kissimmee, Florida, United States, 34741
Novo Nordisk Investigational Site
Miami, Florida, United States, 33125-1655
Novo Nordisk Investigational Site
Miami, Florida, United States, 33135
Novo Nordisk Investigational Site
Miami, Florida, United States, 33186
Novo Nordisk Investigational Site
Ocala, Florida, United States, 34471
Novo Nordisk Investigational Site
Ponte Vedra, Florida, United States, 32081
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33603
United States, Georgia
Novo Nordisk Investigational Site
Columbus, Georgia, United States, 31904
Novo Nordisk Investigational Site
Decatur, Georgia, United States, 30033
Novo Nordisk Investigational Site
Dunwoody, Georgia, United States, 30338
Novo Nordisk Investigational Site
Roswell, Georgia, United States, 30076
United States, Illinois
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60611
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60624
Novo Nordisk Investigational Site
Springfield, Illinois, United States, 62711
United States, Indiana
Novo Nordisk Investigational Site
Huntington, Indiana, United States, 46750-1404
United States, Iowa
Novo Nordisk Investigational Site
Council Bluffs, Iowa, United States, 51501
Novo Nordisk Investigational Site
Des Moines, Iowa, United States, 50314-2610
United States, Kentucky
Novo Nordisk Investigational Site
Paducah, Kentucky, United States, 42003
United States, Louisiana
Novo Nordisk Investigational Site
Metairie, Louisiana, United States, 70002
United States, Massachusetts
Novo Nordisk Investigational Site
Brockton, Massachusetts, United States, 02301
United States, Michigan
Novo Nordisk Investigational Site
Livonia, Michigan, United States, 48152-3501
Novo Nordisk Investigational Site
Troy, Michigan, United States, 48085-5524
United States, Minnesota
Novo Nordisk Investigational Site
St. Paul, Minnesota, United States, 55108
United States, Mississippi
Novo Nordisk Investigational Site
Jackson, Mississippi, United States, 39216
United States, New Mexico
Novo Nordisk Investigational Site
Albuquerque, New Mexico, United States, 87108
Novo Nordisk Investigational Site
Albuquerque, New Mexico, United States, 87131
United States, New York
Novo Nordisk Investigational Site
New Hyde Park, New York, United States, 11042
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
Greenville, North Carolina, United States, 27834-5784
United States, Oklahoma
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States, 15224-2215
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
United States, South Carolina
Novo Nordisk Investigational Site
Charleston, South Carolina, United States, 29401
Novo Nordisk Investigational Site
Murrells Inlet, South Carolina, United States, 29576
United States, Texas
Novo Nordisk Investigational Site
Corpus Christi, Texas, United States, 78404
Novo Nordisk Investigational Site
El Paso, Texas, United States, 79905-2709
Novo Nordisk Investigational Site
El Paso, Texas, United States, 79912
Novo Nordisk Investigational Site
Houston, Texas, United States, 77070
Novo Nordisk Investigational Site
Sugar Land, Texas, United States, 77478
Novo Nordisk Investigational Site
Tomball, Texas, United States, 77375
United States, Utah
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Virginia
Novo Nordisk Investigational Site
Virginia Beach, Virginia, United States, 23454
United States, Washington
Novo Nordisk Investigational Site
Spokane, Washington, United States, 99208
Argentina
Novo Nordisk Investigational Site
Buenos Aires, Argentina, C1181ACH
Novo Nordisk Investigational Site
Caba, Argentina, C1440AAD
Novo Nordisk Investigational Site
Ciudad Autónoma de BsAs, Argentina, C1406FWY
Novo Nordisk Investigational Site
Córdoba, Argentina, 5000
Novo Nordisk Investigational Site
Mar del Plata, Argentina, B7602CBM
Novo Nordisk Investigational Site
Mendoza, Argentina, 5500
Canada, British Columbia
Novo Nordisk Investigational Site
Surrey, British Columbia, Canada, V3S 2N6
Canada, Ontario
Novo Nordisk Investigational Site
Cambridge, Ontario, Canada, N1R 7L6
Novo Nordisk Investigational Site
Chatham, Ontario, Canada, N7L 1C1
Novo Nordisk Investigational Site
London, Ontario, Canada, N6H 4P2
Novo Nordisk Investigational Site
London, Ontario, Canada, N6P 1A9
Novo Nordisk Investigational Site
Smiths Falls, Ontario, Canada, K7A 4W8
Novo Nordisk Investigational Site
St.Catharines, Ontario, Canada, L2N 7H8
Canada, Quebec
Novo Nordisk Investigational Site
Gatineau, Quebec, Canada, J8V 2P5
Novo Nordisk Investigational Site
Laval, Quebec, Canada, H7T 2P5
Novo Nordisk Investigational Site
Montreal, Quebec, Canada, H3J 2V5
Novo Nordisk Investigational Site
St-Marc-des-Carrières, Quebec, Canada, G0A 4B0
India
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India, 500 001
Novo Nordisk Investigational Site
Bangalore, Karnataka, India, 560 003
Novo Nordisk Investigational Site
Bangalore, Karnataka, India, BANGALORE
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400008
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India, 600029
Novo Nordisk Investigational Site
Madurai, Tamil Nadu, India, 625 020
Novo Nordisk Investigational Site
Nagpur, India, 440012
Novo Nordisk Investigational Site
Pune, India, 411005
Novo Nordisk Investigational Site
Pune, India, 411011
Mexico
Novo Nordisk Investigational Site
Guadalajara, Mexico, 44600
Novo Nordisk Investigational Site
Mexico City, Mexico, 11850
South Africa
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4001
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa, 7460
Novo Nordisk Investigational Site
Umhlanga, South Africa, 4320
Turkey
Novo Nordisk Investigational Site
Ankara, Turkey, 06100
Novo Nordisk Investigational Site
Denizli, Turkey, 20070
Novo Nordisk Investigational Site
Istanbul, Turkey, 34098
Novo Nordisk Investigational Site
Istanbul, Turkey, 34390
Novo Nordisk Investigational Site
Izmir, Turkey, 35340
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: NCT01046110     History of Changes
Other Study ID Numbers: NN1250-3580
U1111-1111-7126 ( Other Identifier: WHO )
First Submitted: January 8, 2010
First Posted: January 11, 2010
Results First Submitted: October 19, 2015
Results First Posted: November 18, 2015
Last Update Posted: March 3, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action