Comparison of Two Insulin Degludec Formulations in Subjects With Type 2 Diabetes Mellitus (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01364428
First received: May 31, 2011
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy and safety of two different formulations of insulin degludec (IDeg) in subjects with type 2 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin degludec
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 the Efficacy and Safety of Insulin Degludec 200 U/mL and Insulin Degludec 100 U/mL in Subjects With Type 2 Diabetes Mellitus (BEGIN™: COMPARE)

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 22 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, Week 22 ] [ Designated as safety issue: No ]
  • Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 22 + 7 days follow up ] [ Designated as safety issue: No ]
  • Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 22 + 7 days follow up ] [ Designated as safety issue: No ]
  • Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 22 + 7 days follow up ] [ Designated as safety issue: No ]

Enrollment: 373
Study Start Date: June 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDeg Drug: insulin degludec

Injected subcutaneously (under the skin) once daily, in combination with unchanged pre-trial oral anti-diabetic drug (OAD) treatment.

Dose was individually adjusted.

Experimental: IDeg 200 U/mL Drug: insulin degludec

Injected subcutaneously, (under the skin) once daily, in combination with unchanged pre-trial oral anti-diabetic drug (OAD) treatment.

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:

  • Type 2 diabetes (diagnosed clinically) for minimum 24 weeks prior to randomisation (visit 2)
  • Current treatment with basal-only insulin (no prandial insulin) consisting of either insulin detemir once daily (OD), insulin glargine OD or neutral protamine hagedorn (NPH) insulin OD/twice daily (BID) for at least 12 weeks prior to randomisation (visit 2), in combination with stable doses of OAD(s) (metformin, insulin secretagogue (sulfonylurea or glinide), alpha-glucosidase inhibitor, pioglitazone or dipeptidyl peptidase IV (DPP-IV) inhibitor in any approved (according to label) dose or combination. Stable OAD doses are defined as unchanged doses for at least 12 weeks prior to randomisation (visit 2)
  • HbA1c (glycosylated haemoglobin) between 7.0-10.0% (both inclusive) by central laboratory analysis
  • Body mass index (BMI) below or equal to 45 kg/m^2
  • Ability and willingness to adhere to the protocol including self-measured plasma glucose (SMPG) according to the protocol

Exclusion Criteria:

  • Treatment with rosiglitazone within the last 12 weeks prior to randomisation (visit 2)
  • Treatment with glucagon like peptide-1 (GLP-1) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
  • Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)
  • Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period
  • Known or suspected hypersensitivity to trial products or related products
  • The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)
  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: NCT01364428

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Clinical Trial Call Center
Huntsville, Alabama, United States, 35801
United States, Arizona
Novo Nordisk Clinical Trial Call Center
Goodyear, Arizona, United States, 85395
Novo Nordisk Clinical Trial Call Center
Mesa, Arizona, United States, 85213
Novo Nordisk Clinical Trial Call Center
Phoenix, Arizona, United States, 85018
United States, California
Novo Nordisk Clinical Trial Call Center
Chino, California, United States, 91710
Novo Nordisk Clinical Trial Call Center
Concord, California, United States, 94520
Novo Nordisk Clinical Trial Call Center
Greenbrae, California, United States, 94904
Novo Nordisk Clinical Trial Call Center
National City, California, United States, 91950
Novo Nordisk Clinical Trial Call Center
Palm Springs, California, United States, 92262-6972
United States, Florida
Novo Nordisk Clinical Trial Call Center
Bradenton, Florida, United States, 34208
Novo Nordisk Clinical Trial Call Center
Clearwater, Florida, United States, 33765
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
Tampa, Florida, United States, 33603
Novo Nordisk Clinical Trial Call Center
West Palm Beach, Florida, United States, 33401
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Atlanta, Georgia, United States, 30318
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Evansville, Indiana, United States, 47714
United States, Louisiana
Novo Nordisk Clinical Trial Call Center
Metairie, Louisiana, United States, 70002
Novo Nordisk Clinical Trial Call Center
Slidell, Louisiana, United States, 70461-4231
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Rockville, Maryland, United States, 20852
United States, Massachusetts
Novo Nordisk Clinical Trial Call Center
Waltham, Massachusetts, United States, 02453-2717
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Detroit, Michigan, United States, 48235
United States, Missouri
Novo Nordisk Clinical Trial Call Center
Jefferson City, Missouri, United States, 65109-6001
United States, Nebraska
Novo Nordisk Clinical Trial Call Center
Omaha, Nebraska, United States, 68114
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Lawrenceville, New Jersey, United States, 08648
Novo Nordisk Clinical Trial Call Center
Toms River, New Jersey, United States, 08755-8050
United States, New York
Novo Nordisk Clinical Trial Call Center
Staten Island, New York, United States, 10301
Novo Nordisk Clinical Trial Call Center
West Seneca, New York, United States, 14224
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Greensboro, North Carolina, United States, 27408
Novo Nordisk Clinical Trial Call Center
Greenville, North Carolina, United States, 27834
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Franklin, Ohio, United States, 45005
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Melrose Park, Pennsylvania, United States, 19027
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Brentwood, Tennessee, United States, 37027
Novo Nordisk Clinical Trial Call Center
Chattanooga, Tennessee, United States, 37411
Novo Nordisk Clinical Trial Call Center
Chattanooga, Tennessee, United States, 37404
United States, Texas
Novo Nordisk Clinical Trial Call Center
Austin, Texas, United States, 78731
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75246
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75230
Novo Nordisk Clinical Trial Call Center
Hurst, Texas, United States, 76054
Novo Nordisk Clinical Trial Call Center
Irving, Texas, United States, 75061-2210
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78224
United States, Washington
Novo Nordisk Clinical Trial Call Center
Olympia, Washington, United States, 98502
Novo Nordisk Clinical Trial Call Center
Renton, Washington, United States, 98057
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

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01364428     History of Changes
Other Study ID Numbers: NN1250-3923, U1111-1119-2518
Study First Received: May 31, 2011
Last Updated: November 26, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014