Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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: January 20, 2017
Last verified: January 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
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 ]
    Change from baseline in HbA1c after 22 weeks of treatment


Secondary Outcome Measures:
  • Change in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, Week 22 ]
    Change from baseline in FPG after 22 weeks of treatment.

  • Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 22 + 7 days follow up ]
    Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.

  • Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 22 + 7 days follow up ]
    Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.

  • Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 22 + 7 days follow up ]
    Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.


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 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.

Experimental: IDeg 100 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   (Adult, Senior)
Sexes Eligible for Study:   All
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 Investigational Site
Huntsville, Alabama, United States, 35801
United States, Arizona
Novo Nordisk Investigational Site
Goodyear, Arizona, United States, 85395
Novo Nordisk Investigational Site
Mesa, Arizona, United States, 85213
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85018
United States, California
Novo Nordisk Investigational Site
Concord, California, United States, 94520
Novo Nordisk Investigational Site
Greenbrae, California, United States, 94904
Novo Nordisk Investigational Site
Montclair, California, United States, 91763
Novo Nordisk Investigational Site
National City, California, United States, 91950
Novo Nordisk Investigational Site
Palm Springs, California, United States, 92262
United States, Florida
Novo Nordisk Investigational Site
Bradenton, Florida, United States, 34201
Novo Nordisk Investigational Site
Clearwater, Florida, United States, 33765
Novo Nordisk Investigational Site
Kissimmee, Florida, United States, 34741
Novo Nordisk Investigational Site
Miami, Florida, United States, 33135
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33603
Novo Nordisk Investigational Site
West Palm Beach, Florida, United States, 33401
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30318
United States, Illinois
Novo Nordisk Investigational Site
Springfield, Illinois, United States, 62711
United States, Indiana
Novo Nordisk Investigational Site
Evansville, Indiana, United States, 47714
United States, Louisiana
Novo Nordisk Investigational Site
Metairie, Louisiana, United States, 70002
Novo Nordisk Investigational Site
Slidell, Louisiana, United States, 70461-4231
United States, Maryland
Novo Nordisk Investigational Site
Rockville, Maryland, United States, 20852
United States, Massachusetts
Novo Nordisk Investigational Site
Waltham, Massachusetts, United States, 02453-2717
United States, Michigan
Novo Nordisk Investigational Site
Detroit, Michigan, United States, 48235
United States, Missouri
Novo Nordisk Investigational Site
Jefferson City, Missouri, United States, 65109
United States, Nebraska
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68114
United States, New Jersey
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, United States, 08648
Novo Nordisk Investigational Site
Toms River, New Jersey, United States, 08755-8050
United States, New York
Novo Nordisk Investigational Site
Staten Island, New York, United States, 10301
Novo Nordisk Investigational Site
West Seneca, New York, United States, 14224
United States, North Carolina
Novo Nordisk Investigational Site
Greensboro, North Carolina, United States, 27408
Novo Nordisk Investigational Site
Greenville, North Carolina, United States, 27834
United States, Ohio
Novo Nordisk Investigational Site
Canton, Ohio, United States, 44718
Novo Nordisk Investigational Site
Franklin, Ohio, United States, 45005
United States, Pennsylvania
Novo Nordisk Investigational Site
Melrose Park, Pennsylvania, United States, 19027
United States, Tennessee
Novo Nordisk Investigational Site
Brentwood, Tennessee, United States, 37027
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37404
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37411
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75230
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75246
Novo Nordisk Investigational Site
Hurst, Texas, United States, 76054
Novo Nordisk Investigational Site
Irving, Texas, United States, 75061-2210
Novo Nordisk Investigational Site
Round Rock, Texas, United States, 78681
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78224
United States, Washington
Novo Nordisk Investigational Site
Olympia, Washington, United States, 98502
Novo Nordisk Investigational Site
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:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01364428     History of Changes
Other Study ID Numbers: NN1250-3923
U1111-1119-2518 ( Registry Identifier: WHO )
Study First Received: May 31, 2011
Results First Received: October 16, 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, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 28, 2017