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

January 20, 2017 updated by: Novo Nordisk A/S

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

373

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Novo Nordisk Investigational Site
    • Arizona
      • Goodyear, Arizona, United States, 85395
        • Novo Nordisk Investigational Site
      • Mesa, Arizona, United States, 85213
        • Novo Nordisk Investigational Site
      • Phoenix, Arizona, United States, 85018
        • Novo Nordisk Investigational Site
    • California
      • 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
        • Novo Nordisk Investigational Site
    • Florida
      • 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
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Novo Nordisk Investigational Site
    • Illinois
      • Springfield, Illinois, United States, 62711
        • Novo Nordisk Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Novo Nordisk Investigational Site
    • Louisiana
      • Metairie, Louisiana, United States, 70002
        • Novo Nordisk Investigational Site
      • Slidell, Louisiana, United States, 70461-4231
        • Novo Nordisk Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Waltham, Massachusetts, United States, 02453-2717
        • Novo Nordisk Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48235
        • Novo Nordisk Investigational Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Novo Nordisk Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Novo Nordisk Investigational Site
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Novo Nordisk Investigational Site
      • Toms River, New Jersey, United States, 08755-8050
        • Novo Nordisk Investigational Site
    • New York
      • Staten Island, New York, United States, 10301
        • Novo Nordisk Investigational Site
      • West Seneca, New York, United States, 14224
        • Novo Nordisk Investigational Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Novo Nordisk Investigational Site
      • Greenville, North Carolina, United States, 27834
        • Novo Nordisk Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Novo Nordisk Investigational Site
      • Franklin, Ohio, United States, 45005
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Melrose Park, Pennsylvania, United States, 19027
        • Novo Nordisk Investigational Site
    • Tennessee
      • Brentwood, Tennessee, United States, 37027
        • Novo Nordisk Investigational Site
      • Chattanooga, Tennessee, United States, 37404
        • Novo Nordisk Investigational Site
      • Chattanooga, Tennessee, United States, 37411
        • Novo Nordisk Investigational Site
    • Texas
      • 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
        • Novo Nordisk Investigational Site
    • Washington
      • Olympia, Washington, United States, 98502
        • Novo Nordisk Investigational Site
      • Renton, Washington, United States, 98057
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycosylated Haemoglobin (HbA1c)
Time Frame: Week 0, Week 22
Change from baseline in HbA1c after 22 weeks of treatment
Week 0, Week 22

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fasting Plasma Glucose (FPG)
Time Frame: Week 0, Week 22
Change from baseline in FPG after 22 weeks of treatment.
Week 0, Week 22
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.
Week 0 to Week 22 + 7 days follow up
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.
Week 0 to Week 22 + 7 days follow up
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.
Week 0 to Week 22 + 7 days follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

May 31, 2011

First Submitted That Met QC Criteria

May 31, 2011

First Posted (Estimate)

June 2, 2011

Study Record Updates

Last Update Posted (Actual)

March 6, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1250-3923
  • U1111-1119-2518 (Registry Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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