Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes (BEGIN™)

December 16, 2016 updated by: Novo Nordisk A/S

A 26-week Trial Investigating the Dosing Flexibility, Efficacy and Safety of NN1250 in Subjects With Type 1 Diabetes With a 26-week Extension (Begin™: Flex T1)

This trial is conducted in Europe and in the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of NN1250 (insulin degludec) in subjects with type 1 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

493

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

  • Belgium
      • Aalst, Belgium, 9300
        • Novo Nordisk Investigational Site
      • Arlon, Belgium, 6700
        • Novo Nordisk Investigational Site
      • Bonheiden, Belgium, 2820
        • Novo Nordisk Investigational Site
      • Brussels, Belgium, 1070
        • Novo Nordisk Investigational Site
      • Leuven, Belgium, 3000
        • Novo Nordisk Investigational Site
  • Germany
      • Bad Kreuznach, Germany, 55545
        • Novo Nordisk Investigational Site
      • Falkensee, Germany, 14612
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 22607
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 21073
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 22391
        • Novo Nordisk Investigational Site
      • Hohenmölsen, Germany, 06679
        • Novo Nordisk Investigational Site
      • Rehburg-Loccum, Germany, 31547
        • Novo Nordisk Investigational Site
      • Rehlingen-Siersburg, Germany, 66780
        • Novo Nordisk Investigational Site
      • St. Ingbert, Germany, 66386
        • Novo Nordisk Investigational Site
      • Völklingen, Germany, 66333
        • Novo Nordisk Investigational Site
  • Greece
      • Athens, Greece, GR-11527
        • Novo Nordisk Investigational Site
      • Athens, Greece, 151 23
        • Novo Nordisk Investigational Site
      • Athens, Greece, GR-10552
        • Novo Nordisk Investigational Site
      • Thessaloniki, Greece, GR-57001
        • Novo Nordisk Investigational Site
      • Thessaloniki, Greece, 54001
        • Novo Nordisk Investigational Site
  • Norway
      • Bergen, Norway, 5021
        • Novo Nordisk Investigational Site
      • Elverum, Norway, 2408
        • Novo Nordisk Investigational Site
      • Hamar, Norway, 2317
        • Novo Nordisk Investigational Site
      • Kongsvinger, Norway, 2212
        • Novo Nordisk Investigational Site
      • Stavanger, Norway, 4011
        • Novo Nordisk Investigational Site
      • Ålesund, Norway, 6003
        • Novo Nordisk Investigational Site
  • Poland
      • Bialystok, Poland, 15-435
        • Novo Nordisk Investigational Site
      • Lublin, Poland, 20-538
        • Novo Nordisk Investigational Site
      • Poznan, Poland, 60-834
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 02-507
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Belfast, United Kingdom, BT16 1RH
        • Novo Nordisk Investigational Site
      • Bristol, United Kingdom, BS10 5NB
        • Novo Nordisk Investigational Site
      • Guildford, United Kingdom, GU2 7XX
        • Novo Nordisk Investigational Site
      • Hull, United Kingdom, HU3 2JZ
        • Novo Nordisk Investigational Site
      • Inverness, United Kingdom, IV2 3JH
        • Novo Nordisk Investigational Site
      • Ipswich, United Kingdom, IP4 5PD
        • Novo Nordisk Investigational Site
      • Newcastle, United Kingdom, NE4 6BE
        • Novo Nordisk Investigational Site
      • Rugby, United Kingdom, CV22 5PX
        • Novo Nordisk Investigational Site
      • Southall, United Kingdom, UB1 3HW
        • Novo Nordisk Investigational Site
      • Stevenage, United Kingdom, SG1 4AB
        • Novo Nordisk Investigational Site
      • Swansea, United Kingdom, SA6 6NL
        • Novo Nordisk Investigational Site
      • Welwyn Garden City, United Kingdom, AL7 4HQ
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Encino, California, United States, 91436
        • Novo Nordisk Investigational Site
      • Fresno, California, United States, 93720
        • Novo Nordisk Investigational Site
      • Huntington Beach, California, United States, 92648
        • Novo Nordisk Investigational Site
      • Long Beach, California, United States, 90806
        • Novo Nordisk Investigational Site
      • Redondo Beach, California, United States, 90277
        • Novo Nordisk Investigational Site
      • Walnut Creek, California, United States, 94598
        • Novo Nordisk Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Novo Nordisk Investigational Site
      • Denver, Colorado, United States, 80209
        • Novo Nordisk Investigational Site
    • Florida
      • DeLand, Florida, United States, 32720
        • Novo Nordisk Investigational Site
      • Hollywood, Florida, United States, 33021
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33136
        • Novo Nordisk Investigational Site
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Novo Nordisk Investigational Site
      • Roswell, Georgia, United States, 30076
        • Novo Nordisk Investigational Site
    • Idaho
      • Nampa, Idaho, United States, 83686-6011
        • Novo Nordisk Investigational Site
    • Illinois
      • Crystal Lake, Illinois, United States, 60012
        • Novo Nordisk Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50314-2610
        • Novo Nordisk Investigational Site
      • Des Moines, Iowa, United States, 50314
        • Novo Nordisk Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Novo Nordisk Investigational Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Novo Nordisk Investigational Site
      • Springfield, Missouri, United States, 65807
        • Novo Nordisk Investigational Site
      • St. Louis, Missouri, United States, 63141
        • Novo Nordisk Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Novo Nordisk Investigational Site
    • New Hampshire
      • Nashua, New Hampshire, United States, 03063
        • Novo Nordisk Investigational Site
    • New Jersey
      • Flemington, New Jersey, United States, 08822-5763
        • Novo Nordisk Investigational Site
    • New York
      • Smithtown, New York, United States, 11787
        • Novo Nordisk Investigational Site
      • Staten Island, New York, United States, 10301
        • Novo Nordisk Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Novo Nordisk Investigational Site
      • Chapel Hill, North Carolina, United States, 27517
        • Novo Nordisk Investigational Site
      • Greenville, North Carolina, United States, 27834
        • Novo Nordisk Investigational Site
      • Morehead City, North Carolina, United States, 28557
        • Novo Nordisk Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • Novo Nordisk Investigational Site
      • Memphis, Tennessee, United States, 38119
        • Novo Nordisk Investigational Site
    • Texas
      • Arlington, Texas, United States, 76014
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75230
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75231
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75246
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77095
        • Novo Nordisk Investigational Site
      • Round Rock, Texas, United States, 78681
        • Novo Nordisk Investigational Site
    • Washington
      • Spokane, Washington, United States, 99208
        • 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 1 diabetes for 12 months or longer, hereof the last 3 months with injection based therapies
  • Current treatment with any basal insulin (e.g. insulin glargine, insulin detemir, NPH insulin) using one or two daily injections and with three or more daily meal-time insulin injections (e.g. insulin aspart, insulin lispro, insulin glulisine, human insulin) used as bolus insulin therapy
  • HbA1c maximum 10.0 % by central laboratory analysis
  • Body Mass Index (BMI) below or equal to 35.0 kg/m^2
  • Ability to self-manage insulin therapy as assessed by confirmation (verbal confirmation at screening visit) of a changed insulin dose in the preceding two months prior to screening
  • Ability and willingness to adhere to the protocol including performance of self measured plasma glucose (SMPG) profiles and self adjustment of insulin doses

Exclusion Criteria:

  • Use within the last 3 months prior to Visit 1 of any antidiabetic glucose lowering drug other than insulin
  • 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 above or equal to 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure above or equal to 100 mmHg)
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
  • Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Flex + insulin aspart
Drug: insulin degludec
Injected subcutaneously (under the skin) once daily
Drug: insulin aspart
At least three daily doses at meal-time
EXPERIMENTAL: Fixed + insulin aspart
Drug: insulin degludec
Injected subcutaneously (under the skin) once daily
Drug: insulin aspart
At least three daily doses at meal-time
ACTIVE_COMPARATOR: IGlar + insulin aspart
Drug: insulin aspart
At least three daily doses at meal-time
Drug: insulin glargine
Insulin glargine injected subcutaneously (under the skin) once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
Time Frame: Week 0, Week 26
Change from baseline in HbA1c after 26 weeks of treatment
Week 0, Week 26
Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
Time Frame: Week 0 to Week 52 + 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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Week 0 to Week 52 + 7 days follow up
Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Time Frame: Week 0 to Week 52 + 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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Week 0 to Week 52 + 7 days follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment
Time Frame: Week 0, Week 26
Change from baseline in FPG after 26 weeks of treatment
Week 0, Week 26
Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
Time Frame: Week 0, Week 52
Change from baseline in HbA1c after 52 weeks of treatment.
Week 0, Week 52
Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment
Time Frame: Week 0, Week 52
Change from baseline in FPG after 52 weeks of treatment.
Week 0, Week 52

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

March 1, 2010

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

March 2, 2010

First Submitted That Met QC Criteria

March 2, 2010

First Posted (ESTIMATE)

March 3, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2017

Last Update Submitted That Met QC Criteria

December 16, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1250-3770
  • U1111-1112-8813 (OTHER: WHO)
  • 2009-012923-27 (EUDRACT_NUMBER)

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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