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DiabetesPhase 3BEGIN™NCT01079234

Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes

A Phase 3 study testing insulin degludec, insulin glargine and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 82 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes, Diabetes Mellitus, Type 1
What is being tested?
insulin degludec, insulin glargine and insulin aspart
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
493 participants
Where
82 sitesin 7 countries
Study dates
Mar 2010to May 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

82 sites in 7 countries.

82 sites in 7 countries

United States40 sites

  • Novo Nordisk Investigational Site

    Arlington, Texas, 76014

  • Novo Nordisk Investigational Site

    Asheville, North Carolina, 28803

  • Novo Nordisk Investigational Site

    Aurora, Colorado, 80045

  • Novo Nordisk Investigational Site

    Baltimore, Maryland, 21204

  • Novo Nordisk Investigational Site

    Chapel Hill, North Carolina, 27517

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee, 37411

  • Novo Nordisk Investigational Site

    Crystal Lake, Illinois, 60012

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75230

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75231

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75246

  • Novo Nordisk Investigational Site

    DeLand, Florida, 32720

  • Novo Nordisk Investigational Site

    Denver, Colorado, 80209

  • Novo Nordisk Investigational Site

    Des Moines, Iowa, 50314-2610

  • Novo Nordisk Investigational Site

    Des Moines, Iowa, 50314

  • Novo Nordisk Investigational Site

    Encino, California, 91436

  • Novo Nordisk Investigational Site

    Flemington, New Jersey, 08822-5763

  • Novo Nordisk Investigational Site

    Fresno, California, 93720

  • Novo Nordisk Investigational Site

    Greenville, North Carolina, 27834

  • Novo Nordisk Investigational Site

    Greer, South Carolina, 29651

  • Novo Nordisk Investigational Site

    Hollywood, Florida, 33021

  • Novo Nordisk Investigational Site

    Houston, Texas, 77095

  • Novo Nordisk Investigational Site

    Huntington Beach, California, 92648

  • Novo Nordisk Investigational Site

    Jefferson City, Missouri, 65109

  • Novo Nordisk Investigational Site

    Lawrenceville, Georgia, 30046

  • Novo Nordisk Investigational Site

    Long Beach, California, 90806

  • Novo Nordisk Investigational Site

    Memphis, Tennessee, 38119

  • Novo Nordisk Investigational Site

    Miami, Florida, 33136

  • Novo Nordisk Investigational Site

    Morehead City, North Carolina, 28557

  • Novo Nordisk Investigational Site

    Nampa, Idaho, 83686-6011

  • Novo Nordisk Investigational Site

    Nashua, New Hampshire, 03063

  • Novo Nordisk Investigational Site

    Omaha, Nebraska, 68114

  • Novo Nordisk Investigational Site

    Redondo Beach, California, 90277

  • Novo Nordisk Investigational Site

    Roswell, Georgia, 30076

  • Novo Nordisk Investigational Site

    Round Rock, Texas, 78681

  • Novo Nordisk Investigational Site

    Smithtown, New York, 11787

  • Novo Nordisk Investigational Site

    Spokane, Washington, 99208

  • Novo Nordisk Investigational Site

    Springfield, Missouri, 65807

  • Novo Nordisk Investigational Site

    St Louis, Missouri, 63141

  • Novo Nordisk Investigational Site

    Staten Island, New York, 10301

  • Novo Nordisk Investigational Site

    Walnut Creek, California, 94598

Other trials in United States

United Kingdom12 sites

  • Novo Nordisk Investigational Site

    Belfast, BT16 1RH

  • Novo Nordisk Investigational Site

    Bristol, BS10 5NB

  • Novo Nordisk Investigational Site

    Guildford, GU2 7XX

  • Novo Nordisk Investigational Site

    Hull, HU3 2JZ

  • Novo Nordisk Investigational Site

    Inverness, IV2 3JH

  • Novo Nordisk Investigational Site

    Ipswich, IP4 5PD

  • Novo Nordisk Investigational Site

    Newcastle, NE4 6BE

  • Novo Nordisk Investigational Site

    Rugby, CV22 5PX

  • Novo Nordisk Investigational Site

    Southall, UB1 3HW

  • Novo Nordisk Investigational Site

    Stevenage, SG1 4AB

  • Novo Nordisk Investigational Site

    Swansea, SA6 6NL

  • Novo Nordisk Investigational Site

    Welwyn Garden City, AL7 4HQ

Other trials in United Kingdom

Germany10 sites

  • Novo Nordisk Investigational Site

    Bad Kreuznach, 55545

  • Novo Nordisk Investigational Site

    Falkensee, 14612

  • Novo Nordisk Investigational Site

    Hamburg, 21073

  • Novo Nordisk Investigational Site

    Hamburg, 22391

  • Novo Nordisk Investigational Site

    Hamburg, 22607

  • Novo Nordisk Investigational Site

    Hohenmölsen, 06679

  • Novo Nordisk Investigational Site

    Rehburg-Loccum, 31547

  • Novo Nordisk Investigational Site

    Rehlingen-Siersburg, 66780

  • Novo Nordisk Investigational Site

    Saint Ingbert, 66386

  • Novo Nordisk Investigational Site

    Völklingen, 66333

Other trials in Germany

Norway6 sites

  • Novo Nordisk Investigational Site

    Ålesund, 6003

  • Novo Nordisk Investigational Site

    Bergen, 5021

  • Novo Nordisk Investigational Site

    Elverum, 2408

  • Novo Nordisk Investigational Site

    Hamar, 2317

  • Novo Nordisk Investigational Site

    Kongsvinger, 2212

  • Novo Nordisk Investigational Site

    Stavanger, 4011

Other trials in Norway

Belgium5 sites

  • Novo Nordisk Investigational Site

    Aalst, 9300

  • Novo Nordisk Investigational Site

    Arlon, 6700

  • Novo Nordisk Investigational Site

    Bonheiden, 2820

  • Novo Nordisk Investigational Site

    Brussels, 1070

  • Novo Nordisk Investigational Site

    Leuven, 3000

Other trials in Belgium

Greece5 sites

  • Novo Nordisk Investigational Site

    Athens, 151 23

  • Novo Nordisk Investigational Site

    Athens, GR-10552

  • Novo Nordisk Investigational Site

    Athens, GR-11527

  • Novo Nordisk Investigational Site

    Thessaloniki, 54001

  • Novo Nordisk Investigational Site

    Thessaloniki, GR-57001

Other trials in Greece

Poland4 sites

  • Novo Nordisk Investigational Site

    Bialystok, 15-435

  • Novo Nordisk Investigational Site

    Lublin, 20-538

  • Novo Nordisk Investigational Site

    Poznan, 60-834

  • Novo Nordisk Investigational Site

    Warsaw, 02-507

Other trials in Poland

About this study

Official title: 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.

Being tested
insulin degludec, insulin glargine, insulin aspart
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • insulin degludecDrug

    Injected subcutaneously (under the skin) once daily

  • insulin glargineDrug

    Insulin glargine injected subcutaneously (under the skin) once daily

  • insulin aspartDrug

    At least three daily doses at meal-time

Study groups in NCT01079234
Study groupRoleWhat they receive
Flex + insulin aspartExperimentalNot described
Receives: Drug: insulin degludec; Drug: insulin aspart
Fixed + insulin aspartExperimentalNot described
Receives: Drug: insulin degludec; Drug: insulin aspart
IGlar + insulin aspartActive comparatorNot described
Receives: Drug: insulin glargine; Drug: insulin aspart

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment

    Change from baseline in HbA1c after 26 weeks of treatment

    Measured: Week 0, Week 26

  2. Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

    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.

    Measured: Week 0 to Week 52 + 7 days follow up

  3. Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

    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.

    Measured: Week 0 to Week 52 + 7 days follow up

Secondary outcomes (3)

  1. Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment

    Change from baseline in HbA1c after 52 weeks of treatment.

    Measured: Week 0, Week 52

  2. Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment

    Change from baseline in FPG after 26 weeks of treatment

    Measured: Week 0, Week 26

  3. Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment

    Change from baseline in FPG after 52 weeks of treatment.

    Measured: Week 0, Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionNov 2010
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
493 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01079234
Sponsor's protocol ID
NN1250-3770
Other IDs
U1111-1112-8813, 2009-012923-27, 2009
Acronym
BEGIN™
Status last verified
Dec 2016
First submitted
2 Mar 2010
Last updated
9 Feb 2017
Data monitoring committee
No

Publications

  • Ratner RE, Gough SC, Mathieu C, Del Prato S, Bode B, Mersebach H, Endahl L, Zinman B. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013 Feb;15(2):175-84. doi: 10.1111/dom.12032. Epub 2012 Dec 3.

    PubMed 23130654

  • Heller S, Mathieu C, Kapur R, Wolden ML, Zinman B. A meta-analysis of rate ratios for nocturnal confirmed hypoglycaemia with insulin degludec vs. insulin glargine using different definitions for hypoglycaemia. Diabet Med. 2016 Apr;33(4):478-87. doi: 10.1111/dme.13002. Epub 2015 Dec 13.

    PubMed 26484727

  • Sorli C, Warren M, Oyer D, Mersebach H, Johansen T, Gough SC. Elderly patients with diabetes experience a lower rate of nocturnal hypoglycaemia with insulin degludec than with insulin glargine: a meta-analysis of phase IIIa trials. Drugs Aging. 2013 Dec;30(12):1009-18. doi: 10.1007/s40266-013-0128-2.

    PubMed 24170235

  • Einhorn D, Handelsman Y, Bode BW, Endahl LA, Mersebach H, King AB. PATIENTS ACHIEVING GOOD GLYCEMIC CONTROL (HBA1c <7%) EXPERIENCE A LOWER RATE OF HYPOGLYCEMIA WITH INSULIN DEGLUDEC THAN WITH INSULIN GLARGINE: A META-ANALYSIS OF PHASE 3A TRIALS. Endocr Pract. 2015 Aug;21(8):917-26. doi: 10.4158/EP14523.OR. Epub 2015 Jun 29.

    PubMed 26121451

  • Russell-Jones D, Gall MA, Niemeyer M, Diamant M, Del Prato S. Insulin degludec results in lower rates of nocturnal hypoglycaemia and fasting plasma glucose vs. insulin glargine: A meta-analysis of seven clinical trials. Nutr Metab Cardiovasc Dis. 2015 Oct;25(10):898-905. doi: 10.1016/j.numecd.2015.06.005. Epub 2015 Jun 18.

    PubMed 26232910

  • Vora J, Seufert J, Solberg H, Kinduryte O, Johansen T, Hollander P. Insulin degludec does not increase antibody formation versus insulin glargine: an evaluation of phase IIIa trials. Diabetes Obes Metab. 2016 Jul;18(7):716-20. doi: 10.1111/dom.12621. Epub 2016 Feb 8.

    PubMed 26663320

  • Mathieu C, Hollander P, Miranda-Palma B, Cooper J, Franek E, Russell-Jones D, Larsen J, Tamer SC, Bain SC; NN1250-3770 (BEGIN: Flex T1) Trial Investigators. Efficacy and safety of insulin degludec in a flexible dosing regimen vs insulin glargine in patients with type 1 diabetes (BEGIN: Flex T1): a 26-week randomized, treat-to-target trial with a 26-week extension. J Clin Endocrinol Metab. 2013 Mar;98(3):1154-62. doi: 10.1210/jc.2012-3249. Epub 2013 Feb 7.

    PubMed 23393185

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin degludec, insulin glargine and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 82 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, United Kingdom, Germany, Norway, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment (time frame: Week 0, Week 26). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01079234, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.

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