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DiabetesPhase 3BEGIN™NCT01513473

A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus

A Phase 3 study testing insulin degludec, insulin detemir and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 81 sites in 12 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 Africa, Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus. Read more about this study

Who is it for?
Ages 1 year to 17 years
Conditions the study is for
Diabetes, Diabetes Mellitus, Type 1
What is being tested?
insulin degludec, insulin detemir and insulin aspart
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
81 sitesin 12 countries
Study dates
16 Jan 2012to 30 Jul 2013
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 1 year to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Informed consent, and child assent as age-appropriate, obtained before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject). The parents or legal representative of the child must sign and date the Informed Consent Form according to local requirements. The child, if possible, parents or legal representative of the child must sign and date the Child Assent Form according to local requirements
  • Male or female diagnosed with type 1 diabetes mellitus (T1DM) (based on clinical judgement and supported by laboratory analysis as per local guidelines)
  • Ongoing daily treatment with insulin (any regimen) for at least 3 months prior to Visit 1 (screening). No OADs (oral anti-diabetic drugs) are allowed
  • HbA1c (glycosylated haemoglobin) maximum 11%

Who cannot join

  • Known or suspected hypersensitivity to trial product(s) or related products
  • Previous participation in this trial. Participation is defined as randomisation
  • Girls who are pregnant, breastfeeding or intend to become pregnant
  • Girls who have had menarche and are not using adequate contraceptive measures according to local requirements
  • Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the Investigator (trial physician)
  • More than 1 diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1
  • Significant concomitant disease, except for conditions associated with type 1 diabetes mellitus, which in the Investigator's opinion could interfere with the trial
  • The receipt of any investigational drug within 1 month prior to Visit 1

Trial locations and contacts

81 sites in 12 countries.

81 sites in 12 countries

United States28 sites

  • Novo Nordisk Investigational Site

    Akron, Ohio, 44308

  • Novo Nordisk Investigational Site

    Atlanta, Georgia, 30322

  • Novo Nordisk Investigational Site

    Atlanta, Georgia, 30339

  • Novo Nordisk Investigational Site

    Aurora, Colorado, 80045

  • Novo Nordisk Investigational Site

    Baltimore, Maryland, 21201

  • Novo Nordisk Investigational Site

    Baltimore, Maryland, 21229

  • Novo Nordisk Investigational Site

    Boston, Massachusetts, 02215

  • Novo Nordisk Investigational Site

    Buffalo, New York, 14203

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45229

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75235

  • Novo Nordisk Investigational Site

    Gainesville, Florida, 32608

  • Novo Nordisk Investigational Site

    Hershey, Pennsylvania, 17033

  • Novo Nordisk Investigational Site

    Jacksonville, Florida, 32207

  • Novo Nordisk Investigational Site

    Lexington, Kentucky, 40503

  • Novo Nordisk Investigational Site

    Little Rock, Arkansas, 72202

  • Novo Nordisk Investigational Site

    Louisville, Kentucky, 40202

  • Novo Nordisk Investigational Site

    Maitland, Florida, 32751

  • Novo Nordisk Investigational Site

    Melbourne, Florida, 32901

  • Novo Nordisk Investigational Site

    New Haven, Connecticut, 06511

  • Novo Nordisk Investigational Site

    Norfolk, Virginia, 23507

  • Novo Nordisk Investigational Site

    Orange, California, 92868

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania, 19104

  • Novo Nordisk Investigational Site

    Pittsburgh, Pennsylvania, 15224

  • Novo Nordisk Investigational Site

    Richmond, Virginia, 23235

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78207

  • Novo Nordisk Investigational Site

    San Diego, California, 92123

  • Novo Nordisk Investigational Site

    Tallahassee, Florida, 32308

  • Novo Nordisk Investigational Site

    Worcester, Massachusetts, 01655

Other trials in United States

Japan15 sites

  • Novo Nordisk Investigational Site

    Chuo-shi, Yamanashi, 409 3898

  • Novo Nordisk Investigational Site

    Fukushima, 963-8851

  • Novo Nordisk Investigational Site

    Iruma-gun, Saitama, 350 0495

  • Novo Nordisk Investigational Site

    Kobe-shi, Hyogo, 657-0846

  • Novo Nordisk Investigational Site

    Kochi-shi, Kochi, 780 0952

  • Novo Nordisk Investigational Site

    Kumamoto-shi, Kumamoto, 860 8556

  • Novo Nordisk Investigational Site

    Maebashi-shi, Gunma, 371-8511

  • Novo Nordisk Investigational Site

    Musashino-shi, Tokyo, 180 0023

  • Novo Nordisk Investigational Site

    Niigata-shi, Niigata, 951 8520

  • Novo Nordisk Investigational Site

    Osaka-shi, Osaka, 545 8586

  • Novo Nordisk Investigational Site

    Sendai-shi, Miyagi, 980 8574

  • Novo Nordisk Investigational Site

    Tokyo, 157 8535

  • Novo Nordisk Investigational Site

    Tokyo, 162 8666

  • Novo Nordisk Investigational Site

    Toyonaka-city, Osaka, 560 0004

  • Novo Nordisk Investigational Site

    Tsu-shi, Mie, 514 0125

Other trials in Japan

Russia7 sites

  • Novo Nordisk Investigational Site

    Moscow, 117036

  • Novo Nordisk Investigational Site

    Moscow, 119049

  • Novo Nordisk Investigational Site

    Moscow, 125373

  • Novo Nordisk Investigational Site

    Novosibirsk, 630048

  • Novo Nordisk Investigational Site

    Saint Petersburg, 191144

  • Novo Nordisk Investigational Site

    Saratov, 410028

  • Novo Nordisk Investigational Site

    Saratov, 410054

Other trials in Russia

Finland5 sites

  • Novo Nordisk Investigational Site

    Espoo, 02740

  • Novo Nordisk Investigational Site

    Kuopio, 70210

  • Novo Nordisk Investigational Site

    Mikkeli, 50100

  • Novo Nordisk Investigational Site

    OYS, 90029

  • Novo Nordisk Investigational Site

    Pori, 28500

Other trials in Finland

Netherlands5 sites

  • Novo Nordisk Investigational Site

    Almere Stad, 1315 RA

  • Novo Nordisk Investigational Site

    Amersfoort, 3816 CP

  • Novo Nordisk Investigational Site

    Eindhoven, 5623 EJ

  • Novo Nordisk Investigational Site

    Nijmegen, 6532 CL

  • Novo Nordisk Investigational Site

    Rotterdam, 3011 TA

Other trials in Netherlands

United Kingdom5 sites

  • Novo Nordisk Investigational Site

    Aberdeen, AB25 2ZG

  • Novo Nordisk Investigational Site

    Birmingham, B4 6NH

  • Novo Nordisk Investigational Site

    Manchester, M13 9WL

  • Novo Nordisk Investigational Site

    Norwich, NR4 7UY

  • Novo Nordisk Investigational Site

    Sheffield, S102TH

Other trials in United Kingdom

France4 sites

  • Novo Nordisk Investigational Site

    Bron, 69677

  • Novo Nordisk Investigational Site

    Paris, 75015

  • Novo Nordisk Investigational Site

    Rennes, 35056

  • Novo Nordisk Investigational Site

    Toulouse, 31059

Other trials in France

Germany4 sites

  • Novo Nordisk Investigational Site

    Berlin, 13353

  • Novo Nordisk Investigational Site

    Hanover, 30173

  • Novo Nordisk Investigational Site

    Ludwigshafen, 67059

  • Novo Nordisk Investigational Site

    Münster, 48155

Other trials in Germany

Italy3 sites

  • Novo Nordisk Investigational Site

    Chieti, 66100

  • Novo Nordisk Investigational Site

    Genova, 16147

  • Novo Nordisk Investigational Site

    Roma, 00165

Other trials in Italy

Bulgaria2 sites

  • Novo Nordisk Investigational Site

    Sofia, 1606

  • Novo Nordisk Investigational Site

    Varna, 9010

Other trials in Bulgaria

South Africa2 sites

  • Novo Nordisk Investigational Site

    Cape Town, Western Cape, 7925

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 2193

Other trials in South Africa

North Macedonia1 site

  • Novo Nordisk Investigational Site

    Skopje, 1000

Other trials in North Macedonia

About this study

Official title: A 26-week, Multinational, Multi-centre, Open-Labelled, Randomised, Parallel, Efficacy and Safety Comparison of Insulin Degludec and Insulin Detemir in Children and Adolescents 1 to Less Than 18 Years With Type 1 Diabetes Mellitus on a Basal-bolus Regimen With Insulin Aspart as Bolus Insulin, Followed by a 26-week Extension Investigating Long Term Safety (BEGIN™: Young 1)

This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of this trial is to investigate the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus.

Being tested
insulin degludec, insulin detemir, 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. Dose individually adjusted.

  • insulin detemirDrug

    Injected subcutaneously (under the skin) once or twice daily. Dose individually adjusted.

  • insulin aspartDrug

    Injected subcutaneously (under the skin) as mealtime bolus insulin. Dose individually adjusted.

Study groups in NCT01513473
Study groupRoleWhat they receive
Insulin Degludec + Insulin AspartExperimentalNot described
Receives: Drug: insulin degludec; Drug: insulin aspart
Insulin Detemir +Insulin AspartExperimentalNot described
Receives: Drug: insulin detemir; Drug: insulin aspart

What is being measured

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

  1. Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)

    Change from baseline in HbA1c (%) after 26 weeks of treatment.

    Measured: Week 0, week 26

Secondary outcomes (9)

  1. Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)

    Change from baseline in HbA1c (%) after 52 weeks of treatments.

    Measured: Week 0, week 52

  2. Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)

    Change from baseline in FPG after 26 weeks of treatment.

    Measured: Week 0, week 26

  3. Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)

    Change from baseline in FPG after 52 weeks of treatment.

    Measured: Week 0, week 52

  4. Number of Treatment Emergent Adverse Events (TEAEs)

    TEAE is defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.

    Measured: After 26 weeks and 52 weeks of treatment

  5. Number of Hypoglycaemic Episodes

    Number of hypoglycaemic episodes (severe episodes or episodes with plasma glucose (PG) below or equal to 3.9 mmol/L (70 mg/dL) with or without symptoms of hypoglycaemia) during the trial; nocturnal [11 p.m. - 7 a.m./23:00 - 07:00] and over the entire day (24 hours)

    Measured: After 26 weeks and 52 weeks of treatment

  6. Number of Self-measured Hyperglycaemia (Episodes of PG Above 11.1 mmol/L (200 mg/dL))

    Episodes of PG >11.1mmol/L (200mg/dL)

    Measured: After 26 weeks and 52 weeks of treatment

  7. Number of Episodes With Self Monitored Blood Ketones Above 1.5 mmol (Capillary Blood Ketone Measurement to be Performed if Self-measured Plasma Glucose (SMPG) Exceeds 14.0 mmol/l (250 mg/dL))

    Blood ketones > 1.5mmol/L (Capillary blood ketone measurement to be performed if SMPG exceeds 14.0mmol/L (250mg/dL) )after 26 and 52 weeks of treatment

    Measured: After 26 weeks and 52 weeks of treatment

  8. Steady-state Plasma Concentrations of Insulin Degludec and Insulin Detemir on Three Different Visits (Three Different Weeks) During the First 26 Weeks of Treatment

    Steady state plasma concentrations of insulin degludec and insulin detemir on three different visits (three different weeks) during the trial.

    Measured: Between week 1 and week 26

  9. Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)

    Antibody measurements : the values presented are week 52 (LOCF). The measurement of insulin antibodies after 26 and 52 weeks of treatment was done to fulfil the requirement of monitoring the long term immunogenicity. The unit of measure is percentage bound/total (%B/T) for these antibodies. The Antibodies cross reacting to Human Insulin is abbreviated as X-reacting AB Hu Insulin below)

    Measured: After 52 weeks of treatment

Timeline

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

  1. First posted20 Jan 2012 (estimated)
  2. Study start16 Jan 2012
  3. Primary completion30 Jul 2013
  4. Study completion30 Jul 2013

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
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01513473
Sponsor's protocol ID
NN1250-3561
Other IDs
2011-003148-39, P/44/2010, U1111-1122-4758
Acronym
BEGIN™
Status last verified
Jun 2019
First submitted
16 Jan 2012
Last updated
13 Jun 2019
Data monitoring committee
No

Publications

  • Thalange N, Deeb L, Klingensmith G, Franco DR, Bardtrum L, Tutkunkardas D, Danne T. The rate of hyperglycemia and ketosis with insulin degludec-based treatment compared with insulin detemir in pediatric patients with type 1 diabetes: An analysis of data from two randomized trials. Pediatr Diabetes. 2019 May;20(3):314-320. doi: 10.1111/pedi.12821. Epub 2019 Feb 10.

    PubMed 30666772

  • Thalange N, Deeb L, Iotova V, Kawamura T, Klingensmith G, Philotheou A, Silverstein J, Tumini S, Ocampo Francisco AM, Kinduryte O, Danne T. Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2015 May;16(3):164-76. doi: 10.1111/pedi.12263. Epub 2015 Feb 12.

    PubMed 25683037

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin degludec, insulin detemir and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 81 sites in 12 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 4 inclusion and 8 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 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Japan, Russia, Finland, Netherlands and 7 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 12 Jan 2016). 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?

Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory) (time frame: Week 0, week 26). 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 NCT01513473, which also lists 2 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 13 Jun 2019.

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