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DiabetesPhase 3BEGIN™NCT01074268

Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes

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 69 sites in 8 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 Asia, Europe, Japan and South America. The aim of the trial is to compare the efficacy, safety and tolerability of NN1250 (insulin degludec ([Deg]) with insulin detemir (IDet), both combined with insulin aspart. 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 detemir and insulin aspart
Could I receive a placebo?
No, everyone receives an active treatment
How many people
456 participants
Where
69 sitesin 8 countries
Study dates
Feb 2010to Dec 2010
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 mellitus for at least 12 months
  • Current treatment with any basal bolus insulin for at least 12 months
  • HbA1c below or equal to 10.0%
  • Body Mass Index (BMI) below or equal to 35.0 kg/m^2
  • For Japan only: Minimum age is 20 years
  • For the extension trial only: Completed the six-month treatment period in trial NN1250-3585 (NCT01074268)

Who cannot join

  • Use of any other antidiabetic drug than insulin within the last 3 months
  • Cardiovascular disease within the last 6 months
  • Uncontrolled treated/untreated severe hypertension
  • Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
  • Cancer and medical history of cancer

Trial locations and contacts

69 sites in 8 countries.

69 sites in 8 countries

Japan15 sites

  • Novo Nordisk Investigational Site

    Chuo-ku, Tokyo, 103 0002

  • Novo Nordisk Investigational Site

    Ebina-shi, 243 0432

  • Novo Nordisk Investigational Site

    Imizu-shi, 939 0363

  • Novo Nordisk Investigational Site

    Izumisano, 598 0048

  • Novo Nordisk Investigational Site

    Koriyama-shi, Fukushima, 963 8851

  • Novo Nordisk Investigational Site

    Kumamoto-shi,Kumamoto, 862 0976

  • Novo Nordisk Investigational Site

    Miyazaki, 880 0034

  • Novo Nordisk Investigational Site

    Naka-shi, Ibaraki, 311 0113

  • Novo Nordisk Investigational Site

    Nishinomiya-shi, Hygo, 662 0971

  • Novo Nordisk Investigational Site

    Ōita, 870 0039

  • Novo Nordisk Investigational Site

    Ota-ku, Tokyo, 144 0035

  • Novo Nordisk Investigational Site

    Sapporo-shi, Hokkaido, 060 0062

  • Novo Nordisk Investigational Site

    Sapporo-shi, Hokkaido, 060-0001

  • Novo Nordisk Investigational Site

    Sapporo-shi, Hokkaido, 062 0007

  • Novo Nordisk Investigational Site

    Yokohama, 235 0045

Other trials in Japan

United Kingdom14 sites

  • Novo Nordisk Investigational Site

    Bath, BA1 3NG

  • Novo Nordisk Investigational Site

    Blackburn, BB2 3HH

  • Novo Nordisk Investigational Site

    Carmarthen, SA31 2AF

  • Novo Nordisk Investigational Site

    Edinburgh, EH4 2XU

  • Novo Nordisk Investigational Site

    Leicester, LE1 5WW

  • Novo Nordisk Investigational Site

    Manchester, M8 5RB

  • Novo Nordisk Investigational Site

    Middlesbrough, TS4 3BW

  • Novo Nordisk Investigational Site

    Northampton, NN1 5BD

  • Novo Nordisk Investigational Site

    Nottingham, NG7 2UH

  • Novo Nordisk Investigational Site

    Penarth, CF64 2XX

  • Novo Nordisk Investigational Site

    Plymouth, PL6 8BQ

  • Novo Nordisk Investigational Site

    Sheffield, S5 7AU

  • Novo Nordisk Investigational Site

    Torquay, TQ2 7AA

  • Novo Nordisk Investigational Site

    Wirral, Merseyside, CH63 4JY

Other trials in United Kingdom

Italy12 sites

  • Novo Nordisk Investigational Site

    Bari, 70124

  • Novo Nordisk Investigational Site

    Forlì, 47100

  • Novo Nordisk Investigational Site

    Gazi, 98124

  • Novo Nordisk Investigational Site

    Milan, 200122

  • Novo Nordisk Investigational Site

    Milan, 20162

  • Novo Nordisk Investigational Site

    Olbia, 07026

  • Novo Nordisk Investigational Site

    Palermo, 90127

  • Novo Nordisk Investigational Site

    Partinico, 90047

  • Novo Nordisk Investigational Site

    Roma, 00168

  • Novo Nordisk Investigational Site

    Torino, 10126

  • Novo Nordisk Investigational Site

    Treviglio, 24047

  • Novo Nordisk Investigational Site

    Treviso, 31100

Other trials in Italy

India10 sites

  • Novo Nordisk Investigational Site

    Ahmedabad, 380015

  • Novo Nordisk Investigational Site

    Bangalore, Karnataka, 560034

  • Novo Nordisk Investigational Site

    Bilāspur, 495001

  • Novo Nordisk Investigational Site

    Chennai, Tamil Nadu, 600029

  • Novo Nordisk Investigational Site

    Chennai, Tamil Nadu, 600086

  • Novo Nordisk Investigational Site

    Dhantoli, Nagpur, 440012

  • Novo Nordisk Investigational Site

    Hyderabad, 500034

  • Novo Nordisk Investigational Site

    New Dehli, 110029

  • Novo Nordisk Investigational Site

    Ramdaspeth / Nagpur, 440010

  • Novo Nordisk Investigational Site

    Thriruvananthapuram, 695 032

Other trials in India

Finland8 sites

  • Novo Nordisk Investigational Site

    Hämeenlinna, 13530

  • Novo Nordisk Investigational Site

    Helsinki, 00250

  • Novo Nordisk Investigational Site

    Helsinki, 00260

  • Novo Nordisk Investigational Site

    Kuopio, 70210

  • Novo Nordisk Investigational Site

    Lahti, 15110

  • Novo Nordisk Investigational Site

    Seinäjoki, 60220

  • Novo Nordisk Investigational Site

    Tampere, 33520

  • Novo Nordisk Investigational Site

    Turku, FI-20520

Other trials in Finland

Brazil5 sites

  • Novo Nordisk Investigational Site

    Marília, 17519-000

  • Novo Nordisk Investigational Site

    Porto Alegre, Rio Grande do Sul, 91350-250

  • Novo Nordisk Investigational Site

    Porto Alegre, 90035-170

  • Novo Nordisk Investigational Site

    São Paulo, São Paulo, 01244-030

  • Novo Nordisk Investigational Site

    São Paulo, 04022-001

Other trials in Brazil

Argentina4 sites

  • Novo Nordisk Investigational Site

    Caba, C1440AAD

  • Novo Nordisk Investigational Site

    Ciudad Autónoma de Bs As, C1426ABP

  • Novo Nordisk Investigational Site

    Mar del Plata, B7600FZN

  • Novo Nordisk Investigational Site

    Rosario, 2000

Other trials in Argentina

North Macedonia1 site

  • Novo Nordisk Investigational Site

    Skopje, 1000

Other trials in North Macedonia

About this study

Official title: NN1250-3585: A Trial Investigating the Efficacy and Safety of NN1250 Compared to Insulin Detemir in Subjects With Type 1 Diabetes Mellitus in a Basal/Bolus Treatment Regimen / NN1250-3725: An Extension Trial to NN1250-3585 Investigating Safety and Efficacy of NN1250 Compared to Insulin Detemir in Subjects With Type 1 Diabetes Mellitus in a Basal/Bolus Treatment Regimen (BEGIN™: BB T1)

This trial is conducted in Asia, Europe, Japan and South America. The aim of the trial is to compare the efficacy, safety and tolerability of NN1250 (insulin degludec ([Deg]) with insulin detemir (IDet), both combined with insulin aspart.

The main period is registered internally at Novo Nordisk as NN1250-3585 while the extension period is registered as NN1250-3725.

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 s.c. (under the skin) once daily. Dose was individually adjusted.

  • insulin detemirDrug

    Injected s.c. (under the skin) once daily or twice daily (BID). Dose was individually adjusted.

  • insulin aspartDrug

    Injected s.c. (under the skin) as mealtime insulin. Dose was individually adjusted.

Study groups in NCT01074268
Study groupRoleWhat they receive
IDeg ODExperimentalNot described
Receives: Drug: insulin degludec; Drug: insulin aspart
IDetActive comparatorNot 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. 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 Treatment Emergent Adverse Events (AEs)

    Rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no/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 or important medical issues

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

Secondary outcomes (9)

  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): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26

    Mean of 9-point self-measured plasma glucose profile (SMPG) after week 26. Plasma glucose was measured before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal, 90 minutes after the start of main evening meal, before bedtime, at 04:00 AM and before breakfast on the following day.

    Measured: Week 26

  3. Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52

    Mean of 9-point self-measured plasma glucose profile (SMPG) at week 52. Plasma glucose was measured before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal, 90 minutes after the start of main evening meal, before bedtime, at 04:00 AM and before breakfast on the following day.

    Measured: Week 52

  4. 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

  5. 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

  6. Main Trial (Secondary 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: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where the subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms.

    Measured: Week 0 to Week 26 + 7 days follow up

  7. Main Trial (Secondary 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: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.

    Measured: Week 0 to Week 26 + 7 days follow up

  8. Extension Trial (Secondary 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: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where the subject was able to treat her/himself and plasma glucose below 3.1 mmol/L with or without symptoms

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

  9. Extension Trial (Secondary 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: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.

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

Timeline

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

  1. First posted24 Feb 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionDec 2010
  4. Study completionDec 2010

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
456 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01074268
Sponsor's protocol ID
NN1250-3585
Other IDs
2009-011672-29, U1111-1111-7249, JapicCTI-101067, 2009-015721-36, U1111-1114-9479, JapicCTI-22-0677, 2009
Acronym
BEGIN™
Status last verified
Jan 2017
First submitted
22 Feb 2010
Last updated
6 Mar 2017
Data monitoring committee
No

Publications

  • Davies MJ, Gross JL, Ono Y, Sasaki T, Bantwal G, Gall MA, Niemeyer M, Seino H; BEGIN BB T1 Study Group. Efficacy and safety of insulin degludec given as part of basal-bolus treatment with mealtime insulin aspart in type 1 diabetes: a 26-week randomized, open-label, treat-to-target non-inferiority trial. Diabetes Obes Metab. 2014 Oct;16(10):922-30. doi: 10.1111/dom.12298. Epub 2014 May 8.

    PubMed 24702700

  • Davies M, Sasaki T, Gross JL, Bantwal G, Ono Y, Nishida T, Tojjar D, Seino H. Comparison of insulin degludec with insulin detemir in type 1 diabetes: a 1-year treat-to-target trial. Diabetes Obes Metab. 2016 Jan;18(1):96-9. doi: 10.1111/dom.12573. Epub 2015 Oct 19.

    PubMed 26435472

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 69 sites in 8 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 6 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 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in Japan, United Kingdom, Italy, India, Finland and 3 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 16 Nov 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 2 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 NCT01074268, 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 6 Mar 2017.

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