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DiabetesPhase 3BEGIN™NCT01849289

A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes

A Phase 3 study testing Insulin Degludec and Insulin Glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 81 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 was conducted in Africa, Asia, Europe, North and South America. The aim of the trial was to compare efficacy and safety of insulin degludec and insulin glargine in insulin naïve subjects with type 2 diabetes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes, Diabetes Mellitus, Type 2
What is being tested?
Insulin Degludec and Insulin Glargine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
833 participants
Where
81 sitesin 7 countries
Study dates
2 Jun 2013to 15 May 2014
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 2 diabetes mellitus (diagnosed clinically) for at least 6 months
  • Insulin naïve subjects (Allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
  • Current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, alfa-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months prior to randomisation (Visit 2) with the minimum doses stated: metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling, DPP-IV inhibitor: minimum 100 mg daily or according to local labelling, alfa-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
  • HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive) by central laboratory analysis
  • BMI (Body Mass Index) below or equal to 40.0 kg/m^2

Who cannot join

  • Treatment with TZDs (thiazoledinedione), or GLP-1 (glucagon-like peptide 1) receptor agonists within the last 3 months prior to Visit 1 (screening)
  • Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO (monoamine oxidase) inhibitors
  • Cardiovascular disease within the last 6 months prior to Visit 1 (screening) defined as stroke; decompensated heart failure NYHA (New York Heart Association) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
  • Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes mellitus, which in the Investigator's opinion could interfere with the results of the trial
  • Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period
  • Known or suspected hypersensitivity to trial product(s) or related products

Trial locations and contacts

81 sites in 7 countries.

81 sites in 7 countries

China33 sites

  • Novo Nordisk Investigational Site

    Beijing, Beijing Municipality, 100029

  • Novo Nordisk Investigational Site

    Beijing, Beijing Municipality, 100039

  • Novo Nordisk Investigational Site

    Beijing, Beijing Municipality, 100191

  • Novo Nordisk Investigational Site

    Beijing, Beijing Municipality, 100700

  • Novo Nordisk Investigational Site

    Beijing, Beijing Municipality, 100730

  • Novo Nordisk Investigational Site

    Beijing, Beijing Municipality, 100853

  • Novo Nordisk Investigational Site

    Changchun, Jilin, 130041

  • Novo Nordisk Investigational Site

    Chongqing, Chongqing Municipality, 400010

  • Novo Nordisk Investigational Site

    Chongqing, Chongqing Municipality, 400016

  • Novo Nordisk Investigational Site

    Chongqing, Chongqing Municipality, 404000

  • Novo Nordisk Investigational Site

    Fuzhou, Fujian, 350025

  • Novo Nordisk Investigational Site

    Guangzhou, Guangdong, 510120

  • Novo Nordisk Investigational Site

    Guiyang, Guizhou, 550004

  • Novo Nordisk Investigational Site

    Hangzhou, Zhejiang, 310003

  • Novo Nordisk Investigational Site

    Harbin, Heilongjiang, 150086

  • Novo Nordisk Investigational Site

    Hefei, Anhui, 230001

  • Novo Nordisk Investigational Site

    Kunming, Yunnan, 650101

  • Novo Nordisk Investigational Site

    Nanchang, Jiangxi, 330006

  • Novo Nordisk Investigational Site

    Nanning, Guangxi, 530007

  • Novo Nordisk Investigational Site

    Shanghai, Shanghai Municipality, 200040

  • Novo Nordisk Investigational Site

    Shanghai, Shanghai Municipality, 200072

  • Novo Nordisk Investigational Site

    Shenyang, Liaoning, 110004

  • Novo Nordisk Investigational Site

    Shenyang, Liaoning, 110021

  • Novo Nordisk Investigational Site

    Shijiazhuang, Hebei, 050051

  • Novo Nordisk Investigational Site

    Shijiazhuang, Hebei, 050082

  • Novo Nordisk Investigational Site

    Siping, Jilin, 136000

  • Novo Nordisk Investigational Site

    Wenzhou, Zhejiang, 325000

  • Novo Nordisk Investigational Site

    Wuhan, Hubei, 430030

  • Novo Nordisk Investigational Site

    Wuhan, Hubei, 430034

  • Novo Nordisk Investigational Site

    Xi'an, Shaanxi, 710032

  • Novo Nordisk Investigational Site

    Yangzhou, Jiangsu, 225001

  • Novo Nordisk Investigational Site

    Yueyang, Hunan, 414000

  • Novo Nordisk Investigational Site

    Zhenjiang, Jiangsu, 212001

Other trials in China

United States18 sites

  • Novo Nordisk Investigational Site

    Anaheim, California, 92801

  • Novo Nordisk Investigational Site

    Chesterfield, Missouri, 63017

  • Novo Nordisk Investigational Site

    Chicago, Illinois, 60607

  • Novo Nordisk Investigational Site

    Clearwater, Florida, 33765

  • Novo Nordisk Investigational Site

    Crestview Hills, Kentucky, 41017-3464

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75230

  • Novo Nordisk Investigational Site

    Golden, Colorado, 80401

  • Novo Nordisk Investigational Site

    Jackson, Tennessee, 38305

  • Novo Nordisk Investigational Site

    Kenosha, Wisconsin, 53142

  • Novo Nordisk Investigational Site

    Lomita, California, 90717

  • Novo Nordisk Investigational Site

    Los Angeles, California, 90057

  • Novo Nordisk Investigational Site

    Metairie, Louisiana, 70002

  • Novo Nordisk Investigational Site

    Nashua, New Hampshire, 03063

  • Novo Nordisk Investigational Site

    Newport News, Virginia, 23606

  • Novo Nordisk Investigational Site

    Simpsonville, South Carolina, 29681

  • Novo Nordisk Investigational Site

    Smithtown, New York, 11787

  • Novo Nordisk Investigational Site

    Toms River, New Jersey, 08755-8050

  • Novo Nordisk Investigational Site

    Troy, Michigan, 48098

Other trials in United States

Canada12 sites

  • Novo Nordisk Investigational Site

    Burlington, Ontario, L7M 4Y1

  • Novo Nordisk Investigational Site

    Burnaby, British Columbia, V5G 1T4

  • Novo Nordisk Investigational Site

    Calgary, Alberta, T2N 4L7

  • Novo Nordisk Investigational Site

    London, Ontario, N5W 6A2

  • Novo Nordisk Investigational Site

    London, Ontario, N6P 1A9

  • Novo Nordisk Investigational Site

    Newmarket, Ontario, L3Y 5G8

  • Novo Nordisk Investigational Site

    Québec, Quebec, G3K 2P8

  • Novo Nordisk Investigational Site

    Sarnia, Ontario, N7T 4X3

  • Novo Nordisk Investigational Site

    Strathroy, Ontario, N7G 1Y7

  • Novo Nordisk Investigational Site

    Surrey, British Columbia, V3S 2N6

  • Novo Nordisk Investigational Site

    Trois-Rivières, Quebec, G8T7A1

  • Novo Nordisk Investigational Site

    Victoria, British Columbia, V8V 4A1

Other trials in Canada

Romania5 sites

  • Novo Nordisk Investigational Site

    Bucharest, 020614

  • Novo Nordisk Investigational Site

    Buzău, Buzău, 120203

  • Novo Nordisk Investigational Site

    Galati, 800578

  • Novo Nordisk Investigational Site

    Oradea, Bihor County, 410469

  • Novo Nordisk Investigational Site

    Sibiu, Sibiu County, 550176

Other trials in Romania

South Africa5 sites

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal, 4001

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal, 4091

  • Novo Nordisk Investigational Site

    George, Eastern Cape, 6529

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 1812

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 2193

Other trials in South Africa

Ukraine5 sites

  • Novo Nordisk Investigational Site

    Dnipro, 49005

  • Novo Nordisk Investigational Site

    Dnipro, 49038

  • Novo Nordisk Investigational Site

    Kiev, 04114

  • Novo Nordisk Investigational Site

    Mykolaiv, 54003

  • Novo Nordisk Investigational Site

    Vinnitsa, 21010

Other trials in Ukraine

Brazil3 sites

  • Novo Nordisk Investigational Site

    Porto Alegre, 90035-170

  • Novo Nordisk Investigational Site

    São Paulo, São Paulo, 01244-030

  • Novo Nordisk Investigational Site

    São Paulo, 04022-002

Other trials in Brazil

About this study

Official title: A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes (BEGIN™: ONCE)

This trial was conducted in Africa, Asia, Europe, North and South America. The aim of the trial was to compare efficacy and safety of insulin degludec and insulin glargine in insulin naïve subjects with type 2 diabetes.

Being tested
Insulin Degludec, Insulin Glargine
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

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

  • Insulin DegludecDrug

    Also called NN1250

    Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.

  • Insulin GlargineDrug

    Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.

Study groups in NCT01849289
Study groupRoleWhat they receive
Insulin DegludecExperimentalNot described
Receives: Drug: Insulin Degludec
Insulin GlargineExperimentalNot described
Receives: Drug: Insulin Glargine

What is being measured

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

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

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

    Measured: Week 0, week 26

Secondary outcomes (5)

  1. Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes

    Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed PG value of less than 3.1 mmol/L (56 mg/dL).Minor hypoglycaemic episode is defined as an episode with symptoms consistent with hypoglycaemia with confirmation by full blood glucose < 2.8 mmol/L (50 mg/dL), or PG < 3.1 mmol/L (56 mg/dL) and which is handled by the subject himself/herself or any asymptomatic full blood glucose value < 2.8 mmol/L (50 mg/dL) or PG value < 3.1 mmol/L (56 mg/dL).

    Measured: On or after the first day of exposure to randomised trial drug (week 0) and no later than 7 days after last exposure to randomised trial drug (week 27)

  2. Change From Baseline in FPG (Fasting Plasma Glucose) (Analysed by Central Laboratory)

    Change from baseline in FPG after 26 weeks of treatment.

    Measured: Week 0, week 26

  3. Within-subject Variability as Measured by Coefficient of Variation (CV%) in Pre-breakfast SMPG (Self-measured Plasma Glucose)

    Within subject Coefficient of variation(CV[%]) in pre-breakfast self measured plasma glucose for dose adjustment after 26 treatment weeks are displayed below.

    Measured: Week 26

  4. Responder for HbA1c (Below 7.0%) at End of Trial Without Severe and Minor Hypoglycaemic Episodes

    A responder for HbA1c without severe or confirmed hypoglycaemia is defined as a subject, who meets the HbA1c target at end of trial without treatment emergent severe or confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days from last treatment.

    Measured: Week 26

  5. Number of Treatment Emergent AEs (Adverse Events)

    Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)

    Measured: On or after the first day of exposure to randomised trial drug (week 0) and no later than seven days after last exposure to randomised trial drug (week 27)

Timeline

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

  1. First posted8 May 2013 (estimated)
  2. Study start2 Jun 2013
  3. Primary completion15 May 2014
  4. Study completion15 May 2014

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
833 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01849289
Sponsor's protocol ID
NN1250-3587
Other IDs
U1111-1121-5325
Acronym
BEGIN™
Status last verified
Mar 2017
First submitted
6 May 2013
Last updated
7 Apr 2017
Data monitoring committee
No

Publications

  • Pan C, Gross JL, Yang W, Lv X, Sun L, Hansen CT, Xu H, Wagner R. A Multinational, Randomized, Open-label, Treat-to-Target Trial Comparing Insulin Degludec and Insulin Glargine in Insulin-Naive Patients with Type 2 Diabetes Mellitus. Drugs R D. 2016 Jun;16(2):239-49. doi: 10.1007/s40268-016-0134-z.

    PubMed 27098525

  • Mu YM, Guo LX, Li L, Li YM, Xu XJ, Li QM, Xu MT, Zhu LY, Yuan GY, Liu Y, Xu C, Wang ZJ, Shen FX, Luo Y, Liu JY, Li QF, Wang WH, Lai XY, Xu HF, Pan CY. [The efficacy and safety of insulin degludec versus insulin glargine in insulin-naive subjects with type 2 diabetes: results of a Chinese cohort from a multinational randomized controlled trial]. Zhonghua Nei Ke Za Zhi. 2017 Sep 1;56(9):660-666. doi: 10.3760/cma.j.issn.0578-1426.2017.09.008. Chinese.

    PubMed 28870034

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin Degludec and Insulin Glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 81 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 5 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 7 Apr 2017. 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 China, United States, Canada, Romania, South Africa 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 14 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 (%) (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 NCT01849289, 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 7 Apr 2017.

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