DiabetesPhase 3BEGIN™NCT01068678

Comparison of NN1250 With Insulin Glargine in 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 99 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 Africa, Asia, Europe, and North America. The aim of this clinical trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes currently treated with metformin alone or with metformin combined with an oral… 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: 460 participants
Where: 99 sitesin 8 countries
Study dates: Feb 2010to Nov 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

Insulin naïve subject (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 insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least three months prior to Visit 1 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 secretaguogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
Body Mass Index (BMI) below or equal to 45.0 kg/m^2

Who cannot join

Use within the last 3 months prior to Visit 1 of: thiazoledinediones, exenatide or liraglutide
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 at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for UK: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods)
Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)

Trial locations and contacts

99 sites in 8 countries.

Country

City, postcode or hospital

99 sites in 8 countries

United States57 sites

Novo Nordisk Investigational Site
Amarillo, Texas, 79106
Novo Nordisk Investigational Site
Arlington, Texas, 76014-2010
Novo Nordisk Investigational Site
Atlanta, Georgia, 30318
Novo Nordisk Investigational Site
Avon, Indiana, 46123
Novo Nordisk Investigational Site
Billings, Montana, 59101
Novo Nordisk Investigational Site
Canton, Ohio, 44718
Novo Nordisk Investigational Site
Charleston, South Carolina, 29455
Novo Nordisk Investigational Site
Chesterfield, Missouri, 63017
Novo Nordisk Investigational Site
City of Saint Peters, Missouri, 63376
Novo Nordisk Investigational Site
Cleveland, Ohio, 44115
Novo Nordisk Investigational Site
Columbus, Georgia, 31909
Novo Nordisk Investigational Site
Dallas, Texas, 75231
Novo Nordisk Investigational Site
Dayton, Ohio, 45439
Novo Nordisk Investigational Site
Des Moines, Iowa, 50314
Novo Nordisk Investigational Site
Durham, North Carolina, 27710
Novo Nordisk Investigational Site
Fishers, Indiana, 46038-1862
Novo Nordisk Investigational Site
Fort Worth, Texas, 76113
Novo Nordisk Investigational Site
Franklin, Indiana, 46131-9121
Novo Nordisk Investigational Site
Fredericksburg, Virginia, 22408-2674
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
Novo Nordisk Investigational Site
Hamilton, New Jersey, 08619
Novo Nordisk Investigational Site
Houston, Texas, 77074
Novo Nordisk Investigational Site
Houston, Texas, 77095
Novo Nordisk Investigational Site
Hyattsville, Maryland, 20782
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46254
Novo Nordisk Investigational Site
Interlochen, Michigan, 49643
Novo Nordisk Investigational Site
Irving, Texas, 75061-2210
Novo Nordisk Investigational Site
Jackson, Mississippi, 39216
Novo Nordisk Investigational Site
Lexington, Kentucky, 40503
Novo Nordisk Investigational Site
Lincoln, Nebraska, 68521
Novo Nordisk Investigational Site
Melbourne, Florida, 32901
Novo Nordisk Investigational Site
Menomonee Falls, Wisconsin, 53051-4049
Novo Nordisk Investigational Site
Mentor, Ohio, 44060
Novo Nordisk Investigational Site
Muncie, Indiana, 47304
Novo Nordisk Investigational Site
Nashville, Tennessee, 37203
Novo Nordisk Investigational Site
Northridge, California, 91325
Novo Nordisk Investigational Site
Olympia Fields, Illinois, 60461
Novo Nordisk Investigational Site
Paducah, Kentucky, 42003
Novo Nordisk Investigational Site
Palm Springs, California, 92262
Novo Nordisk Investigational Site
Paramount, California, 90723
Novo Nordisk Investigational Site
Perry, Georgia, 31069
Novo Nordisk Investigational Site
Plano, Texas, 75024
Novo Nordisk Investigational Site
Pottstown, Pennsylvania, 19464
Novo Nordisk Investigational Site
Richmond, Virginia, 23225-4017
Novo Nordisk Investigational Site
Rockville, Maryland, 20852
Novo Nordisk Investigational Site
Salt Lake City, Utah, 84107
Novo Nordisk Investigational Site
San Antonio, Texas, 78224
Novo Nordisk Investigational Site
Santa Ana, California, 92704
Novo Nordisk Investigational Site
Simpsonville, South Carolina, 29681
Novo Nordisk Investigational Site
Spring Valley, California, 91978
Novo Nordisk Investigational Site
Syracuse, New York, 13210
Novo Nordisk Investigational Site
Toms River, New Jersey, 08755-8050
Novo Nordisk Investigational Site
Tustin, California, 92780
Novo Nordisk Investigational Site
Upper St.Clair, Pennsylvania, 15241
Novo Nordisk Investigational Site
Virginia Beach, Virginia, 23462
Novo Nordisk Investigational Site
West Seneca, New York, 14224
Novo Nordisk Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Canada15 sites

Novo Nordisk Investigational Site
Calgary, Alberta, T3C 3P1
Novo Nordisk Investigational Site
Edmonton, Alberta, T5J 3N4
Novo Nordisk Investigational Site
Greater Sudbury, Ontario, P3E 1Y8
Novo Nordisk Investigational Site
Halifax, Nova Scotia, B3H 2Y9
Novo Nordisk Investigational Site
London, Ontario, N6A 4V2
Novo Nordisk Investigational Site
Mirabel, Quebec, J7J 2K8
Novo Nordisk Investigational Site
Mississauga, Ontario, L5M 2V8
Novo Nordisk Investigational Site
Sarnia, Ontario, N7T 4X3
Novo Nordisk Investigational Site
Sherbrooke, Quebec, J1G 5K2
Novo Nordisk Investigational Site
St. John's, Newfoundland and Labrador, A1A 3R5
Novo Nordisk Investigational Site
St. John's, A1B 3V6
Novo Nordisk Investigational Site
Toronto, Ontario, M3J 1N2
Novo Nordisk Investigational Site
Toronto, Ontario, M4N 3M5
Novo Nordisk Investigational Site
Toronto, Ontario, M4P 1P2
Novo Nordisk Investigational Site
Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

United Kingdom9 sites

Novo Nordisk Investigational Site
Aberdeen, AB25 1LD
Novo Nordisk Investigational Site
Aldershot, GU12 5BA
Novo Nordisk Investigational Site
Birmingham, B9 5SS
Novo Nordisk Investigational Site
Chippenham, SN15 2SB
Novo Nordisk Investigational Site
Exeter, EX2 5AX
Novo Nordisk Investigational Site
Guildford, GU2 7XX
Novo Nordisk Investigational Site
Nuneaton, CV10 7DJ
Novo Nordisk Investigational Site
Portsmouth, PO6 3LY
Novo Nordisk Investigational Site
Watford, WD18 0HB

Other trials in United Kingdom

Czechia5 sites

Novo Nordisk Investigational Site
Brandýs nad Labem, 250 01
Novo Nordisk Investigational Site
Mladá Boleslav, 293 50
Novo Nordisk Investigational Site
Ostrava, 707 02
Novo Nordisk Investigational Site
Prague, 120 00
Novo Nordisk Investigational Site
Trutnov, 541 01

Other trials in Czechia

Israel5 sites

Novo Nordisk Investigational Site
Petah Tikva, 49372
Novo Nordisk Investigational Site
Rehovot, 76100
Novo Nordisk Investigational Site
Rishon LeZiyyon, 75650
Novo Nordisk Investigational Site
Safed, 13100
Novo Nordisk Investigational Site
Tel HaShomer, 52621

Other trials in Israel

Slovakia5 sites

Novo Nordisk Investigational Site
Bratislava, 811 08
Novo Nordisk Investigational Site
Košice, 04-001
Novo Nordisk Investigational Site
Moldava nad Bodvou, 045 01
Novo Nordisk Investigational Site
Nové Zámky, 940 59
Novo Nordisk Investigational Site
Prešov, 080 01

Other trials in Slovakia

South Africa2 sites

Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4091
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 2198

Other trials in South Africa

Puerto Rico1 site

Novo Nordisk Investigational Site
Manati, 00674

Other trials in Puerto Rico

About this study

Official title: A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: EASY AM)

Conditions: Diabetes, Diabetes Mellitus, Type 2
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
Injected subcutaneously (under the skin) three times weekly. Dose was individually adjusted.
insulin glargineDrug
Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.

Study groups in NCT01068678
Study group	Role	What they receive
IDeg 3 times weekly (3TW)	Experimental	Not described Receives: Drug: insulin degludec
IGlar OD	Active comparator	Not described Receives: Drug: insulin glargine

What is being measured

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

Change in Glycosylated Haemoglobin (HbA1c)
Change from baseline in HbA1c after week 26
Measured: Week 26

Secondary outcomes (1)

Change in Body Weight
Change from baseline in body weight after week 26
Measured: Week 26

Timeline

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

Feb 2010Nov 2010

First posted15 Feb 2010 (estimated)
Study startFeb 2010
Primary completionNov 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 460 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01068678
Sponsor's protocol ID: NN1250-3724
Other IDs: 2009-011398-33, U1111-1113-2412, 2009
Acronym: BEGIN™
Status last verified: Jan 2017
First submitted: 12 Feb 2010
Last updated: 6 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Zinman B, DeVries JH, Bode B, Russell-Jones D, Leiter LA, Moses A, Johansen T, Ratner R; NN1250-3724 (BEGIN:EASY AM) and NN1250-3718 (BEGIN:EASY PM) Trial Investigators. Efficacy and safety of insulin degludec three times a week versus insulin glargine once a day in insulin-naive patients with type 2 diabetes: results of two phase 3, 26 week, randomised, open-label, treat-to-target, non-inferiority trials. Lancet Diabetes Endocrinol. 2013 Oct;1(2):123-31. doi: 10.1016/S2213-8587(13)70013-5. Epub 2013 Jul 9.
PubMed 24622318

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: EASY AM)
ClinicalTrials.gov ID: NCT01068678
Acronym / sponsor ID: BEGIN™ / NN1250-3724
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 460 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 15 Feb 2010 (estimated)
Results: Posted 28 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
IDeg 3 times weekly (3TW)	Experimental	Drug: insulin degludec
IGlar OD	Active comparator	Drug: insulin glargine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Insulin naïve subject (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 insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least three months prior to Visit 1 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 secretaguogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
Body Mass Index (BMI) below or equal to 45.0 kg/m^2

Key exclusion criteria (5 listed)

Use within the last 3 months prior to Visit 1 of: thiazoledinediones, exenatide or liraglutide
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 at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for UK: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods)
Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
insulin degludecInjected subcutaneously (under the skin) three times weekly. Dose was individually adjusted.	Drug	IDeg 3 times weekly (3TW)
insulin glargineInjected subcutaneously (under the skin) once daily. Dose was individually adjusted.	Drug	IGlar OD

Primary outcome

Change in Glycosylated Haemoglobin (HbA1c)
Time frame: Week 26
Change from baseline in HbA1c after week 26

1 secondary outcome

Change in Body Weight
Time frame: Week 26

Results and safety

Results posted to the registry on 28 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IDeg 3TW	230	192
IGlar OD	230	206

Primary outcome: Change in Glycosylated Haemoglobin (HbA1c)

Time frame: Week 26. Mean (Standard Deviation). Unit: percentage of glycosylated haemoglobin

Measure	IDeg 3TW n = 229	IGlar OD n = 230
Value	-1.00 (0.95)	-1.40 (1.07)

Population analysed: The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).1 subject was randomised despite being a screening failure.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected in a time frame of 26 weeks + 7 days follow up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IDeg 3TW	11 of 227 (4.8%)	69 of 227 (30.4%)	Not reported
IGlar OD	4 of 229 (1.7%)	77 of 229 (33.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24622318Zinman B, DeVries JH, Bode B, Russell-Jones D, Leiter LA, Moses A, Johansen T, Ratner R; NN1250-3724 (BEGIN:EASY AM) and NN1250-3718 (BEGIN:EASY PM) Trial Investigators. Efficacy and safety of insulin degludec three times a week versus insulin glargine once a day in insulin-naive patients with type 2 diabetes: results of two phase 3, 26 week, randomised, open-label, treat-to-target, non-inferiority trials. Lancet Diabetes Endocrinol. 2013 Oct;1(2):123-31. doi: 10.1016/S2213-8587(13)70013-5. Epub 2013 Jul 9.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

99 sites in 8 countries: see every site and its status.

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 99 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 4 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 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 99 sites in United States, Canada, United Kingdom, Czechia, Israel 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 28 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?

Change in Glycosylated Haemoglobin (HbA1c) (time frame: 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 NCT01068678, which also lists 1 linked publication.

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.