DiabetesPhase 3BEGIN™NCT01046110

Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin

A Phase 3 study testing insulin degludec and sitagliptin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 93 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 will be conducted in Africa, Asia, North America and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec) with sitagliptin, as add-on to subject's own current oral antidiabetic (OAD) treatment, in subjects with type 2 diabetes inadequately controlled with 1-2 OADs… 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 sitagliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 458 participants
Where: 93 sitesin 7 countries
Study dates: Jan 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

Type 2 diabetes (diagnosed clinically) for at least 6 months
Ongoing treatment with 1 or 2 of the following OADs (metformin, insulin secretagogue (sulphonylurea or glinides) or pioglitazone) in any combination with unchanged dosing for at least 3 months prior to Visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination)1500 mg or maximum tolerated dose (at least 1000 mg daily) -Insulin secretagogue (sulfonylurea or glinide): minimum half of the maximal daily dose according to local labelling -Pioglitazone: minimum half of the maximal daily dose according to local labelling or maximum tolerated dose
Body Mass Index (BMI) below or equal to 40.0 kg/m^2
HbA1c 7.5-11.0 % (both inclusive) by central laboratory analysis

Who cannot join

Use within the last 3 months prior to Visit 1 of: exenatide, liraglutide, rosiglitazone or acarbose
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)
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
Cancer and medical history hereof (except basal cell skin cancer or squamous cell skin cancer)

Trial locations and contacts

93 sites in 7 countries.

Country

City, postcode or hospital

93 sites in 7 countries

United States57 sites

Novo Nordisk Investigational Site
Albuquerque, New Mexico, 87108
Novo Nordisk Investigational Site
Albuquerque, New Mexico, 87131
Novo Nordisk Investigational Site
Brockton, Massachusetts, 02301
Novo Nordisk Investigational Site
Charleston, South Carolina, 29401
Novo Nordisk Investigational Site
Chicago, Illinois, 60611
Novo Nordisk Investigational Site
Chicago, Illinois, 60624
Novo Nordisk Investigational Site
Clearwater, Florida, 33765
Novo Nordisk Investigational Site
Columbus, Georgia, 31904
Novo Nordisk Investigational Site
Concord, California, 94520
Novo Nordisk Investigational Site
Corpus Christi, Texas, 78404
Novo Nordisk Investigational Site
Council Bluffs, Iowa, 51501
Novo Nordisk Investigational Site
Decatur, Georgia, 30033
Novo Nordisk Investigational Site
Denver, Colorado, 80239-3133
Novo Nordisk Investigational Site
Des Moines, Iowa, 50314-2610
Novo Nordisk Investigational Site
Dunwoody, Georgia, 30338
Novo Nordisk Investigational Site
Durham, North Carolina, 27710
Novo Nordisk Investigational Site
El Paso, Texas, 79905-2709
Novo Nordisk Investigational Site
El Paso, Texas, 79912
Novo Nordisk Investigational Site
Fresno, California, 93720
Novo Nordisk Investigational Site
Greenbrae, California, 94904
Novo Nordisk Investigational Site
Greenville, North Carolina, 27834-5784
Novo Nordisk Investigational Site
Houston, Texas, 77070
Novo Nordisk Investigational Site
Huntington, Indiana, 46750-1404
Novo Nordisk Investigational Site
Huntsville, Alabama, 35801
Novo Nordisk Investigational Site
Inverness, Florida, 34452
Novo Nordisk Investigational Site
Jackson, Mississippi, 39216
Novo Nordisk Investigational Site
Kissimmee, Florida, 34741
Novo Nordisk Investigational Site
La Jolla, California, 92037
Novo Nordisk Investigational Site
Livonia, Michigan, 48152-3501
Novo Nordisk Investigational Site
Long Beach, California, 90806
Novo Nordisk Investigational Site
Metairie, Louisiana, 70002
Novo Nordisk Investigational Site
Miami, Florida, 33125-1655
Novo Nordisk Investigational Site
Miami, Florida, 33135
Novo Nordisk Investigational Site
Miami, Florida, 33186
Novo Nordisk Investigational Site
Mission Hills, California, 91345
Novo Nordisk Investigational Site
Murrells Inlet, South Carolina, 29576
Novo Nordisk Investigational Site
New Hyde Park, New York, 11042
Novo Nordisk Investigational Site
Ocala, Florida, 34471
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, 73104
Novo Nordisk Investigational Site
Paducah, Kentucky, 42003
Novo Nordisk Investigational Site
Palm Springs, California, 92262
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15224-2215
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15241
Novo Nordisk Investigational Site
Ponte Vedra, Florida, 32081
Novo Nordisk Investigational Site
Roswell, Georgia, 30076
Novo Nordisk Investigational Site
Saint Paul, Minnesota, 55108
Novo Nordisk Investigational Site
Salt Lake City, Utah, 84107
Novo Nordisk Investigational Site
Spokane, Washington, 99208
Novo Nordisk Investigational Site
Springfield, Illinois, 62711
Novo Nordisk Investigational Site
Sugar Land, Texas, 77478
Novo Nordisk Investigational Site
Tampa, Florida, 33603
Novo Nordisk Investigational Site
Tomball, Texas, 77375
Novo Nordisk Investigational Site
Torrance, California, 90504
Novo Nordisk Investigational Site
Troy, Michigan, 48085-5524
Novo Nordisk Investigational Site
Virginia Beach, Virginia, 23454
Novo Nordisk Investigational Site
Walnut Creek, California, 94598-3347
Novo Nordisk Investigational Site
West Seneca, New York, 14224

Other trials in United States

Canada11 sites

Novo Nordisk Investigational Site
Cambridge, Ontario, N1R 7L6
Novo Nordisk Investigational Site
Chatham, Ontario, N7L 1C1
Novo Nordisk Investigational Site
Gatineau, Quebec, J8V 2P5
Novo Nordisk Investigational Site
Laval, Quebec, H7T 2P5
Novo Nordisk Investigational Site
London, Ontario, N6H 4P2
Novo Nordisk Investigational Site
London, Ontario, N6P 1A9
Novo Nordisk Investigational Site
Montreal, Quebec, H3J 2V5
Novo Nordisk Investigational Site
Saint-Marc-des-Carrieres, Quebec, G0A 4B0
Novo Nordisk Investigational Site
Smiths Falls, Ontario, K7A 4W8
Novo Nordisk Investigational Site
St. Catharines, Ontario, L2N 7H8
Novo Nordisk Investigational Site
Surrey, British Columbia, V3S 2N6

Other trials in Canada

India9 sites

Novo Nordisk Investigational Site
Bangalore, Karnataka, 560 003
Novo Nordisk Investigational Site
Bangalore, Karnataka, BANGALORE
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, 600029
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, 500 001
Novo Nordisk Investigational Site
Madurai, Tamil Nadu, 625 020
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400008
Novo Nordisk Investigational Site
Nagpur, 440012
Novo Nordisk Investigational Site
Pune, 411005
Novo Nordisk Investigational Site
Pune, 411011

Other trials in India

Argentina6 sites

Novo Nordisk Investigational Site
Buenos Aires, C1181ACH
Novo Nordisk Investigational Site
Caba, C1440AAD
Novo Nordisk Investigational Site
Ciudad Autónoma de BsAs, C1406FWY
Novo Nordisk Investigational Site
Córdoba, 5000
Novo Nordisk Investigational Site
Mar del Plata, B7602CBM
Novo Nordisk Investigational Site
Mendoza, 5500

Other trials in Argentina

Turkey (Türkiye)5 sites

Novo Nordisk Investigational Site
Ankara, 06100
Novo Nordisk Investigational Site
Denizli, 20070
Novo Nordisk Investigational Site
Istanbul, 34098
Novo Nordisk Investigational Site
Istanbul, 34390
Novo Nordisk Investigational Site
Izmir, 35340

Other trials in Turkey (Türkiye)

South Africa3 sites

Novo Nordisk Investigational Site
Cape Town, Western Cape, 7460
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4001
Novo Nordisk Investigational Site
Umhlanga, 4320

Other trials in South Africa

Mexico2 sites

Novo Nordisk Investigational Site
Guadalajara, 44600
Novo Nordisk Investigational Site
Mexico City, 11850

Other trials in Mexico

About this study

Official title: A Trial Comparing Efficacy and Safety of NN1250 With Sitagliptin in Insulin Naive Subjects With Type 2 Diabetes (BEGIN™ : EARLY)

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin degludec, sitagliptin
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 under the skin once daily for 26 weeks. The doses will be individually adjusted.
sitagliptinDrug
Sitagliptin tablets administered orally once a day at the same time every day for 26 weeks

Study groups in NCT01046110
Study group	Role	What they receive
IDeg OD	Experimental	Not described Receives: Drug: insulin degludec
DPP-IV inhibitor	Experimental	Not described Receives: Drug: sitagliptin

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 26 weeks of treatment
Measured: Week 0, Week 26

Secondary outcomes (1)

Change in Fasting Plasma Glucose (FPG)
Change from baseline in FPG after 26 weeks of treatment
Measured: Week 0, Week 26

Timeline

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

Jan 2010Nov 2010

First posted11 Jan 2010 (estimated)
Study startJan 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: 458 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01046110
Sponsor's protocol ID: NN1250-3580
Other IDs: U1111-1111-7126
Acronym: BEGIN™
Status last verified: Jan 2017
First submitted: 8 Jan 2010
Last updated: 3 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Philis-Tsimikas A, Del Prato S, Satman I, Bhargava A, Dharmalingam M, Skjoth TV, Rasmussen S, Garber AJ. Effect of insulin degludec versus sitagliptin in patients with type 2 diabetes uncontrolled on oral antidiabetic agents. Diabetes Obes Metab. 2013 Aug;15(8):760-6. doi: 10.1111/dom.12115. Epub 2013 May 6.
PubMed 23577643

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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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 3 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 With Sitagliptin in Insulin Naive Subjects With Type 2 Diabetes (BEGIN™ : EARLY)
ClinicalTrials.gov ID: NCT01046110
Acronym / sponsor ID: BEGIN™ / NN1250-3580
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 458 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 11 Jan 2010 (estimated)
Results: Posted 18 Nov 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 OD	Experimental	Drug: insulin degludec
DPP-IV inhibitor	Experimental	Drug: sitagliptin

Who may qualify

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

Key inclusion criteria (4 listed)

Type 2 diabetes (diagnosed clinically) for at least 6 months
Ongoing treatment with 1 or 2 of the following OADs (metformin, insulin secretagogue (sulphonylurea or glinides) or pioglitazone) in any combination with unchanged dosing for at least 3 months prior to Visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination)1500 mg or maximum tolerated dose (at least 1000 mg daily) -Insulin secretagogue (sulfonylurea or glinide): minimum half of the maximal daily dose according to local labelling -Pioglitazone: minimum half of the maximal daily dose according to local labelling or maximum tolerated dose
Body Mass Index (BMI) below or equal to 40.0 kg/m^2
HbA1c 7.5-11.0 % (both inclusive) by central laboratory analysis

Key exclusion criteria (6 listed)

Use within the last 3 months prior to Visit 1 of: exenatide, liraglutide, rosiglitazone or acarbose
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)
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate

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 under the skin once daily for 26 weeks. The doses will be individually adjusted.	Drug	IDeg OD
sitagliptinSitagliptin tablets administered orally once a day at the same time every day for 26 weeks	Drug	DPP-IV inhibitor

Primary outcome

Change in Glycosylated Haemoglobin (HbA1c)
Time frame: Week 0, Week 26
Change from baseline in HbA1c after 26 weeks of treatment

1 secondary outcome

Change in Fasting Plasma Glucose (FPG)
Time frame: Week 0, Week 26

Results and safety

Results posted to the registry on 18 Nov 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 OD	229	174
DPP-IV Inhibitor	229	174

Primary outcome: Change in Glycosylated Haemoglobin (HbA1c)

Time frame: Week 0, Week 26. Mean (Standard Deviation). Unit: percentage of glycosylated haemoglobin

Measure	IDeg OD n = 225	DPP-IV Inhibitor n = 222
Value	-1.56 (1.09)	-1.22 (1.16)

Population analysed: The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). A site was closed, hence 11 randomised subjects (4 subjects with IDeg; 7 subjects with DPP-IV group/arm) were excluded from the FAS.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: The 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 OD	14 of 226 (6.2%)	44 of 226 (19.5%)	Not reported
DPP-IV Inhibitor	10 of 228 (4.4%)	53 of 228 (23.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23577643Philis-Tsimikas A, Del Prato S, Satman I, Bhargava A, Dharmalingam M, Skjoth TV, Rasmussen S, Garber AJ. Effect of insulin degludec versus sitagliptin in patients with type 2 diabetes uncontrolled on oral antidiabetic agents. Diabetes Obes Metab. 2013 Aug;15(8):760-6. doi: 10.1111/dom.12115. Epub 2013 May 6.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
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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

93 sites in 7 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 sitagliptin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 93 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 4 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 3 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 93 sites in United States, Canada, India, Argentina, Turkey (Türkiye) 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 18 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?

Change in Glycosylated Haemoglobin (HbA1c) (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 NCT01046110, 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 3 Mar 2017.