DiabetesPhase 3BEGIN™NCT01326026

Comparing the Efficacy and Safety of NN1250 Once Daily When Titrated Using 2 Different Algorithms in Insulin naïve Subjects With Type 2 Diabetes Mellitus

A Phase 3 study testing insulin degludec in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 45 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) once daily in insulin naïve subjects with type 2 diabetes mellitus when titrated using two different self-titration algorithms (dose individually… 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
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 222 participants
Where: 45 sitesin 4 countries
Study dates: Mar 2011to Dec 2011
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 24 weeks prior to randomisation (Visit 2)
Current treatment: metformin monotherapy or metformin in any combination with 1 or 2 other OADs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones (TZDs) all with unchanged dosing for at least 12 weeks prior to randomisation (Visit 2)-metformin: alone or in combination (including fixed combination) must be at least 1000 mg daily
HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
BMI (Body Mass Index) no higher than 45.0 kg/m^2

Who cannot join

Treatment with glucagon-like peptide 1 (GLP-1) receptor agonist within the last 12 weeks prior to Visit 2
Suffer from a life threatening disease (e.g. cancer)
Females of childbearing potential who are pregnant (as determined by central laboratory beta-human chorionic gonadotropin (beta-hCG), breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods as required by law or practise [for Germany, adequate contraceptive methods are: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner])

Trial locations and contacts

45 sites in 4 countries.

Country

City, postcode or hospital

45 sites in 4 countries

United States27 sites

Novo Nordisk Investigational Site
Anaheim, California, 92801
Novo Nordisk Investigational Site
Billings, Montana, 59102
Novo Nordisk Investigational Site
Birmingham, Alabama, 35216
Novo Nordisk Investigational Site
Columbus, Georgia, 31909
Novo Nordisk Investigational Site
East Providence, Rhode Island, 02914
Novo Nordisk Investigational Site
Evansville, Indiana, 47714
Novo Nordisk Investigational Site
Franklin, Ohio, 45005
Novo Nordisk Investigational Site
Golden, Colorado, 80401
Novo Nordisk Investigational Site
Greensboro, North Carolina, 27408
Novo Nordisk Investigational Site
Houston, Texas, 77095
Novo Nordisk Investigational Site
Humboldt, Tennessee, 38343
Novo Nordisk Investigational Site
Huntsville, Alabama, 35801
Novo Nordisk Investigational Site
Killeen, Texas, 76543-5600
Novo Nordisk Investigational Site
Kissimmee, Florida, 34741
Novo Nordisk Investigational Site
La Jolla, California, 92037
Novo Nordisk Investigational Site
Melrose Park, Pennsylvania, 19027
Novo Nordisk Investigational Site
Mission Hills, California, 91345
Novo Nordisk Investigational Site
National City, California, 91950
Novo Nordisk Investigational Site
North Hollywood, California, 91606
Novo Nordisk Investigational Site
Ogden, Utah, 84403
Novo Nordisk Investigational Site
San Antonio, Texas, 78224
Novo Nordisk Investigational Site
San Diego, California, 92111
Novo Nordisk Investigational Site
Slidell, Louisiana, 70461-4231
Novo Nordisk Investigational Site
Springfield, Illinois, 62711
Novo Nordisk Investigational Site
St. George, Utah, 84790
Novo Nordisk Investigational Site
Staten Island, New York, 10301
Novo Nordisk Investigational Site
Tampa, Florida, 33603

Other trials in United States

Spain7 sites

Novo Nordisk Investigational Site
Almería, 04001
Novo Nordisk Investigational Site
Antequera, 29200
Novo Nordisk Investigational Site
Gijón, 33206
Novo Nordisk Investigational Site
Málaga, 29006
Novo Nordisk Investigational Site
Palma de Mallorca, 07014
Novo Nordisk Investigational Site
Palma de Mallorca, 07198
Novo Nordisk Investigational Site
Pozuelo de Alarcón, 28223

Other trials in Spain

Germany6 sites

Novo Nordisk Investigational Site
Berlin, 12163
Novo Nordisk Investigational Site
Friedrichsthal, 66299
Novo Nordisk Investigational Site
Hohenmölsen, 06679
Novo Nordisk Investigational Site
Münster, 48145
Novo Nordisk Investigational Site
Neuwied, 56564
Novo Nordisk Investigational Site
Völklingen, 66333

Other trials in Germany

Finland5 sites

Novo Nordisk Investigational Site
Helsinki, 00260
Novo Nordisk Investigational Site
Kerava, FI-04200
Novo Nordisk Investigational Site
Tampere, 33210
Novo Nordisk Investigational Site
Turku, 20520
Novo Nordisk Investigational Site
Turku, FI-20100

Other trials in Finland

About this study

Official title: A Trial Comparing the Efficacy and Safety of Insulin Degludec Once Daily in Insulin naïve Subjects With Type 2 Diabetes Mellitus When Titrated Using Two Different Titration Algorithms (BEGIN™: ONCE SIMPLE USE)

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin degludec
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) once daily. Dose individually adjusted.
insulin degludecDrug
Injected subcutaneously (under the skin) once daily. Dose individually adjusted in a stepwise manner.

Study groups in NCT01326026
Study group	Role	What they receive
IDeg Simple	Experimental	Not described Receives: Drug: insulin degludec
IDeg Step wise	Experimental	Not described Receives: Drug: insulin degludec

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 (4)

Change in Fasting Plasma Glucose (FPG)
Change from baseline in FPG after 26 weeks of treatment.
Measured: Week 0, Week 26
Rate of Treatment Emergent Adverse Events (AEs)
Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or 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.
Measured: Week 0 to Week 26 + 7 days follow up
Rate of Confirmed Hypoglycaemic Episodes
Observed 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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Measured: Week 0 to Week 26 + 7 days follow up
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Observed rate of nocturnal 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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Measured: Week 0 to Week 26 + 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.

Mar 2011Dec 2011

First posted30 Mar 2011 (estimated)
Study startMar 2011
Primary completionDec 2011
Study completionDec 2011

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: 222 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01326026
Sponsor's protocol ID: NN1250-3846
Other IDs: U1111-1117-0616, 2010-022337-29
Acronym: BEGIN™
Status last verified: Jan 2017
First submitted: 29 Mar 2011
Last updated: 6 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Philis-Tsimikas A, Brod M, Niemeyer M, Ocampo Francisco AM, Rothman J. Insulin degludec once-daily in type 2 diabetes: simple or step-wise titration (BEGIN: once simple use). Adv Ther. 2013 Jun;30(6):607-22. doi: 10.1007/s12325-013-0036-1. Epub 2013 Jun 29.
PubMed 23812875

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 the Efficacy and Safety of Insulin Degludec Once Daily in Insulin naïve Subjects With Type 2 Diabetes Mellitus When Titrated Using Two Different Titration Algorithms (BEGIN™: ONCE SIMPLE USE)
ClinicalTrials.gov ID: NCT01326026
Acronym / sponsor ID: BEGIN™ / NN1250-3846
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 222 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 30 Mar 2011 (estimated)
Results: Posted 17 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 Simple	Experimental	Drug: insulin degludec
IDeg Step wise	Experimental	Drug: insulin degludec

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 24 weeks prior to randomisation (Visit 2)
Current treatment: metformin monotherapy or metformin in any combination with 1 or 2 other OADs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones (TZDs) all with unchanged dosing for at least 12 weeks prior to randomisation (Visit 2)-metformin: alone or in combination (including fixed combination) must be at least 1000 mg daily
HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
BMI (Body Mass Index) no higher than 45.0 kg/m^2

Key exclusion criteria (3 listed)

Treatment with glucagon-like peptide 1 (GLP-1) receptor agonist within the last 12 weeks prior to Visit 2
Suffer from a life threatening disease (e.g. cancer)
Females of childbearing potential who are pregnant (as determined by central laboratory beta-human chorionic gonadotropin (beta-hCG), breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods as required by law or practise [for Germany, adequate contraceptive methods are: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner])

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) once daily. Dose individually adjusted.	Drug	IDeg Simple
insulin degludecInjected subcutaneously (under the skin) once daily. Dose individually adjusted in a stepwise manner.	Drug	IDeg Step wise

Primary outcome

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

4 secondary outcomes

Change in Fasting Plasma Glucose (FPG)
Time frame: Week 0, Week 26
Rate of Treatment Emergent Adverse Events (AEs)
Time frame: Week 0 to Week 26 + 7 days follow up
Rate of Confirmed Hypoglycaemic Episodes
Time frame: Week 0 to Week 26 + 7 days follow up
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Time frame: Week 0 to Week 26 + 7 days follow up

Results and safety

Results posted to the registry on 17 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 Simple	111	99
IDeg Step Wise	111	98

Primary outcome: Change in Glycosylated Haemoglobin (HbA1c)

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

Measure	IDeg Simple n = 111	IDeg Step Wise n = 111
Value	-1.09 (1.05)	-0.93 (0.97)

Population analysed: The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).

4 secondary outcomes are 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 Simple	5 of 110 (4.5%)	17 of 110 (15.5%)	Not reported
IDeg Step Wise	7 of 111 (6.3%)	14 of 111 (12.6%)	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 23812875Philis-Tsimikas A, Brod M, Niemeyer M, Ocampo Francisco AM, Rothman J. Insulin degludec once-daily in type 2 diabetes: simple or step-wise titration (BEGIN: once simple use). Adv Ther. 2013 Jun;30(6):607-22. doi: 10.1007/s12325-013-0036-1. Epub 2013 Jun 29.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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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

45 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin degludec in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 45 sites in 4 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 3 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 45 sites in United States, Spain, Germany, Finland. 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 17 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 NCT01326026, 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.