DiabetesPhase 3BEGIN™NCT01388361

Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin

A Phase 3 study testing insulin degludec, insulin aspart and liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 124 sites in 12 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 Europe and North America. The aim of this trial is to compare the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec in 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, insulin aspart and liraglutide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 413 participants
Where: 124 sitesin 12 countries
Study dates: Sep 2011to Jul 2012
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

Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
The subject must have completed the end of treatment visit of NN1250-3643 with Insulin degludec once daily + metformin.
Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol

Who cannot join

Participated in NN1250-3643 and treated with insulin glargine
Previous treatment with glucacon like peptide (GLP-1) receptor agonists (e.g. exenatide, liraglutide)
Impaired liver function, defined as alanine aminotransferase (ALAT) 2.5 times the upper limit of normal at end of treatment in NN1250-3643
Impaired renal function defined as serum-creatinine = 125 µmol/l (= 1.4 mg/dl) for males and = 110 µmol/L (= 1.3 mg/dl) for females or according to local label for metformin [For France: glomerular filtration rate below 60 ml/min, calculated by the Cockroft \& Gault formula] at end of treatment in NN1250-3643.

Trial locations and contacts

124 sites in 12 countries.

Country

City, postcode or hospital

124 sites in 12 countries

United States48 sites

Novo Nordisk Investigational Site
Arlington, Texas, 76014
Novo Nordisk Investigational Site
Asheboro, North Carolina, 27203
Novo Nordisk Investigational Site
Boynton Beach, Florida, 33472
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37411
Novo Nordisk Investigational Site
Chicago, Illinois, 60607
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45245
Novo Nordisk Investigational Site
Columbia, South Carolina, 29203
Novo Nordisk Investigational Site
Concord, California, 94520-1926
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75246
Novo Nordisk Investigational Site
Decatur, Georgia, 30033
Novo Nordisk Investigational Site
East Providence, Rhode Island, 02914
Novo Nordisk Investigational Site
Evansville, Indiana, 47714
Novo Nordisk Investigational Site
Fort Worth, Texas, 76113
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
Novo Nordisk Investigational Site
Humboldt, Tennessee, 38343
Novo Nordisk Investigational Site
Irving, Texas, 75061-2210
Novo Nordisk Investigational Site
La Jolla, California, 92037
Novo Nordisk Investigational Site
Lancaster, California, 93534
Novo Nordisk Investigational Site
Los Angeles, California, 90057
Novo Nordisk Investigational Site
Lubbock, Texas, 79423
Novo Nordisk Investigational Site
Melbourne, Florida, 32901
Novo Nordisk Investigational Site
Melrose Park, Pennsylvania, 19027
Novo Nordisk Investigational Site
Metairie, Louisiana, 70002
Novo Nordisk Investigational Site
Miami, Florida, 33156
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209
Novo Nordisk Investigational Site
Nashville, Tennessee, 37203
Novo Nordisk Investigational Site
National City, California, 91950
Novo Nordisk Investigational Site
New Port Richey, Florida, 34652
Novo Nordisk Investigational Site
North East, Maryland, 21901
Novo Nordisk Investigational Site
Northport, New York, 11768
Novo Nordisk Investigational Site
Northridge, California, 91325
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, 73103
Novo Nordisk Investigational Site
Paducah, Kentucky, 42003
Novo Nordisk Investigational Site
Palm Harbor, Florida, 34684
Novo Nordisk Investigational Site
Palm Springs, California, 92262
Novo Nordisk Investigational Site
Rockville, Maryland, 20852
Novo Nordisk Investigational Site
San Antonio, Texas, 78215
Novo Nordisk Investigational Site
Santa Monica, California, 90404
Novo Nordisk Investigational Site
Slidell, Louisiana, 70461-4231
Novo Nordisk Investigational Site
Spring Valley, California, 91978
Novo Nordisk Investigational Site
Staten Island, New York, 10301
Novo Nordisk Investigational Site
Sugar Land, Texas, 77479
Novo Nordisk Investigational Site
Tarzana, California, 91356-3551
Novo Nordisk Investigational Site
Toms River, New Jersey, 08755-8050
Novo Nordisk Investigational Site
Tustin, California, 92780
Novo Nordisk Investigational Site
Upper Saint Clair, Pennsylvania, 15241
Novo Nordisk Investigational Site
West Palm Beach, Florida, 33401

Other trials in United States

Canada15 sites

Novo Nordisk Investigational Site
Coquitlam, British Columbia, V3K 3P4
Novo Nordisk Investigational Site
Edmonton, Alberta, T5J 3N4
Novo Nordisk Investigational Site
Halifax, Nova Scotia, B3K 0A4
Novo Nordisk Investigational Site
Mississauga, Ontario, L5M 2V8
Novo Nordisk Investigational Site
Mount Pearl, Newfoundland and Labrador, A1N 1W7
Novo Nordisk Investigational Site
Ottawa, Ontario, K1K 4L2
Novo Nordisk Investigational Site
Ottawa, Ontario, K1N 6N5
Novo Nordisk Investigational Site
Québec, Quebec, G1V 4G2
Novo Nordisk Investigational Site
Saint Romuald, Quebec, G6W 5M6
Novo Nordisk Investigational Site
Saint-Marc-des-Carrieres, Quebec, G0A 4B0
Novo Nordisk Investigational Site
Scarborough Village, Ontario, M1E 5E9
Novo Nordisk Investigational Site
St. John's, Newfoundland and Labrador, A1A 3R5
Novo Nordisk Investigational Site
Toronto, Ontario, M5C 2T2
Novo Nordisk Investigational Site
Vancouver, British Columbia, V5Z 1M9
Novo Nordisk Investigational Site
Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Germany13 sites

Novo Nordisk Investigational Site
Berlin, 12163
Novo Nordisk Investigational Site
Berlin, 13055
Novo Nordisk Investigational Site
Dresden, 01307
Novo Nordisk Investigational Site
Essen, 45329
Novo Nordisk Investigational Site
Friedrichsthal, 66299
Novo Nordisk Investigational Site
Hamburg, 22391
Novo Nordisk Investigational Site
Hohenmölsen, 06679
Novo Nordisk Investigational Site
Neuwied, 56564
Novo Nordisk Investigational Site
Pohlheim, 35415
Novo Nordisk Investigational Site
Rehburg-Loccum, 31547
Novo Nordisk Investigational Site
Rehlingen-Siersburg, 66780
Novo Nordisk Investigational Site
Saint Ingbert, 66386
Novo Nordisk Investigational Site
Speyer, 67346

Other trials in Germany

Norway8 sites

Novo Nordisk Investigational Site
Ålesund, 6003
Novo Nordisk Investigational Site
Bekkestua, 1357
Novo Nordisk Investigational Site
Elverum, 2408
Novo Nordisk Investigational Site
Hamar, 2318
Novo Nordisk Investigational Site
Kongsvinger, 2212
Novo Nordisk Investigational Site
Oslo, 0407
Novo Nordisk Investigational Site
Stavanger, 4011
Novo Nordisk Investigational Site
Trondheim, NO-7030

Other trials in Norway

Spain7 sites

Novo Nordisk Investigational Site
Almería, 04001
Novo Nordisk Investigational Site
Antequera, 29200
Novo Nordisk Investigational Site
Ferrol, 15405
Novo Nordisk Investigational Site
Inca, 07300
Novo Nordisk Investigational Site
Palma de Mallorca, 07014
Novo Nordisk Investigational Site
Seville, 41003
Novo Nordisk Investigational Site
Seville, 41010

Other trials in Spain

Denmark6 sites

Novo Nordisk Investigational Site
Esbjerg, 6700
Novo Nordisk Investigational Site
Hillerød, 3400
Novo Nordisk Investigational Site
Holbæk, 4300
Novo Nordisk Investigational Site
København S, 2300
Novo Nordisk Investigational Site
Odense, 5000
Novo Nordisk Investigational Site
Silkeborg, 8600

Other trials in Denmark

Finland6 sites

Novo Nordisk Investigational Site
Helsinki, 00260
Novo Nordisk Investigational Site
Joensuu, 80100
Novo Nordisk Investigational Site
Kerava, FI-04200
Novo Nordisk Investigational Site
Lohja, 08100
Novo Nordisk Investigational Site
Oulu, 90100
Novo Nordisk Investigational Site
Tampere, 33210

Other trials in Finland

Austria5 sites

Novo Nordisk Investigational Site
Feldkirch, 6807
Novo Nordisk Investigational Site
Vienna, 1030
Novo Nordisk Investigational Site
Vienna, 1090
Novo Nordisk Investigational Site
Vienna, 1130
Novo Nordisk Investigational Site
Wolfsberg, 9400

Other trials in Austria

Belgium4 sites

Novo Nordisk Investigational Site
Brussels, 1070
Novo Nordisk Investigational Site
Ghent, 9000
Novo Nordisk Investigational Site
Leuven, 3000
Novo Nordisk Investigational Site
Liège, 4000

Other trials in Belgium

Czechia4 sites

Novo Nordisk Investigational Site
Brno, 65691
Novo Nordisk Investigational Site
Hradec Králové, 500 05
Novo Nordisk Investigational Site
Pilsen, 304 60
Novo Nordisk Investigational Site
Prague, 140 21

Other trials in Czechia

France4 sites

Novo Nordisk Investigational Site
Montigny-lès-Metz, 57950
Novo Nordisk Investigational Site
Nanterre, 92014
Novo Nordisk Investigational Site
Nîmes, 30006
Novo Nordisk Investigational Site
Vénissieux, 69200

Other trials in France

Serbia4 sites

Novo Nordisk Investigational Site
Belgrade, 11000
Novo Nordisk Investigational Site
Kragujevac, 34000
Novo Nordisk Investigational Site
Niš, 18000
Novo Nordisk Investigational Site
Novi Sad, 21000

Other trials in Serbia

About this study

Official title: A Trial Comparing the Efficacy and Safety of Adding Liraglutide Versus Addition of Insulin Aspart With the Largest Meal to Insulin Degludec, Both in Combination With Metformin, in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification (BEGIN™: VICTOZA® ADD-ON)

Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643 (NCT01193309) trial will be randomised to receive treatment intensification while subjects with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to receive insulin degludec treatment. Subjects are to continue their pre-trial metformin treatment.

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin degludec, insulin aspart, liraglutide
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 s.c. (under the skin) once daily. The doses will be individually adjusted
insulin aspartDrug
Injected s.c. (under the skin) once daily. The doses will be individually adjusted.
liraglutideDrug
Injected s.c. (under the skin) once daily. The doses will be individually adjusted.

Study groups in NCT01388361
Study group	Role	What they receive
IDeg (non-randomised)	Experimental	Not described Receives: Drug: insulin degludec
IDeg + IAsp	Experimental	Not described Receives: Drug: insulin degludec; Drug: insulin aspart
IDeg + liraglutide	Experimental	Not described Receives: Drug: insulin degludec; Drug: liraglutide

What is being measured

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

Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)
Values for change in HbA1c from baseline to 26 weeks of treatment period.
Measured: week 0, week 26

Secondary outcomes (3)

Change From Baseline in Fasting Plasma Glucose (FPG)
Values for change in FPG in mmol/L from baseline to week 26 of randomised period.
Measured: week 0, week 26
Change From Baseline in Body Weight
Corresponds to the values of change in body weight in kilograms from baseline to week 26.
Measured: week 0, week 26
Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
Corresponds to number of treatment emergent hypoglycaemic events from onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product. Confirmed hypoglycaemia was defined as the pool of severe hypoglycaemic episodes and minor episodes with a plasma glucose (PG) value < 3.1 mmol/L (56 mg/dL).
Measured: Onset on or after the first day of exposure to investigational product for 26 weeks of treatment period and no later than 7 days after last exposure to investigational product.

Timeline

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

Sep 2011Jul 2012

First posted6 Jul 2011 (estimated)
Study startSep 2011
Primary completionJul 2012
Study completionJul 2012

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: 413 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01388361
Sponsor's protocol ID: NN1250-3948
Other IDs: 2011-001493-25, U1111-1120-2782
Acronym: BEGIN™
Status last verified: Jan 2017
First submitted: 4 Jul 2011
Last updated: 6 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Mathieu C, Rodbard HW, Cariou B, Handelsman Y, Philis-Tsimikas A, Ocampo Francisco AM, Rana A, Zinman B; BEGIN: VICTOZA ADD-ON (NN1250-3948) study group. A comparison of adding liraglutide versus a single daily dose of insulin aspart to insulin degludec in subjects with type 2 diabetes (BEGIN: VICTOZA ADD-ON). Diabetes Obes Metab. 2014 Jul;16(7):636-44. doi: 10.1111/dom.12262. Epub 2014 Feb 11.
PubMed 24443830

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

Not yet recruitingPhase 3
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
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

All Diabetes trials

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 Adding Liraglutide Versus Addition of Insulin Aspart With the Largest Meal to Insulin Degludec, Both in Combination With Metformin, in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification (BEGIN™: VICTOZA® ADD-ON)
ClinicalTrials.gov ID: NCT01388361
Acronym / sponsor ID: BEGIN™ / NN1250-3948
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 413 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 6 Jul 2011 (estimated)
Results: Posted 26 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: 3

Arm	Type	Receives
IDeg (non-randomised)	Experimental	Drug: insulin degludec
IDeg + IAsp	Experimental	Drug: insulin degludec, Drug: insulin aspart
IDeg + liraglutide	Experimental	Drug: insulin degludec, Drug: liraglutide

Who may qualify

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

Key inclusion criteria (3 listed)

Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
The subject must have completed the end of treatment visit of NN1250-3643 with Insulin degludec once daily + metformin.
Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol

Key exclusion criteria (4 listed)

Participated in NN1250-3643 and treated with insulin glargine
Previous treatment with glucacon like peptide (GLP-1) receptor agonists (e.g. exenatide, liraglutide)
Impaired liver function, defined as alanine aminotransferase (ALAT) 2.5 times the upper limit of normal at end of treatment in NN1250-3643
Impaired renal function defined as serum-creatinine = 125 µmol/l (= 1.4 mg/dl) for males and = 110 µmol/L (= 1.3 mg/dl) for females or according to local label for metformin [For France: glomerular filtration rate below 60 ml/min, calculated by the Cockroft \& Gault formula] at end of treatment in NN1250-3643.

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 s.c. (under the skin) once daily. The doses will be individually adjusted	Drug	IDeg (non-randomised), IDeg + IAsp, IDeg + liraglutide
insulin aspartInjected s.c. (under the skin) once daily. The doses will be individually adjusted.	Drug	IDeg + IAsp
liraglutideInjected s.c. (under the skin) once daily. The doses will be individually adjusted.	Drug	IDeg + liraglutide

Primary outcome

Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)
Time frame: week 0, week 26
Values for change in HbA1c from baseline to 26 weeks of treatment period.

3 secondary outcomes

Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame: week 0, week 26
Change From Baseline in Body Weight
Time frame: week 0, week 26
Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
Time frame: Onset on or after the first day of exposure to investigational product for 26 weeks of treatment period and no later than 7 days after last exposure to investigational product.

Results and safety

Results posted to the registry on 26 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	236	224
IDeg + Liraglutide	88	76
IDeg + IAsp OD	89	75

Primary outcome: Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)

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

Measure	IDeg n = 236	IDeg + Liraglutide n = 88	IDeg + IAsp OD n = 89
Value	0.10 (0.40)	-0.74 (0.73)	-0.39 (0.72)

Population analysed: The FAS and NAS included all randomised and non-randomised subjects respectively, and missing data was imputed using last observation carried forward (LOCF).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment emergent adverse events were collected during 26 week treatment period + 7 days follow up.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IDeg	11 of 236 (4.7%)	64 of 236 (27.1%)	Not reported
IDeg + Liraglutide	4 of 87 (4.6%)	40 of 87 (46%)	Not reported
IDeg + IAsp OD	5 of 86 (5.8%)	18 of 86 (20.9%)	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 24443830Mathieu C, Rodbard HW, Cariou B, Handelsman Y, Philis-Tsimikas A, Ocampo Francisco AM, Rana A, Zinman B; BEGIN: VICTOZA ADD-ON (NN1250-3948) study group. A comparison of adding liraglutide versus a single daily dose of insulin aspart to insulin degludec in subjects with type 2 diabetes (BEGIN: VICTOZA ADD-ON). Diabetes Obes Metab. 2014 Jul;16(7):636-44. doi: 10.1111/dom.12262. Epub 2014 Feb 11.
Clinical Trials at Novo NordiskLink provided by the sponsor.

Related trials for Diabetes

Not yet recruitingPhase 3
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
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

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

124 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin degludec, insulin aspart and liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 124 sites in 12 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 3 inclusion and 4 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 124 sites in United States, Canada, Germany, Norway, Spain and 7 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 26 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 From Baseline in HbA1c (%) (Glycosylated Haemoglobin) (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 NCT01388361, 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.