DiabetesPhase 3BEGIN™NCT01076647

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 105 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 Europe and North America. The aim of this clinical trial was to compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or DPP-4 (dipeptyl peptidase 4) inhibitors, in… 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: 467 participants
Where: 105 sitesin 7 countries
Study dates: Mar 2010to Dec 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
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 insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) 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 daily or maximum tolerated dose (at least 1000 mg daily)-Insulin secretagogue (sulfonylurea (SU) 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
BMI (Body Mass Index) below or equal to 45.0 kg/m^2

Who cannot join

Use within the last 3 months prior to Visit 1 of: Thiazoledinediones (TZDs), 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
Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)

Trial locations and contacts

105 sites in 7 countries.

Country

City, postcode or hospital

105 sites in 7 countries

United States66 sites

Novo Nordisk Investigational Site
Altoona, Pennsylvania, 16601
Novo Nordisk Investigational Site
Altoona, Pennsylvania, 16602
Novo Nordisk Investigational Site
Ann Arbor, Michigan, 48106-0482
Novo Nordisk Investigational Site
Arlington, Texas, 76014
Novo Nordisk Investigational Site
Arlington Heights, Illinois, 60004-2315
Novo Nordisk Investigational Site
Asheville, North Carolina, 28801
Novo Nordisk Investigational Site
Beverly Hills, California, 90211
Novo Nordisk Investigational Site
Birmingham, Alabama, 35216
Novo Nordisk Investigational Site
Boynton Beach, Florida, 33472
Novo Nordisk Investigational Site
Burlington, North Carolina, 27215-8700
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37404
Novo Nordisk Investigational Site
Chesapeake, Virginia, 23320
Novo Nordisk Investigational Site
Chicago, Illinois, 60607
Novo Nordisk Investigational Site
Chicago, Illinois, 60622
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45255
Novo Nordisk Investigational Site
Conyers, Georgia, 30094-5965
Novo Nordisk Investigational Site
Crestview Hills, Kentucky, 41017-3464
Novo Nordisk Investigational Site
Dallas, Texas, 75251
Novo Nordisk Investigational Site
Dayton, Ohio, 45406
Novo Nordisk Investigational Site
DeLand, Florida, 32720
Novo Nordisk Investigational Site
Denver, Colorado, 80209
Novo Nordisk Investigational Site
Dunwoody, Georgia, 30338
Novo Nordisk Investigational Site
Eagan, Minnesota, 55123
Novo Nordisk Investigational Site
East Providence, Rhode Island, 02914
Novo Nordisk Investigational Site
Escondido, California, 92025
Novo Nordisk Investigational Site
Glen Burnie, Maryland, 21061
Novo Nordisk Investigational Site
Golden, Colorado, 80401
Novo Nordisk Investigational Site
Harrisburg, Pennsylvania, 17112-1900
Novo Nordisk Investigational Site
Houston, Texas, 77025
Novo Nordisk Investigational Site
Kingsport, Tennessee, 37660
Novo Nordisk Investigational Site
Kissimmee, Florida, 34741
Novo Nordisk Investigational Site
La Jolla, California, 92037
Novo Nordisk Investigational Site
Langhorne, Pennsylvania, 19047
Novo Nordisk Investigational Site
Los Angeles, California, 90057
Novo Nordisk Investigational Site
Los Banos, California, 93635
Novo Nordisk Investigational Site
Madisonville, Kentucky, 42431
Novo Nordisk Investigational Site
Metairie, Louisiana, 70002
Novo Nordisk Investigational Site
Miami, Florida, 33156
Novo Nordisk Investigational Site
Monterey, California, 93940
Novo Nordisk Investigational Site
Newberry, South Carolina, 29108-2249
Novo Nordisk Investigational Site
Ogden, Utah, 84403
Novo Nordisk Investigational Site
Orange Park, Florida, 32073
Novo Nordisk Investigational Site
Palm Springs, California, 92262
Novo Nordisk Investigational Site
Pasadena, California, 91105
Novo Nordisk Investigational Site
Peoria, Arizona, 85381
Novo Nordisk Investigational Site
Plantation, Florida, 33324
Novo Nordisk Investigational Site
Redondo Beach, California, 90277
Novo Nordisk Investigational Site
Reisterstown, Maryland, 21136-2516
Novo Nordisk Investigational Site
Round Rock, Texas, 78681
Novo Nordisk Investigational Site
Salt Lake City, Utah, 84102
Novo Nordisk Investigational Site
Salt Lake City, Utah, 84107
Novo Nordisk Investigational Site
San Mateo, California, 94401
Novo Nordisk Investigational Site
Seattle, Washington, 98105
Novo Nordisk Investigational Site
Silver Spring, Maryland, 20910
Novo Nordisk Investigational Site
Smithtown, New York, 11787
Novo Nordisk Investigational Site
Spokane, Washington, 99218
Novo Nordisk Investigational Site
Springfield, Illinois, 62711
Novo Nordisk Investigational Site
Staten Island, New York, 10301
Novo Nordisk Investigational Site
Tampa, Florida, 33613
Novo Nordisk Investigational Site
Tarzana, California, 91356-3551
Novo Nordisk Investigational Site
Tucson, Arizona, 85712
Novo Nordisk Investigational Site
Tustin, California, 92780
Novo Nordisk Investigational Site
West Palm Beach, Florida, 33401
Novo Nordisk Investigational Site
Whiteville, North Carolina, 28472
Novo Nordisk Investigational Site
Wichita, Kansas, 67205
Novo Nordisk Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

France8 sites

Novo Nordisk Investigational Site
La Roche-sur-Yon, 85295
Novo Nordisk Investigational Site
La Rochelle, 17019
Novo Nordisk Investigational Site
Le Creusot, 71200
Novo Nordisk Investigational Site
Nanterre, 92014
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Nîmes, 30006
Novo Nordisk Investigational Site
Paris, 75877
Novo Nordisk Investigational Site
Vénissieux, 69200

Other trials in France

Netherlands8 sites

Novo Nordisk Investigational Site
Amsterdam, 1105 AZ
Novo Nordisk Investigational Site
Beek, 6191JW
Novo Nordisk Investigational Site
Etten-Leur, 4872 LP
Novo Nordisk Investigational Site
Hengelo, 7555 DL
Novo Nordisk Investigational Site
Hoogeveen, 7909 AA
Novo Nordisk Investigational Site
Lieshout, 5737 CB
Novo Nordisk Investigational Site
Utrecht, 3582 KE
Novo Nordisk Investigational Site
Zwijndrecht, 3331 LZ

Other trials in Netherlands

Canada7 sites

Novo Nordisk Investigational Site
Chilliwack, British Columbia, V2P 4M9
Novo Nordisk Investigational Site
Ottawa, Ontario, K1K 4L2
Novo Nordisk Investigational Site
Québec, Quebec, G1N 4V3
Novo Nordisk Investigational Site
Québec, Quebec, G1V 4G5
Novo Nordisk Investigational Site
Québec, Quebec, G3K 2P8
Novo Nordisk Investigational Site
Thornhill, Ontario, L4J 8L7
Novo Nordisk Investigational Site
Toronto, Ontario, M5C 2T2

Other trials in Canada

Hungary6 sites

Novo Nordisk Investigational Site
Budapest, 1125
Novo Nordisk Investigational Site
Debrecen, 4043
Novo Nordisk Investigational Site
Eger, 3300
Novo Nordisk Investigational Site
Gyula, 5700
Novo Nordisk Investigational Site
Kaposvár, H-7400
Novo Nordisk Investigational Site
Szeged, H-6720

Other trials in Hungary

Romania6 sites

Novo Nordisk Investigational Site
Bacau, 600164
Novo Nordisk Investigational Site
Botoșani, 710224
Novo Nordisk Investigational Site
Bucharest, 010816
Novo Nordisk Investigational Site
Galati, 800578
Novo Nordisk Investigational Site
Oradea, Bihor County, 410469
Novo Nordisk Investigational Site
Satu Mare, Satu Mare County, 440055

Other trials in Romania

Bulgaria4 sites

Novo Nordisk Investigational Site
Burgas, 8000
Novo Nordisk Investigational Site
Rousse, 7000
Novo Nordisk Investigational Site
Sofia, 1606
Novo Nordisk Investigational Site
Stara Zagora, 6000

Other trials in Bulgaria

About this study

Official title: A 26-week Randomised, Confirmatory, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA 200 U/ml Three Times Weekly Injected in the Evening and Insulin Glargine Once Daily in a Population of Insulin naïve Subjects With Type 2 Diabetes Mellitus Currently Treated With OADs Qualifying for Intensified Treatment (BEGIN™: EASY™)

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
Will be injected subcutaneously (under the skin) once daily three times weekly.
insulin glargineDrug
Will be injected subcutaneously (under the skin) once daily administered at the same time each day.

Study groups in NCT01076647
Study group	Role	What they receive
IDeg 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 26 weeks of treatment
Measured: Week 0, Week 26

Secondary outcomes (1)

Change in Body Weight
Change from baseline in body weight 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.

Mar 2010Dec 2010

First posted26 Feb 2010 (estimated)
Study startMar 2010
Primary completionDec 2010
Study completionDec 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: 467 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01076647
Sponsor's protocol ID: NN1250-3718
Other IDs: 2009-011399-31, U1111-1112-8770, 2009
Acronym: BEGIN™
Status last verified: Jan 2017
First submitted: 25 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

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 26-week Randomised, Confirmatory, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA 200 U/ml Three Times Weekly Injected in the Evening and Insulin Glargine Once Daily in a Population of Insulin naïve Subjects With Type 2 Diabetes Mellitus Currently Treated With OADs Qualifying for Intensified Treatment (BEGIN™: EASY™)
ClinicalTrials.gov ID: NCT01076647
Acronym / sponsor ID: BEGIN™ / NN1250-3718
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 467 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 26 Feb 2010 (estimated)
Results: Posted 10 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 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 (5 listed)

Type 2 diabetes (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 insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) 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 daily or maximum tolerated dose (at least 1000 mg daily)-Insulin secretagogue (sulfonylurea (SU) 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
BMI (Body Mass Index) 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 (TZDs), 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
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 degludecWill be injected subcutaneously (under the skin) once daily three times weekly.	Drug	IDeg 3TW
insulin glargineWill be injected subcutaneously (under the skin) once daily administered at the same time each day.	Drug	IGlar OD

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 Body Weight
Time frame: Week 0, Week 26

Results and safety

Results posted to the registry on 10 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 3TW	233	208
IGlar OD	234	209

Primary outcome: Change in Glycosylated Haemoglobin (HbA1c)

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

Measure	IDeg 3TW n = 233	IGlar OD n = 234
Value	-1.05 (0.94)	-1.36 (0.95)

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

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 3TW	13 of 233 (5.6%)	34 of 233 (14.6%)	Not reported
IGlar OD	12 of 234 (5.1%)	25 of 234 (10.7%)	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.

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

105 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 insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 105 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 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 105 sites in United States, France, Netherlands, Canada, Hungary 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 10 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 NCT01076647, 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.