DiabetesPhase 3DUAL™ IINCT01392573

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Subjects With Type 2 Diabetes

A Phase 3 study testing insulin degludec/liraglutide and insulin degludec in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 86 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 is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) and insulin degludec (IDeg) 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/liraglutide and insulin degludec
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 413 participants
Where: 86 sitesin 7 countries
Study dates: 28 Nov 2011to 4 Oct 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

Subjects with type 2 diabetes
HbA1c (glycosylated haemoglobin) 7.5-10.0% (both inclusive)
Subjects on stable daily doses for at least 90 days prior to trial start of: Basal insulin (total daily basal insulin dose within the range of 20-40U in combination with: metformin (1500 mg or more or max. tolerated dose) or metformin (1500 mg or more or max. tolerated dose) and SU (sulfonylurea) (equal to or more than half of the max. approved dose according to local label) or metformin and glinides (equal to or more than half of the max. approved dose according to local label)
BMI (Body Mass Index) more than or equal to 27 kg/m^2

Who cannot join

Treatment with glucagon like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide), dipeptidyl peptidase 4 (DPP-4) inhibitors and/or thiazolidinediones within 90 days prior to trial start
Impaired liver function
Impaired renal function
Screening calcitonin equal to or above 50 ng/l
Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 52 weeks prior to trial start and/or planned coronary, carotid or peripheral artery revascularisation procedures

Show all 9Show fewer

Severe uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mm Hg or diastolic blood pressure equal to or above 100 mm Hg)
Acute treatment required proliferative retinopathy or maculopathy (macular oedema) according to physician's opinion
History of chronic pancreatitis or idiopathic acute pancreatitis

Trial locations and contacts

86 sites in 7 countries.

Country

City, postcode or hospital

86 sites in 7 countries

United States58 sites

Novo Nordisk Investigational Site
Albany, New York, 12206
Novo Nordisk Investigational Site
Anaheim, California, 92801
Novo Nordisk Investigational Site
Arlington, Texas, 76014
Novo Nordisk Investigational Site
Arlington Heights, Illinois, 60004-2315
Novo Nordisk Investigational Site
Asheboro, North Carolina, 27203
Novo Nordisk Investigational Site
Austin, Texas, 78731
Novo Nordisk Investigational Site
Avon, Illinois, 46123
Novo Nordisk Investigational Site
Beaver, Pennsylvania, 15009
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, 27517
Novo Nordisk Investigational Site
Chesterfield, Missouri, 63017
Novo Nordisk Investigational Site
Chicago, Illinois, 60607
Novo Nordisk Investigational Site
Colorado Springs, Colorado, 80910
Novo Nordisk Investigational Site
Crystal Lake, Illinois, 60012
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75246
Novo Nordisk Investigational Site
Dallas, Texas, 75251
Novo Nordisk Investigational Site
Greenfield, Indiana, 46140
Novo Nordisk Investigational Site
Greensboro, North Carolina, 27408
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
Novo Nordisk Investigational Site
Gurnee, Illinois, 60031
Novo Nordisk Investigational Site
Hickory, North Carolina, 28602
Novo Nordisk Investigational Site
Huntsville, Alabama, 35801
Novo Nordisk Investigational Site
Hurst, Texas, 76054
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46254
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, 08648
Novo Nordisk Investigational Site
Lexington, Kentucky, 40503
Novo Nordisk Investigational Site
Los Angeles, California, 90057
Novo Nordisk Investigational Site
Melbourne, Florida, 32934
Novo Nordisk Investigational Site
Metairie, Louisiana, 70002
Novo Nordisk Investigational Site
Metairie, Louisiana, 70006-2930
Novo Nordisk Investigational Site
Methuen, Massachusetts, 01844
Novo Nordisk Investigational Site
Miami, Florida, 33156
Novo Nordisk Investigational Site
Muncie, Indiana, 47304
Novo Nordisk Investigational Site
Nashua, New Hampshire, 03063
Novo Nordisk Investigational Site
Nashville, Tennessee, 37203
Novo Nordisk Investigational Site
New Albany, Indiana, 47150
Novo Nordisk Investigational Site
North Dartmouth, Massachusetts, 02747
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19152
Novo Nordisk Investigational Site
Rockville, Maryland, 20852
Novo Nordisk Investigational Site
Roswell, Georgia, 30076
Novo Nordisk Investigational Site
Saint Charles, Missouri, 63303
Novo Nordisk Investigational Site
Salt Lake City, Utah, 84107
Novo Nordisk Investigational Site
San Antonio, Texas, 78215
Novo Nordisk Investigational Site
San Antonio, Texas, 78224
Novo Nordisk Investigational Site
San Antonio, Texas, 78229
Novo Nordisk Investigational Site
Simpsonville, South Carolina, 29681
Novo Nordisk Investigational Site
Slidell, Louisiana, 70461-4231
Novo Nordisk Investigational Site
Smithtown, New York, 11787
Novo Nordisk Investigational Site
Southfield, Michigan, 48034-7661
Novo Nordisk Investigational Site
Statesville, North Carolina, 28625
Novo Nordisk Investigational Site
Sugar Land, Texas, 77478
Novo Nordisk Investigational Site
Toms River, New Jersey, 08755-8050
Novo Nordisk Investigational Site
Tustin, California, 92780
Novo Nordisk Investigational Site
Ventura, California, 93003
Novo Nordisk Investigational Site
Vestavia Hills, Alabama, 35209
Novo Nordisk Investigational Site
Waltham, Massachusetts, 02453
Novo Nordisk Investigational Site
Waterbury, Connecticut, 06708

Other trials in United States

Bulgaria6 sites

Novo Nordisk Investigational Site
Burgas, 8000
Novo Nordisk Investigational Site
Haskovo, 6300
Novo Nordisk Investigational Site
Lukovit, 5770
Novo Nordisk Investigational Site
Plovdiv, 4001
Novo Nordisk Investigational Site
Rousse, 7000
Novo Nordisk Investigational Site
Sofia, 1712

Other trials in Bulgaria

India6 sites

Novo Nordisk Investigational Site
Chennai, Tamil Nadu, 600086
Novo Nordisk Investigational Site
Dhantoli, Nagpur, 440012
Novo Nordisk Investigational Site
Kolkata, West Bengal, 700064
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400008
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400053
Novo Nordisk Investigational Site
Pune, Maharashtra, 411001.

Other trials in India

Switzerland6 sites

Novo Nordisk Investigational Site
Basel, 4031
Novo Nordisk Investigational Site
Bern, 3010
Novo Nordisk Investigational Site
Interlaken-Unterseen, 3800
Novo Nordisk Investigational Site
Lausanne, 1011
Novo Nordisk Investigational Site
Lucerne, 6000
Novo Nordisk Investigational Site
Sankt Gallen, 9007

Other trials in Switzerland

Hungary4 sites

Novo Nordisk Investigational Site
Budapest, 1125
Novo Nordisk Investigational Site
Debrecen, 4043
Novo Nordisk Investigational Site
Eger, H-3300
Novo Nordisk Investigational Site
Szombathely, H-9700

Other trials in Hungary

Denmark3 sites

Novo Nordisk Investigational Site
Århus C, 8000
Novo Nordisk Investigational Site
Gentofte Municipality, 2820
Novo Nordisk Investigational Site
Hellerup, 2900

Other trials in Denmark

Slovenia3 sites

Novo Nordisk Investigational Site
Koper, SI-6000
Novo Nordisk Investigational Site
Ljubljana, 1525
Novo Nordisk Investigational Site
Novo Mesto, 8000

Other trials in Slovenia

About this study

Official title: A 26-week Randomised, Parallel Two-arm, Double-blind, Multi-centre, Multinational, Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide With Insulin Degludec in Subjects With Type 2 Diabetes

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin degludec/liraglutide, 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 degludec/liraglutideDrug
IDeg/Lira treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDegLira is injected subcutaneously (under the skin) once daily.
insulin degludecDrug
IDeg treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDeg is injected subcutaneously (under the skin) once daily.

Study groups in NCT01392573
Study group	Role	What they receive
IDegLira + metformin	Experimental	IDegLira was injected subcutaneously once daily for 26 weeks. Receives: Drug: insulin degludec/liraglutide
IDeg + metformin	Experimental	IDeg was injected subcutaneously once daily for 26 weeks. Receives: Drug: insulin degludec

What is being measured

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

Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Observed mean change from baseline in HbA1c after 26 Weeks of treatment.
Measured: Week 0, week 26

Secondary outcomes (1)

Change in Body Weight
Observed mean 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.

28 Nov 20114 Oct 2012

First posted12 Jul 2011 (estimated)
Study start28 Nov 2011
Primary completion1 Oct 2012
Study completion4 Oct 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 (7)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: Double blind
Who is masked: Participant, Investigator
Enrolment: 413 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01392573
Sponsor's protocol ID: NN9068-3912
Other IDs: 2011-002336-72, U1111-1121-4897
Acronym: DUAL™ II
Status last verified: Dec 2018
First submitted: 7 Jul 2011
Last updated: 3 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Khunti K, Mohan V, Jain SM, Boesgaard TW, Begtrup K, Sethi B. Efficacy and Safety of IDegLira in Participants with Type 2 Diabetes in India Uncontrolled on Oral Antidiabetic Drugs and Basal Insulin: Data from the DUAL Clinical Trial Program. Diabetes Ther. 2017 Jun;8(3):673-682. doi: 10.1007/s13300-017-0252-9. Epub 2017 Mar 22.
PubMed 28332144
Ericsson A, Lundqvist A. Cost Effectiveness of Insulin Degludec Plus Liraglutide (IDegLira) in a Fixed Combination for Uncontrolled Type 2 Diabetes Mellitus in Sweden. Appl Health Econ Health Policy. 2017 Apr;15(2):237-248. doi: 10.1007/s40258-016-0301-y.
PubMed 28063135
Buse JB, Vilsboll T, Thurman J, Blevins TC, Langbakke IH, Bottcher SG, Rodbard HW; NN9068-3912 (DUAL-II) Trial Investigators. Contribution of liraglutide in the fixed-ratio combination of insulin degludec and liraglutide (IDegLira). Diabetes Care. 2014 Nov;37(11):2926-33. doi: 10.2337/dc14-0785. Epub 2014 Aug 11.
PubMed 25114296
Vilsboll T, Vora J, Jarlov H, Kvist K, Blonde L. Type 2 Diabetes Patients Reach Target Glycemic Control Faster Using IDegLira than Either Insulin Degludec or Liraglutide Given Alone. Clin Drug Investig. 2016 Apr;36(4):293-303. doi: 10.1007/s40261-016-0376-0.
PubMed 26894800
King AB, Philis-Tsimikas A, Kilpatrick ES, Langbakke IH, Begtrup K, Vilsboll T. A Fixed Ratio Combination of Insulin Degludec and Liraglutide (IDegLira) Reduces Glycemic Fluctuation and Brings More Patients with Type 2 Diabetes Within Blood Glucose Target Ranges. Diabetes Technol Ther. 2017 Apr;19(4):255-264. doi: 10.1089/dia.2016.0405. Epub 2017 Mar 10.
PubMed 28282219
Lingvay I, Handelsman Y, Linjawi S, Vilsboll T, Halladin N, Ranc K, Liebl A. EFFICACY AND SAFETY OF IDEGLIRA IN OLDER PATIENTS WITH TYPE 2 DIABETES. Endocr Pract. 2019 Feb;25(2):144-155. doi: 10.4158/EP-2018-0284. Epub 2018 Nov 1.
PubMed 30383495
Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
PubMed 39963952

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 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 26-week Randomised, Parallel Two-arm, Double-blind, Multi-centre, Multinational, Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide With Insulin Degludec in Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT01392573
Acronym / sponsor ID: DUAL™ II / NN9068-3912
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: 28 Nov 2011 (actual)
Primary completion: 1 Oct 2012 (actual)
Study completion: 4 Oct 2012 (actual)
First posted: 12 Jul 2011 (estimated)
Results: Posted 20 Jan 2017

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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
IDegLira + metformin	Experimental	Drug: insulin degludec/liraglutideIDegLira was injected subcutaneously once daily for 26 weeks.
IDeg + metformin	Experimental	Drug: insulin degludecIDeg was injected subcutaneously once daily for 26 weeks.

Who may qualify

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

Key inclusion criteria (4 listed)

Subjects with type 2 diabetes
HbA1c (glycosylated haemoglobin) 7.5-10.0% (both inclusive)
Subjects on stable daily doses for at least 90 days prior to trial start of: Basal insulin (total daily basal insulin dose within the range of 20-40U in combination with: metformin (1500 mg or more or max. tolerated dose) or metformin (1500 mg or more or max. tolerated dose) and SU (sulfonylurea) (equal to or more than half of the max. approved dose according to local label) or metformin and glinides (equal to or more than half of the max. approved dose according to local label)
BMI (Body Mass Index) more than or equal to 27 kg/m^2

Key exclusion criteria (9 listed)

Treatment with glucagon like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide), dipeptidyl peptidase 4 (DPP-4) inhibitors and/or thiazolidinediones within 90 days prior to trial start
Impaired liver function
Impaired renal function
Screening calcitonin equal to or above 50 ng/l
Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)

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 degludec/liraglutideIDeg/Lira treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDegLira is injected subcutaneously (under the skin) once daily.	Drug	IDegLira + metformin
insulin degludecIDeg treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDeg is injected subcutaneously (under the skin) once daily.	Drug	IDeg + metformin

Primary outcome

Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Time frame: Week 0, week 26
Observed mean 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 20 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IDegLira	207	175
IDeg	206	171

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

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

Measure	IDegLira n = 199	IDeg n = 199
Value	-1.90 (1.09)	-0.89 (1.18)

IDegLira vs IDeg: Treatment contrast: -1.05 (95% CI -1.25 to -0.84), p <0.0001, ANCOVA

Population analysed: Full analysis set. Missing data was imputed using last observation carried forward (LOCF).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IDegLira	7 of 199 (3.5%)	45 of 199 (22.6%)	Not reported
IDeg	11 of 199 (5.5%)	29 of 199 (14.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28332144Khunti K, Mohan V, Jain SM, Boesgaard TW, Begtrup K, Sethi B. Efficacy and Safety of IDegLira in Participants with Type 2 Diabetes in India Uncontrolled on Oral Antidiabetic Drugs and Basal Insulin: Data from the DUAL Clinical Trial Program. Diabetes Ther. 2017 Jun;8(3):673-682. doi: 10.1007/s13300-017-0252-9. Epub 2017 Mar 22.
Background: PubMed 28063135Ericsson A, Lundqvist A. Cost Effectiveness of Insulin Degludec Plus Liraglutide (IDegLira) in a Fixed Combination for Uncontrolled Type 2 Diabetes Mellitus in Sweden. Appl Health Econ Health Policy. 2017 Apr;15(2):237-248. doi: 10.1007/s40258-016-0301-y.
Results publication: PubMed 25114296Buse JB, Vilsboll T, Thurman J, Blevins TC, Langbakke IH, Bottcher SG, Rodbard HW; NN9068-3912 (DUAL-II) Trial Investigators. Contribution of liraglutide in the fixed-ratio combination of insulin degludec and liraglutide (IDegLira). Diabetes Care. 2014 Nov;37(11):2926-33. doi: 10.2337/dc14-0785. Epub 2014 Aug 11.
Results publication: PubMed 26894800Vilsboll T, Vora J, Jarlov H, Kvist K, Blonde L. Type 2 Diabetes Patients Reach Target Glycemic Control Faster Using IDegLira than Either Insulin Degludec or Liraglutide Given Alone. Clin Drug Investig. 2016 Apr;36(4):293-303. doi: 10.1007/s40261-016-0376-0.
Results publication: PubMed 28282219King AB, Philis-Tsimikas A, Kilpatrick ES, Langbakke IH, Begtrup K, Vilsboll T. A Fixed Ratio Combination of Insulin Degludec and Liraglutide (IDegLira) Reduces Glycemic Fluctuation and Brings More Patients with Type 2 Diabetes Within Blood Glucose Target Ranges. Diabetes Technol Ther. 2017 Apr;19(4):255-264. doi: 10.1089/dia.2016.0405. Epub 2017 Mar 10.
Results publication: PubMed 30383495Lingvay I, Handelsman Y, Linjawi S, Vilsboll T, Halladin N, Ranc K, Liebl A. EFFICACY AND SAFETY OF IDEGLIRA IN OLDER PATIENTS WITH TYPE 2 DIABETES. Endocr Pract. 2019 Feb;25(2):144-155. doi: 10.4158/EP-2018-0284. Epub 2018 Nov 1.
Derived from this study: PubMed 39963952Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
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

86 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/liraglutide and insulin degludec in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 86 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 9 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 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Bulgaria, India, Switzerland, 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 20 Jan 2017). 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 NCT01392573, which also lists 7 linked publications.

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 Jan 2019.