DiabetesPhase 3NCT02420262

A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus

A Phase 3 study testing insulin degludec/liraglutide, insulin glargine and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 117 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 globally. The aim of this trial is to compare efficacy and safety of insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in combination with metformin in subjects with type 2 diabetes mellitus. 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, insulin glargine and insulin aspart
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 506 participants
Where: 117 sitesin 12 countries
Study dates: 26 Jul 2015to 5 Oct 2016
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

Male or female, age at least 18 years at the time of signing informed consent
Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
HbA1c (glycosylated haemoglobin) 7.0-10.0% [53mmol/mol-86mmol/mol] (both inclusive) by central laboratory analysis
Current treatment with IGlar (insulin glargine) for at least 90 calendar days prior to screening
Stable daily dose of IGlar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. Individual fluctuations of plus/minus 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive
Stable daily dose of metformin (at least 1500 mg or max tolerated dose) for at least 90 calendar days prior to screening
Body mass index (BMI) below or equal to 40 kg/m^2

Who cannot join

Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening
Anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)
Impaired liver function, defined as alanine aminotransferase (ALT) at least 2.5 times upper limit of normal
Renal impairment eGFR (electronic case report form) below 60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
Screening calcitonin at least 50 ng/L
History of pancreatitis (acute or chronic)
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2

Trial locations and contacts

117 sites in 12 countries.

Country

City, postcode or hospital

117 sites in 12 countries

United States50 sites

Novo Nordisk Investigational Site
Albany, New York, 12206
Novo Nordisk Investigational Site
Albuquerque, New Mexico, 87102
Novo Nordisk Investigational Site
Altoona, Pennsylvania, 16602
Novo Nordisk Investigational Site
Anaheim, California, 92801
Novo Nordisk Investigational Site
Bermuda Dunes, California, 92203
Novo Nordisk Investigational Site
Billings, Montana, 59101
Novo Nordisk Investigational Site
Blackfoot, Idaho, 83221
Novo Nordisk Investigational Site
Chicago, Illinois, 60607
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45245
Novo Nordisk Investigational Site
Columbus, Ohio, 43213
Novo Nordisk Investigational Site
Dayton, Ohio, 45439
Novo Nordisk Investigational Site
Fresno, California, 93720
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
Novo Nordisk Investigational Site
Houston, Texas, 77024
Novo Nordisk Investigational Site
Houston, Texas, 77058
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46254
Novo Nordisk Investigational Site
Jackson Heights, New York, 11372
Novo Nordisk Investigational Site
Kingsport, Tennessee, 37660
Novo Nordisk Investigational Site
Lancaster, California, 93534
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89109
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89128
Novo Nordisk Investigational Site
Lincoln, California, 95648
Novo Nordisk Investigational Site
Lomita, California, 90717
Novo Nordisk Investigational Site
Los Angeles, California, 90057
Novo Nordisk Investigational Site
Mason, Ohio, 45040-6815
Novo Nordisk Investigational Site
Metairie, Louisiana, 70002
Novo Nordisk Investigational Site
Midlothian, Virginia, 23114
Novo Nordisk Investigational Site
Montclair, California, 91763
Novo Nordisk Investigational Site
Murrells Inlet, South Carolina, 29576
Novo Nordisk Investigational Site
Natchitoches, Louisiana, 71457-5881
Novo Nordisk Investigational Site
New Windsor, New York, 12553
Novo Nordisk Investigational Site
Northridge, California, 91325
Novo Nordisk Investigational Site
Palm Harbor, Florida, 34684-3609
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19152
Novo Nordisk Investigational Site
Plantation, Florida, 33324
Novo Nordisk Investigational Site
Rockville, Maryland, 20852
Novo Nordisk Investigational Site
San Antonio, Texas, 78229
Novo Nordisk Investigational Site
San Mateo, California, 94401
Novo Nordisk Investigational Site
Shelby, North Carolina, 28150
Novo Nordisk Investigational Site
Shreveport, Louisiana, 71105
Novo Nordisk Investigational Site
Skokie, Illinois, 60077
Novo Nordisk Investigational Site
Spokane, Washington, 99208
Novo Nordisk Investigational Site
Statesville, North Carolina, 28625
Novo Nordisk Investigational Site
Sugar Land, Texas, 77478
Novo Nordisk Investigational Site
Sugar Land, Texas, 77479
Novo Nordisk Investigational Site
Tuscumbia, Alabama, 35674
Novo Nordisk Investigational Site
Ventura, California, 93003
Novo Nordisk Investigational Site
Waltham, Massachusetts, 02453
Novo Nordisk Investigational Site
Waterbury, Connecticut, 06708
Novo Nordisk Investigational Site
West Seneca, New York, 14224

Other trials in United States

France12 sites

Novo Nordisk Investigational Site
Angers, 49000
Novo Nordisk Investigational Site
Bourgoin, 38302
Novo Nordisk Investigational Site
Brest, 29609
Novo Nordisk Investigational Site
La Rochelle, 17019
Novo Nordisk Investigational Site
Le Coudray, 28630
Novo Nordisk Investigational Site
Le Creusot, 71200
Novo Nordisk Investigational Site
Marseille, 13008
Novo Nordisk Investigational Site
Marseille, 13285
Novo Nordisk Investigational Site
Saint-Herblain, 44800
Novo Nordisk Investigational Site
Saint-Priest-en-Jarez, 42270
Novo Nordisk Investigational Site
Strasbourg, 67098
Novo Nordisk Investigational Site
Vénissieux, 69200

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Russia7 sites

Novo Nordisk Investigational Site
Kazan', 420073
Novo Nordisk Investigational Site
Moscow, 117036
Novo Nordisk Investigational Site
Saint Petersburg, 191119
Novo Nordisk Investigational Site
Saint Petersburg, 194291
Novo Nordisk Investigational Site
Saint Petersburg, 194354
Novo Nordisk Investigational Site
Saint Petersburg, 199034
Novo Nordisk Investigational Site
Volgograd, 400131

Other trials in Russia

Czechia6 sites

Novo Nordisk Investigational Site
Brno, 65691
Novo Nordisk Investigational Site
Hradec Králové, 500 36
Novo Nordisk Investigational Site
Olomouc, 77900
Novo Nordisk Investigational Site
Olomouc, Lazce, 77900
Novo Nordisk Investigational Site
Pardubice, 53002
Novo Nordisk Investigational Site
Prostějov, 79601

Other trials in Czechia

Greece6 sites

Novo Nordisk Investigational Site
Athens, GR-11527
Novo Nordisk Investigational Site
Chalkida, Evia, GR-34100
Novo Nordisk Investigational Site
Ioannina, 45500
Novo Nordisk Investigational Site
Larissa, GR-41110
Novo Nordisk Investigational Site
Thessaloniki, GR-54642
Novo Nordisk Investigational Site
Thessaloniki, GR-57001

Other trials in Greece

Israel6 sites

Novo Nordisk Investigational Site
Haifa, 35152
Novo Nordisk Investigational Site
Holon, 58100
Novo Nordisk Investigational Site
Jerusalem, 91120
Novo Nordisk Investigational Site
Kfar Saba, 44281
Novo Nordisk Investigational Site
Nahariya, 22100
Novo Nordisk Investigational Site
Rehovot, 76100

Other trials in Israel

Spain6 sites

Novo Nordisk Investigational Site
Almería, 04001
Novo Nordisk Investigational Site
Fuenlabrada - Madrid, 28942
Novo Nordisk Investigational Site
Pozuelo de Alarcón, 28223
Novo Nordisk Investigational Site
Seville, 41003
Novo Nordisk Investigational Site
Seville, 41010
Novo Nordisk Investigational Site
Valencia, 46026

Other trials in Spain

Turkey (Türkiye)6 sites

Novo Nordisk Investigational Site
Ankara, 06100
Novo Nordisk Investigational Site
Ankara, 06110
Novo Nordisk Investigational Site
Antalya, 07058
Novo Nordisk Investigational Site
Istanbul, 34096
Novo Nordisk Investigational Site
Istanbul, 34303
Novo Nordisk Investigational Site
Istanbul, 34371

Other trials in Turkey (Türkiye)

Hungary5 sites

Novo Nordisk Investigational Site
Budapest, 1115
Novo Nordisk Investigational Site
Gyula, H-5700
Novo Nordisk Investigational Site
Szeged, H-6720
Novo Nordisk Investigational Site
Szombathely, H-9700
Novo Nordisk Investigational Site
Tatabánya, 2800

Other trials in Hungary

Slovakia5 sites

Novo Nordisk Investigational Site
Bardejov, 08501
Novo Nordisk Investigational Site
Dolný Kubín, 02601
Novo Nordisk Investigational Site
Malacky, 90101
Novo Nordisk Investigational Site
Poprad, 05801
Novo Nordisk Investigational Site
Rožňava, 04801

Other trials in Slovakia

Argentina4 sites

Novo Nordisk Investigational Site
CABA, C1440AAD
Novo Nordisk Investigational Site
Capital Federal, 1405
Novo Nordisk Investigational Site
Córdoba, X5006IKK
Novo Nordisk Investigational Site
Salta, 4400

Other trials in Argentina

Mexico4 sites

Novo Nordisk Investigational Site
Aguascalientes, 20230
Novo Nordisk Investigational Site
Durango, 34000
Novo Nordisk Investigational Site
Guadalajara, Jalisco, 44650
Novo Nordisk Investigational Site
Mexico City, México, D.F., 03300

Other trials in Mexico

About this study

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin degludec/liraglutide, insulin glargine, insulin aspart
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
Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.
insulin glargineDrug
Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.
insulin aspartDrug
Injected s.c./subcutaneously (under the skin) before each main meal.

Study groups in NCT02420262
Study group	Role	What they receive
IDegLira	Experimental	Not described Receives: Drug: insulin degludec/liraglutide
IGlar plus IAsp	Active comparator	Not described Receives: Drug: insulin glargine; Drug: insulin aspart

What is being measured

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

Change in HbA1c (Glycosylated Haemoglobin)
Change in HbA1c values after 26 weeks of treatment.
Measured: Week 0, Week 26

Secondary outcomes (4)

Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes.
Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia.
Measured: Weeks 0-26
Change in Body Weight
Change in body weight after 26 weeks of treatment.
Measured: Week 0, Week 26
Responder for HbA1c Below 7.0%
Number of subjects with HbA1c below 7% after 26 weeks of treatment.
Measured: After 26 weeks of treatment
Responder for HbA1c Below or Equal to 6.5 %
Number of subjects with HbA1c below 6.5% after 26 weeks of treatment.
Measured: After 26 weeks of treatment

Timeline

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

26 Jul 20155 Oct 2016

First posted17 Apr 2015 (estimated)
Study start26 Jul 2015
Primary completion5 Oct 2016
Study completion5 Oct 2016

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 (3)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: 506 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02420262
Sponsor's protocol ID: NN9068-4185
Other IDs: 2014-003621-18, U1111-1160-6923, REec-2015-1682, 2014
Status last verified: Feb 2018
First submitted: 8 Apr 2015
Last updated: 29 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Billings LK, Doshi A, Gouet D, Oviedo A, Rodbard HW, Tentolouris N, Gron R, Halladin N, Jodar E. Efficacy and Safety of IDegLira Versus Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes Uncontrolled on Metformin and Basal Insulin: The DUAL VII Randomized Clinical Trial. Diabetes Care. 2018 May;41(5):1009-1016. doi: 10.2337/dc17-1114. Epub 2018 Feb 26.
PubMed 29483185
Billings LK, Agner BFR, Altuntas Y, Gron R, Halladin N, Klonoff DC, Tentolouris N, Jodar E. The Benefit of Insulin Degludec/Liraglutide (IDegLira) Compared With Basal-Bolus Insulin Therapy is Consistent Across Participant Subgroups With Type 2 Diabetes in the DUAL VII Randomized Trial. J Diabetes Sci Technol. 2021 May;15(3):636-645. doi: 10.1177/1932296820906888. Epub 2020 Feb 28.
PubMed 32107930
Meneghini L, Doshi A, Gouet D, Vilsboll T, Begtrup K, Orsy P, Ranthe MF, Lingvay I. Insulin degludec/liraglutide (IDegLira) maintains glycaemic control and improves clinical outcomes, regardless of pre-trial insulin dose, in people with type 2 diabetes that is uncontrolled on basal insulin. Diabet Med. 2020 Feb;37(2):267-276. doi: 10.1111/dme.14178. Epub 2019 Nov 28.
PubMed 31705547

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?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02420262
Acronym / sponsor ID: NN9068-4185
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 506 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 26 Jul 2015 (actual)
Primary completion: 5 Oct 2016 (actual)
Study completion: 5 Oct 2016 (actual)
First posted: 17 Apr 2015 (estimated)
Results: Posted 7 Dec 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: None (open label)
Number of arms: 2

Arm	Type	Receives
IDegLira	Experimental	Drug: insulin degludec/liraglutide
IGlar plus IAsp	Active comparator	Drug: insulin glargine, Drug: insulin aspart

Who may qualify

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

Key inclusion criteria (7 listed)

Male or female, age at least 18 years at the time of signing informed consent
Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
HbA1c (glycosylated haemoglobin) 7.0-10.0% [53mmol/mol-86mmol/mol] (both inclusive) by central laboratory analysis
Current treatment with IGlar (insulin glargine) for at least 90 calendar days prior to screening
Stable daily dose of IGlar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. Individual fluctuations of plus/minus 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive

Key exclusion criteria (7 listed)

Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening
Anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)
Impaired liver function, defined as alanine aminotransferase (ALT) at least 2.5 times upper limit of normal
Renal impairment eGFR (electronic case report form) below 60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
Screening calcitonin at least 50 ng/L

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/liraglutideOnce daily injected s.c./subcutaneously (under the skin) in combination with metformin.	Drug	IDegLira
insulin glargineOnce daily injected s.c./subcutaneously (under the skin) in combination with metformin.	Drug	IGlar plus IAsp
insulin aspartInjected s.c./subcutaneously (under the skin) before each main meal.	Drug	IGlar plus IAsp

Primary outcome

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

4 secondary outcomes

Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes.
Time frame: Weeks 0-26
Change in Body Weight
Time frame: Week 0, Week 26
Responder for HbA1c Below 7.0%
Time frame: After 26 weeks of treatment
Responder for HbA1c Below or Equal to 6.5 %
Time frame: After 26 weeks of treatment

Results and safety

Results posted to the registry on 7 Dec 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	252	250
IGlar + IAsp	254	249

Primary outcome: Change in HbA1c (Glycosylated Haemoglobin)

Time frame: Week 0, Week 26. Least squares mean (Standard Error). Unit: Percentage of glycosylated haemoglobin

Measure	IDegLira n = 244	IGlar + IAsp n = 245
Value	-1.48 (0.05)	-1.46 (0.05)

IDegLira vs IGlar + IAsp: Treatment contrast: -0.02 (95% CI -0.16 to 0.12), p <0.0001, Mixed Models Analysis

Population analysed: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". 8 subjects in IDegLira and 9 subjects in IGlar + IAsp arm did not contribute to the analysis for this endpoint.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected from the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment (26 weeks + 7 days of follow-up).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IDegLira	12 of 252 (4.8%)	84 of 252 (33.3%)	Not reported
IGlar + IAsp	10 of 253 (4%)	79 of 253 (31.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29483185Billings LK, Doshi A, Gouet D, Oviedo A, Rodbard HW, Tentolouris N, Gron R, Halladin N, Jodar E. Efficacy and Safety of IDegLira Versus Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes Uncontrolled on Metformin and Basal Insulin: The DUAL VII Randomized Clinical Trial. Diabetes Care. 2018 May;41(5):1009-1016. doi: 10.2337/dc17-1114. Epub 2018 Feb 26.
Derived from this study: PubMed 32107930Billings LK, Agner BFR, Altuntas Y, Gron R, Halladin N, Klonoff DC, Tentolouris N, Jodar E. The Benefit of Insulin Degludec/Liraglutide (IDegLira) Compared With Basal-Bolus Insulin Therapy is Consistent Across Participant Subgroups With Type 2 Diabetes in the DUAL VII Randomized Trial. J Diabetes Sci Technol. 2021 May;15(3):636-645. doi: 10.1177/1932296820906888. Epub 2020 Feb 28.
Derived from this study: PubMed 31705547Meneghini L, Doshi A, Gouet D, Vilsboll T, Begtrup K, Orsy P, Ranthe MF, Lingvay I. Insulin degludec/liraglutide (IDegLira) maintains glycaemic control and improves clinical outcomes, regardless of pre-trial insulin dose, in people with type 2 diabetes that is uncontrolled on basal insulin. Diabet Med. 2020 Feb;37(2):267-276. doi: 10.1111/dme.14178. Epub 2019 Nov 28.
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

117 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/liraglutide, insulin glargine and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 117 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 7 inclusion and 7 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 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States, France, Russia, Czechia, Greece 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 7 Dec 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 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 NCT02420262, which also lists 3 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 29 Mar 2018.