DiabetesPhase 3DUAL™ IIINCT01676116
The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy
A Phase 3 study testing insulin degludec/liraglutide, liraglutide and exenatide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 109 sites in 5 countries.
Trial summary
This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like peptide-1 (GLP-1) receptor agonist and OAD therapy. 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, liraglutide and exenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 109 sitesin 5 countries
- Study dates
- 29 Aug 2012to 11 Mar 2014
- 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 mellitus
- Glycosylated haemoglobin (HbA1c) 7.0-9.0% (53-75 mmol/mol) (both inclusive)
- Treatment with daily GLP-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg once daily (OD) Victoza® (liraglutide) or 10 microgram twice daily (BID) Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza® (liraglutide) or 5 microgram BID Byetta® (exenatide)) in combination with a stable daily dose of metformin (equal to or above 1500 mg or documented maximum tolerated dose) for 90 days or more prior to screening visit (Visit 1)
- BMI (body mass index) equal to or below 40 kg/m^2
Who cannot join
- Any use of oral anti-diabetic drugs (OADs) (except for metformin, pioglitazone and sulphonylurea) for 90 days or less prior to screening visit (Visit 1)
- Use of any drug (except metformin,pioglitazone, sulphonylurea and GLP-1 receptor agonist) which in the Investigator's opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
- Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)
- Screening calcitonin equal to or above 50 ng/l
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
- Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary, carotid or peripheral artery revascularisation procedures
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- Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator's opinion
- Subjects with a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the type 2 diabetes mellitus), neurological, genitourinary or haematological system that in the opinion of the Investigator may confound the results of the trial or pose additional risk in administering trial products
- History of chronic pancreatitis or idiopathic acute pancreatitis
Trial locations and contacts
109 sites in 5 countries.
109 sites in 5 countries
United States85 sites
Novo Nordisk Investigational Site
Altoona, Pennsylvania, 16602
Novo Nordisk Investigational Site
Arlington, Texas, 76014
Novo Nordisk Investigational Site
Arlington Heights, Illinois, 60004-2315
Novo Nordisk Investigational Site
Atlanta, Georgia, 30318
Novo Nordisk Investigational Site
Austin, Texas, 78731
Novo Nordisk Investigational Site
Berlin, New Jersey, 08009
Novo Nordisk Investigational Site
Birmingham, Alabama, 35216
Novo Nordisk Investigational Site
Bradenton, Florida, 34201
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37404
Novo Nordisk Investigational Site
Colorado Springs, Colorado, 80910
Novo Nordisk Investigational Site
Columbus, Ohio, 43214
Novo Nordisk Investigational Site
Concord, California, 94520
Novo Nordisk Investigational Site
Dallas, Texas, 75218
Novo Nordisk Investigational Site
Dallas, Texas, 75231
Novo Nordisk Investigational Site
Dayton, Ohio, 45439
Novo Nordisk Investigational Site
Encino, California, 91436
Novo Nordisk Investigational Site
Fair Oaks, California, 95628
Novo Nordisk Investigational Site
Flemington, New Jersey, 08822-5763
Novo Nordisk Investigational Site
Fort Myers, Florida, 33912-4343
Novo Nordisk Investigational Site
Fort Worth, Texas, 76113
Novo Nordisk Investigational Site
Fresno, California, 93720
Novo Nordisk Investigational Site
Goodyear, Arizona, 85395
Novo Nordisk Investigational Site
Greenbrae, California, 94904
Novo Nordisk Investigational Site
Hamilton, New Jersey, 08619
Novo Nordisk Investigational Site
Henderson, Nevada, 89052-2649
Novo Nordisk Investigational Site
Honolulu, Hawaii, 96814
Novo Nordisk Investigational Site
Houston, Texas, 77074
Novo Nordisk Investigational Site
Houston, Texas, 77095
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46254
Novo Nordisk Investigational Site
Jacksonville, Florida, 32204
Novo Nordisk Investigational Site
Jacksonville, Florida, 32207
Novo Nordisk Investigational Site
Jacksonville, Florida, 32216
Novo Nordisk Investigational Site
Jacksonville, Florida, 32258
Novo Nordisk Investigational Site
Jellico, Tennessee, 37762
Novo Nordisk Investigational Site
Kalamazoo, Michigan, 49048
Novo Nordisk Investigational Site
Kingsport, Tennessee, 37660
Novo Nordisk Investigational Site
Lancaster, California, 93534
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89128
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, 08648
Novo Nordisk Investigational Site
Lexington, Kentucky, 40503
Novo Nordisk Investigational Site
Lomita, California, 90717
Novo Nordisk Investigational Site
Long Beach, California, 90806
Novo Nordisk Investigational Site
Mesa, Arizona, 85206
Novo Nordisk Investigational Site
Miami, Florida, 33135
Novo Nordisk Investigational Site
Miami, Florida, 33136
Novo Nordisk Investigational Site
Miami, Florida, 33155
Novo Nordisk Investigational Site
Miami, Florida, 33156
Novo Nordisk Investigational Site
Miami Springs, Florida, 33166
Novo Nordisk Investigational Site
Mineola, New York, 11501
Novo Nordisk Investigational Site
Montclair, California, 91763
Novo Nordisk Investigational Site
Morehead City, North Carolina, 28557
Novo Nordisk Investigational Site
Myrtle Beach, South Carolina, 29572
Novo Nordisk Investigational Site
Nashua, New Hampshire, 03063
Novo Nordisk Investigational Site
Nashville, Tennessee, 37212
Novo Nordisk Investigational Site
North Massapequa, New York, 11758-1802
Novo Nordisk Investigational Site
Northridge, California, 91325
Novo Nordisk Investigational Site
Omaha, Nebraska, 68124
Novo Nordisk Investigational Site
Orem, Utah, 84058
Novo Nordisk Investigational Site
Orlando, Florida, 32806
Novo Nordisk Investigational Site
Phoenix, Arizona, 85018
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15243
Novo Nordisk Investigational Site
Plano, Texas, 75075
Novo Nordisk Investigational Site
Plant City, Florida, 33563
Novo Nordisk Investigational Site
Reno, Nevada, 89502-0111
Novo Nordisk Investigational Site
Richmond, Virginia, 23219
Novo Nordisk Investigational Site
Rockville, Maryland, 20852
Novo Nordisk Investigational Site
Roswell, Georgia, 30076
Novo Nordisk Investigational Site
Round Rock, Texas, 78681
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, 78249
Novo Nordisk Investigational Site
San Mateo, California, 94401
Novo Nordisk Investigational Site
San Ramon, California, 94583
Novo Nordisk Investigational Site
Schertz, Texas, 78154
Novo Nordisk Investigational Site
St. George, Utah, 84790
Novo Nordisk Investigational Site
Sugar Land, Texas, 77478
Novo Nordisk Investigational Site
Sumter, South Carolina, 29150-1900
Novo Nordisk Investigational Site
Tarzana, California, 91356-3551
Novo Nordisk Investigational Site
Toms River, New Jersey, 08753-2975
Novo Nordisk Investigational Site
Troy, Michigan, 48098
Novo Nordisk Investigational Site
Tullahoma, Tennessee, 37388
Novo Nordisk Investigational Site
Van Nuys, California, 91405
Novo Nordisk Investigational Site
West Seneca, New York, 14224
Novo Nordisk Investigational Site
Winter Haven, Florida, 33880
France8 sites
Novo Nordisk Investigational Site
Antibes, 06600
Novo Nordisk Investigational Site
Boulogne-Billancourt, 92100
Novo Nordisk Investigational Site
La Rochelle, 17019
Novo Nordisk Investigational Site
Montigny-lès-Metz, 57950
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Nîmes, 30006
Novo Nordisk Investigational Site
Sète, 34200
Novo Nordisk Investigational Site
Vénissieux, 69200
Slovakia7 sites
Novo Nordisk Investigational Site
Bratislava, 811 08
Novo Nordisk Investigational Site
Bratislava, 831 01
Novo Nordisk Investigational Site
Bratislava, 851 01
Novo Nordisk Investigational Site
Košice, 040 01
Novo Nordisk Investigational Site
Lučenec, 98401
Novo Nordisk Investigational Site
Nitra, 94 911
Novo Nordisk Investigational Site
Prešov, 080 01
Australia5 sites
Novo Nordisk Investigational Site
Box Hill, Victoria, 3128
Novo Nordisk Investigational Site
Coffs Harbour, New South Wales, 2450
Novo Nordisk Investigational Site
Keswick, South Australia, 5035
Novo Nordisk Investigational Site
Melbourne, Victoria, 3004
Novo Nordisk Investigational Site
Merewether, New South Wales, 2291
Hungary4 sites
Novo Nordisk Investigational Site
Budapest, 1042
Novo Nordisk Investigational Site
Debrecen, 4043
Novo Nordisk Investigational Site
Nyíregyhaza, 4400
Novo Nordisk Investigational Site
Székesfehérvár, 8000
About this study
Official title: The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy (DUAL™ III -GLP-1 Switch)
This trial is conducted in Europe, Oceania and the United States of America (USA).
The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like peptide-1 (GLP-1) receptor agonist and OAD therapy.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin degludec/liraglutide, liraglutide, exenatide
- 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
Injected subcutaneously (under the skin) once daily. Dose individually adjusted. Subjects will continue their pre-trial OAD treatment without changing the frequency or dose throughout the trial.
liraglutideDrug
Subjects will continue on their pre-trial treatment of liraglutide (Victoza®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial.
exenatideDrug
Subjects will continue on their pre-trial treatment of exenatide (Byetta®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial.
| Study group | Role | What they receive |
|---|---|---|
| Insulin degludec/liraglutide + OADs | Experimental | Not described Receives: Drug: insulin degludec/liraglutide |
| Liraglutide or exenatide + OADs | Active comparator | Not described Receives: Drug: liraglutide; Drug: exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2)
Measured: Week 0, week 26
Secondary outcomes (8)
Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)
Percentage of subjects achieving HbA1c below 7.0% after 26 weeks of treatment.
Measured: Week 26
Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)
Percentage of responders achieving pre-defined target for HbA1c - HbA1c ≤ 6.5% (48 mmol/mol).
Measured: Week 26
Change From Baseline in Body Weight
Mean change in body weight after 26 weeks of treatment.
Measured: Week 0, week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Mean change in fasting plasma glucose from baseline, after 26 weeks of treatment.
Measured: Week 0, week 26
Number of Severe or Minor Hypoglycaemic Episodes
Rate (events per 100 patient years of exposure) of treatment-emergent confirmed hypoglycaemic episodes. The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes. Severe hypoglycaemia was categorised as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or PG <3.1 mmol/L (56 mg/dL), and which was handled by the subject himself/herself, or any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or PG value <3.1 mmol/L (56 mg/dL).
Measured: After 26 weeks of treatment
Number of Adverse Events (AEs)
Rate (events per 100 exposure years) of treatment-emergent adverse events (an event that had onset date (or an increase in severity) on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment) which occurred during the 26 weeks of treatment.
Measured: After 26 weeks of treatment
Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure - Diabetes (TRIM-D)
The patient related outcome is calculated based on TRIM-D questionnaire. The TRIM-D questionnaire consists of 5 sub-domains (treatment burden, daily life, diabetes management, compliance and psychological health), where each question is scored to a 1-5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D individual sub-domain scores and total score are later transformed to a 0-100 scale for analysis. The mean change in scores from baseline to 26 weeks for all the individual sub domains and total scores are presented here.
Measured: Week 0, week 26
Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ).
Mean change in diabetes treatment satisfaction questionnaire (DTSQs) scores from baseline. The scores ranged from 0 to 6. Higher total score on a 0-6 point scale indicates a general higher treatment satisfaction, whereas higher score on perceived frequency of hyperglycaemia and perceived frequency of hypoglycaemia indicate that blood glucose levels are out of the target range.
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.
- First posted30 Aug 2012 (estimated)
- Study start29 Aug 2012
- Primary completion11 Mar 2014
- Study completion11 Mar 2014
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
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676116
- Sponsor's protocol ID
- NN9068-3851
- Other IDs
- 2012-000209-63, U1111-1127-1321
- Acronym
- DUAL™ III
- Status last verified
- Dec 2018
- First submitted
- 28 Aug 2012
- Last updated
- 3 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Linjawi S, Bode BW, Chaykin LB, Courreges JP, Handelsman Y, Lehmann LM, Mishra A, Simpson RW. The Efficacy of IDegLira (Insulin Degludec/Liraglutide Combination) in Adults with Type 2 Diabetes Inadequately Controlled with a GLP-1 Receptor Agonist and Oral Therapy: DUAL III Randomized Clinical Trial. Diabetes Ther. 2017 Feb;8(1):101-114. doi: 10.1007/s13300-016-0218-3. Epub 2016 Dec 10.
PubMed 27943107Lingvay 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 30383495Natale 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
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
- The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy (DUAL™ III -GLP-1 Switch)
- ClinicalTrials.gov ID
- NCT01676116
- Acronym / sponsor ID
- DUAL™ III / NN9068-3851
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2012 (actual)
- Primary completion
- 11 Mar 2014 (actual)
- Study completion
- 11 Mar 2014 (actual)
- First posted
- 30 Aug 2012 (estimated)
- Results
- Posted 9 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is conducted in Europe, Oceania and the United States of America (USA).
The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like peptide-1 (GLP-1) receptor agonist and OAD therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin degludec/liraglutide + OADs | Experimental | Drug: insulin degludec/liraglutide |
| Liraglutide or exenatide + OADs | Active comparator | Drug: liraglutide, Drug: exenatide |
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 mellitus
- Glycosylated haemoglobin (HbA1c) 7.0-9.0% (53-75 mmol/mol) (both inclusive)
- Treatment with daily GLP-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg once daily (OD) Victoza® (liraglutide) or 10 microgram twice daily (BID) Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza® (liraglutide) or 5 microgram BID Byetta® (exenatide)) in combination with a stable daily dose of metformin (equal to or above 1500 mg or documented maximum tolerated dose) for 90 days or more prior to screening visit (Visit 1)
- BMI (body mass index) equal to or below 40 kg/m^2
Key exclusion criteria (9 listed)
- Any use of oral anti-diabetic drugs (OADs) (except for metformin, pioglitazone and sulphonylurea) for 90 days or less prior to screening visit (Visit 1)
- Use of any drug (except metformin,pioglitazone, sulphonylurea and GLP-1 receptor agonist) which in the Investigator's opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
- Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)
- Screening calcitonin equal to or above 50 ng/l
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
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/liraglutideInjected subcutaneously (under the skin) once daily. Dose individually adjusted. Subjects will continue their pre-trial OAD treatment without changing the frequency or dose throughout the trial. | Drug | Insulin degludec/liraglutide + OADs |
| liraglutideSubjects will continue on their pre-trial treatment of liraglutide (Victoza®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial. | Drug | Liraglutide or exenatide + OADs |
| exenatideSubjects will continue on their pre-trial treatment of exenatide (Byetta®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial. | Drug | Liraglutide or exenatide + OADs |
Primary outcome
Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2)
Time frame: Week 0, week 26
8 secondary outcomes
Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)
Time frame: Week 26
Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)
Time frame: Week 26
Change From Baseline in Body Weight
Time frame: Week 0, week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame: Week 0, week 26
Number of Severe or Minor Hypoglycaemic Episodes
Time frame: After 26 weeks of treatment
Number of Adverse Events (AEs)
Time frame: After 26 weeks of treatment
Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure - Diabetes (TRIM-D)
Time frame: Week 0, week 26
Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ).
Time frame: Week 0, week 26
Results and safety
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.
- Results publication: PubMed 27943107Linjawi S, Bode BW, Chaykin LB, Courreges JP, Handelsman Y, Lehmann LM, Mishra A, Simpson RW. The Efficacy of IDegLira (Insulin Degludec/Liraglutide Combination) in Adults with Type 2 Diabetes Inadequately Controlled with a GLP-1 Receptor Agonist and Oral Therapy: DUAL III Randomized Clinical Trial. Diabetes Ther. 2017 Feb;8(1):101-114. doi: 10.1007/s13300-016-0218-3. Epub 2016 Dec 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
109 sites in 5 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, liraglutide and exenatide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 109 sites in 5 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 109 sites in United States, France, Slovakia, Australia, Hungary. 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 9 Jul 2018). 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) From Baseline (Randomisation, Visit 2) (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 NCT01676116, 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 3 Jan 2019.