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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01676116




Registration number
NCT01676116
Ethics application status
Date submitted
28/08/2012
Date registered
30/08/2012
Date last updated
3/01/2019

Titles & IDs
Public 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
Scientific 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)
Secondary ID [1] 0 0
2012-000209-63
Secondary ID [2] 0 0
NN9068-3851
Universal Trial Number (UTN)
Trial acronym
DUAL™ III
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - insulin degludec/liraglutide
Treatment: Drugs - liraglutide
Treatment: Drugs - exenatide

Experimental: Insulin degludec/liraglutide + OADs -

Active comparator: Liraglutide or exenatide + OADs -


Treatment: Drugs: insulin degludec/liraglutide
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.

Treatment: Drugs: liraglutide
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.

Treatment: Drugs: exenatide
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2)
Timepoint [1] 0 0
Week 0, week 26
Secondary outcome [1] 0 0
Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)
Timepoint [1] 0 0
Week 26
Secondary outcome [2] 0 0
Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)
Timepoint [2] 0 0
Week 26
Secondary outcome [3] 0 0
Change From Baseline in Body Weight
Timepoint [3] 0 0
Week 0, week 26
Secondary outcome [4] 0 0
Change From Baseline in Fasting Plasma Glucose (FPG)
Timepoint [4] 0 0
Week 0, week 26
Secondary outcome [5] 0 0
Number of Severe or Minor Hypoglycaemic Episodes
Timepoint [5] 0 0
After 26 weeks of treatment
Secondary outcome [6] 0 0
Number of Adverse Events (AEs)
Timepoint [6] 0 0
After 26 weeks of treatment
Secondary outcome [7] 0 0
Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure - Diabetes (TRIM-D)
Timepoint [7] 0 0
Week 0, week 26
Secondary outcome [8] 0 0
Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ).
Timepoint [8] 0 0
Week 0, week 26

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/03/2014
Sample size
Target
Accrual to date
Final
438
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Coffs Harbour
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Merewether
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Keswick
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Box Hill
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2291 - Merewether
Recruitment postcode(s) [3] 0 0
5035 - Keswick
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Hawaii
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
Nevada
Country [16] 0 0
United States of America
State/province [16] 0 0
New Hampshire
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
South Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Utah
Country [26] 0 0
United States of America
State/province [26] 0 0
Virginia
Country [27] 0 0
France
State/province [27] 0 0
Antibes
Country [28] 0 0
France
State/province [28] 0 0
Boulogne Billancourt
Country [29] 0 0
France
State/province [29] 0 0
LA ROCHELLE cedex
Country [30] 0 0
France
State/province [30] 0 0
Montigny-les-Metz
Country [31] 0 0
France
State/province [31] 0 0
Narbonne
Country [32] 0 0
France
State/province [32] 0 0
Nimes
Country [33] 0 0
France
State/province [33] 0 0
Sète
Country [34] 0 0
France
State/province [34] 0 0
Venissieux
Country [35] 0 0
Hungary
State/province [35] 0 0
Budapest
Country [36] 0 0
Hungary
State/province [36] 0 0
Debrecen
Country [37] 0 0
Hungary
State/province [37] 0 0
Nyíregyhaza
Country [38] 0 0
Hungary
State/province [38] 0 0
Székesfehérvár
Country [39] 0 0
Slovakia
State/province [39] 0 0
Bratislava
Country [40] 0 0
Slovakia
State/province [40] 0 0
Kosice
Country [41] 0 0
Slovakia
State/province [41] 0 0
Lucenec
Country [42] 0 0
Slovakia
State/province [42] 0 0
Nitra
Country [43] 0 0
Slovakia
State/province [43] 0 0
Presov

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT01676116
Trial related presentations / 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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01676116