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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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)
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Secondary ID [1]
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2012-000209-63
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Secondary ID [2]
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NN9068-3851
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Universal Trial Number (UTN)
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Trial acronym
DUAL™ III
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes
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Diabetes Mellitus, Type 2
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2)
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Assessment method [1]
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Timepoint [1]
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Week 0, week 26
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Secondary outcome [1]
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Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)
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Assessment method [1]
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Percentage of subjects achieving HbA1c below 7.0% after 26 weeks of treatment.
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Timepoint [1]
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Week 26
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Secondary outcome [2]
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Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)
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Assessment method [2]
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Percentage of responders achieving pre-defined target for HbA1c - HbA1c = 6.5% (48 mmol/mol).
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Timepoint [2]
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Week 26
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Secondary outcome [3]
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Change From Baseline in Body Weight
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Assessment method [3]
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Mean change in body weight after 26 weeks of treatment.
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Timepoint [3]
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Week 0, week 26
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Secondary outcome [4]
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Change From Baseline in Fasting Plasma Glucose (FPG)
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Assessment method [4]
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Mean change in fasting plasma glucose from baseline, after 26 weeks of treatment.
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Timepoint [4]
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Week 0, week 26
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Secondary outcome [5]
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Number of Severe or Minor Hypoglycaemic Episodes
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Assessment method [5]
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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).
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Timepoint [5]
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After 26 weeks of treatment
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Secondary outcome [6]
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Number of Adverse Events (AEs)
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Assessment method [6]
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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.
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Timepoint [6]
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After 26 weeks of treatment
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Secondary outcome [7]
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Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure - Diabetes (TRIM-D)
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Assessment method [7]
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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.
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Timepoint [7]
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Week 0, week 26
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Secondary outcome [8]
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Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ).
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Assessment method [8]
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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.
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Timepoint [8]
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Week 0, week 26
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/08/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
11/03/2014
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Sample size
Target
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Accrual to date
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Final
438
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Novo Nordisk Investigational Site - Coffs Harbour
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Recruitment hospital [2]
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Novo Nordisk Investigational Site - Merewether
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Recruitment hospital [3]
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Novo Nordisk Investigational Site - Keswick
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Recruitment hospital [4]
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Novo Nordisk Investigational Site - Box Hill
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Recruitment hospital [5]
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Novo Nordisk Investigational Site - Melbourne
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Recruitment postcode(s) [1]
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2450 - Coffs Harbour
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Recruitment postcode(s) [2]
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2291 - Merewether
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Recruitment postcode(s) [3]
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5035 - Keswick
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Recruitment postcode(s) [4]
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3128 - Box Hill
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Hawaii
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Illinois
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Indiana
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Kentucky
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United States of America
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Maryland
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Michigan
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Missouri
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Nebraska
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Antibes
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Boulogne Billancourt
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France
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Montigny-les-Metz
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France
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Narbonne
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Nimes
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Sète
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France
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Venissieux
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Budapest
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Debrecen
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Hungary
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Nyíregyhaza
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Hungary
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Székesfehérvár
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Slovakia
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Bratislava
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Kosice
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Slovakia
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Lucenec
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Slovakia
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Nitra
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Slovakia
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Presov
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novo Nordisk A/S
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01676116
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Global Clinical Registry (GCR, 1452)
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Address
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Novo Nordisk A/S
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01676116
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