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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01336023




Registration number
NCT01336023
Ethics application status
Date submitted
13/04/2011
Date registered
15/04/2011
Date last updated
19/02/2018

Titles & IDs
Public title
Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Subjects With Type 2 Diabetes
Scientific title
A 26 Week Randomised, Parallel Three-arm, Open-label, Multi-centre, Multinational Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide Versus Insulin Degludec or Liraglutide Alone, in Subjects With Type 2 Diabetes Treated With 1-2 Oral Anti-diabetic Drugs (OADs)With a 26 Week Extension
Secondary ID [1] 0 0
U1111-1119-1174
Secondary ID [2] 0 0
NN9068-3697
Universal Trial Number (UTN)
Trial acronym
DUALâ„¢ I
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 - insulin degludec
Treatment: Drugs - liraglutide

Experimental: IDeg -

Experimental: IDegLira -

Experimental: Lira -


Treatment: Drugs: insulin degludec/liraglutide
Insulin degludec/liraglutide treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). Insulin degludec/liraglutide is injected subcutaneously (under the skin) once daily.

Treatment: Drugs: insulin degludec
Insulin degludec treatment will be initiated with 10 U and titrated (individually adjusted) twice weekly according to the mean SMPG (fasting). Insulin degludec is injected subcutaneously (under the skin) once daily.

Treatment: Drugs: liraglutide
Liraglutide will be started with 0.6 mg and subsequent 0.6 mg weekly dose escalation to 1.8 mg. Liraglutide dose of 1.8 mg/day will be continued for the remaining part of the trial. Liraglutide is injected subcutaneously (under the skin) once daily.

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

Outcomes
Primary outcome [1] 0 0
Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26. - Values of mean change in HbA1c.
Timepoint [1] 0 0
Week 0, week 26
Secondary outcome [1] 0 0
Mean Change From Baseline in Body Weight at Week 26 - Values of mean change in body weight.
Timepoint [1] 0 0
Week 0, Week 26
Secondary outcome [2] 0 0
Number of Hypoglycaemic Episodes - Reported hypoglycemaic episodes are number of hypoglycemic events per 100 patient years of exposure.
Timepoint [2] 0 0
Weeks 0-26
Secondary outcome [3] 0 0
Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test - Values of mean change in normalised iAUC0-4h values based on LOCF data derived from the glucose concentration profiles during a meal test. The meal test was performed at selected sites at baseline and after 26 weeks of treatment in the main trial period. The incremental AUC was calculated using the trapezoidal method and the resulting area was divided length of the observation period to yield the (normalised) prandial increment in mmol/L using the available valid glucose observations and the associated actual elapsed time point.
Timepoint [3] 0 0
Week 0, Week 26
Secondary outcome [4] 0 0
Mean Actual Daily Insulin Dose - Mean of the actual doses recorded at visit 28 (Week 26).
Timepoint [4] 0 0
Week 26

Eligibility
Key inclusion criteria
- Subjects with type 2 diabetes

- HbA1c 7.0-10.0 % (both inclusive) with the aim of a median HbA1c of 8.3%. Accordingly,
when approximately 50% of the randomised subjects have a HbA1c above 8.3%, the
remaining subjects randomised must have a HbA1c of below or equal to 8.3%, or when
approximately 50% of the randomised subjects have a HbA1c of below or equal to 8.3%,
the remaining subjects randomised must have a HbA1c above 8.3%

- Male or female, age 18 years or above (Taiwan: 20 years or above for a site 653 in
Taiwan: Taichung Veterans General Hospital)

- Subjects on stable dose of 1-2 OADs (metformin [at least 1500 mg or max tolerated
dose] or metformin [at least 1500 mg or max tolerated dose] + pioglitazone [at least
30 mg]) for at least 90 days prior to screening

- Body Mass Index (BMI) maximum 40 kg/m^2
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Treatment with insulin (except for short-term treatment due to intercurrent illness at
the discretion of the Investigator)

- Treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (eg exenatide,
liraglutide), sulphonylurea or dipeptidyl peptidase 4 (DPP-4) inhibitors within 90
days prior to trial

- Impaired liver function, defined as alanine aminotransferese (ALAT) at least 2.5 times
Upper Normal Range (UNR) (one retest analysed at the central laboratory within a week
from first sample taken is permitted with the result of the last sample being the
conclusive)

- Impaired renal function defined as serum-creatinine at least 133 mcmol/l (at least 1.5
mg/dl) for males and at least 125 mcmol/l (at least 1.4) for females, or as allowed
according to local contraindications for metformin (one retest analysed at the central
laboratory within a week from first sample taken is permitted with the result of the
last sample being the conclusive)

- Screening calcitonin at least 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 12 months and planned coronary, carotid or peripheral artery revascularisation
procedures

- Severe uncontrolled treated or untreated hypertension (systolic blood pressure at
least 180 mm Hg or diastolic blood pressure at least 100 mm Hg)

- Acute treatment required proliferative retinopathy or maculopathy (macular oedema)

- 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Novo Nordisk Investigational Site - Broadmeadow
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Novo Nordisk Investigational Site - Camperdown
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Novo Nordisk Investigational Site - Coffs Harbour
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Novo Nordisk Investigational Site - Keswick
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Novo Nordisk Investigational Site - East Ringwood
Recruitment hospital [8] 0 0
Novo Nordisk Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
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2450 - Coffs Harbour
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2751 - Penrith
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4131 - Meadowbrook
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5035 - Keswick
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3135 - East Ringwood
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3004 - Melbourne
Recruitment outside Australia
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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 globally. The aim of this trial is to compare the efficacy and safety
of insulin degludec/liraglutide (IDegLira) versus insulin degludec (IDeg) and liraglutide
(Lira) in subjects with type 2 diabetes. Subjects are to continue their pre-trial treatment
with metformin or metformin + pioglitazone throughout the entire trial.
Trial website
https://clinicaltrials.gov/show/NCT01336023
Trial related presentations / 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.
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
Other publications