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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/NCT01836523
Registration number
NCT01836523
Ethics application status
Date submitted
17/04/2013
Date registered
22/04/2013
Date last updated
6/03/2017
Titles & IDs
Public title
The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes
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Scientific title
The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes. A 52-week Randomised, Treat-to-target, Placebo-controlled, Double Blinded, Parallel Group, Multinational, Multi-centre Trial
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Secondary ID [1]
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2012-003580-21
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Secondary ID [2]
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NN9211-3919
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Universal Trial Number (UTN)
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Trial acronym
ADJUNCT ONE™
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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 1
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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 - liraglutide
Treatment: Drugs - placebo
Treatment: Drugs - liraglutide
Treatment: Drugs - placebo
Treatment: Drugs - liraglutide
Treatment: Drugs - placebo
Experimental: Liraglutide 0.6 mg + insulin -
Experimental: Liraglutide 1.2 mg + insulin -
Experimental: Liraglutide 1.8 mg + insulin -
Placebo Comparator: Liraglutide placebo 0.6 mg + insulin -
Placebo Comparator: Liraglutide placebo 1.2 mg + insulin -
Placebo Comparator: Liraglutide placebo 1.8 mg + insulin -
Treatment: Drugs: liraglutide
Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
Treatment: Drugs: placebo
Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
Treatment: Drugs: liraglutide
Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
Treatment: Drugs: placebo
Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
Treatment: Drugs: liraglutide
Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
Treatment: Drugs: placebo
Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
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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 From Baseline in HbA1c (Glycosylated Haemoglobin)
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Assessment method [1]
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Change from baseline in HbA1c at week 52. Missing values were handled by using a mixed model for repeated measurements (MMRM).
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Timepoint [1]
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Week 0, week 52
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Primary outcome [2]
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Change From Baseline in Body Weight
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Assessment method [2]
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Change from baseline in body weight at week 52. Missing values were handled by using a MMRM.
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Timepoint [2]
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Week 0, week 52
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Primary outcome [3]
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Change From Baseline in Total Daily Insulin Dose
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Assessment method [3]
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Change from baseline in total daily insulin dose at week 52. Change from baseline was represented in terms of ratio to baseline for insulin dose i.e. Total daily insulin dose at week 52/total daily insulin dose at baseline. Missing values were handled by using a MMRM.
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Timepoint [3]
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Week 0, week 52
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Secondary outcome [1]
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Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes
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Assessment method [1]
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This is a confirmatory secondary endpoint. Symptomatic hypoglycaemic episodes were defined as: 1) Severe according to the American Diabetes Association (ADA) classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. OR 2) Self-monitoring of plasma glucose value of <3.1 mmol/L, with symptoms consistent with hypoglycaemia. A treatment emergent episode is defined as an episode with onset date (or increase in severity) on or after first day of exposure to randomised treatment and up to last dose + 7 days.
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Timepoint [1]
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Weeks 0-52
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Eligibility
Key inclusion criteria
- - Informed consent obtained
- - Type 1 diabetes mellitus for 12 months or longer
- - Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump)
treatment for 6 months or longer
- - Stable insulin treatment for the last 3 months prior to Screening, as judged and
documented by the investigator
- - HbA1c 7.0-10% (Diabetes Control and Complications Trial (DCCT)), both inclusive,
(corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry
(IFCC))
- - Ability and willingness to comply with all protocol procedures e.g. correct handling
of trial product, complete trial related questionnaires, diaries, self-monitoring of
plasma glucose, self titration of insulin and attend all scheduled visits
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Minimum age
18
Years
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Maximum age
75
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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
- - Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl
peptidase IV (DPP-4) inhibitors
- - Use of any medication, which in the investigator's opinion could interfere with the
glycaemic control or affect the subject's safety.Premix insulin is not allowed
- - Known proliferative retinopathy or maculopathy requiring acute treatment
- - Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged
by the investigator
- - Uncontrolled/ untreated blood pressure at screening above 160 mmHg for systolic or
above 100 mmHg for diastolic
- - History of acute or chronic pancreatitis
- - Screening calcitonin value equal to or above 50 ng/L
- - Personal or family history of medullary thyroid carcinoma or Multiple Endocrine
Neoplasia type 2 (MEN2)
- - Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin
cancer or squamous cell skin cancer)
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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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
1/11/2013
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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
1/06/2015
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Sample size
Target
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Accrual to date
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Final
1398
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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 - Broadmeadow
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Novo Nordisk Investigational Site - Elizabeth Vale
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Novo Nordisk Investigational Site - Keswick
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Novo Nordisk Investigational Site - Parkville
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2292 - Broadmeadow
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5112 - Elizabeth Vale
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5035 - Keswick
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3004 - Melbourne
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3050 - Parkville
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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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Ethics approval
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Summary
Brief summary
This trial is conducted globally. The aim of the trial is to confirm the efficacy and safety
of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. The total
trial duration per subject is approximately 58 weeks.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01836523
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Trial related presentations / publications
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Contacts
Principal investigator
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Global Clinical Registry (GCR, 1452)
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Novo Nordisk A/S
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01836523
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