The efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2012-005778-74-NL
• Date of registration: 06/03/2014
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: The efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes
• Scientific title: The efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes. A 26 week randomised, insulin capped, placebo-controlled, double-blind, parallel group, multinational, multi-centre trial - ADJUNCT TWO™
• Date of first enrolment: 09/05/2014
• Target sample size: 804
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005778-74
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 6

Countries of recruitment

Austria, Belgium, Bulgaria, Canada, Denmark, European Union, Finland, Netherlands, South Africa, Spain, Sweden, United States

Contacts

• Name: Global Clinical Registry (GCR,1452)
• Affiliation: Novo Nordisk A/S

• Name: Global Clinical Registry (GCR,1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion criteria:
1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
2. Male or female, aged = 18 years at the time of signing informed consent
3. Type 1 diabetes mellitus (as diagnosed clinically) = 12 months prior to Visit 1 (i.e. screening)
4. Treatment with basal bolus or CSII (continuous subcutaneous insulin infusion, insulin pump) treatment = 6 months prior to Visit 1 (i.e. screening)
5. Stable insulin treatment = 3 months prior to Visit 1 (i.e. screening), as judged and documented by the investigator
6. HbA1c 7.0–10.0 % (Diabetes Control and Complications Trial (DCCT)), both inclusive, by central laboratory analysis (Visit 1, screening) corresponding to 53–86 mmol/mol (International Federation of Clinical Chemistry (IFCC))
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 744
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion criteria:
1. Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPPIV) inhibitors
2. Use of any medication, which in the investigator’s opinion could interfere with the glycaemic control (e.g. systemic corticosteroids, pramlintide (Symlin®)) or affect the subject’s safety. Premix insulin is not allowed
3. Known proliferative retinopathy or maculopathy requiring acute treatment
4. Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator
5. Uncontrolled/ untreated blood pressure at screening (Visit 1) (after resting for 5 min) while sitting > 160 mmHg for systolic or >100 mmHg for diastolic (repeated measurement at Visit 2 (prior to performing the trial related activities) is allowed to exclude white-coat hypertension)
6. History of acute or chronic pancreatitis
7. Screening (Visit 1) calcitonin value = 50 ng/L
8. Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (MEN2)
9. Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 1
MedDRA version: 16.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

Trade Name: Victoza
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: LIRAGLUTIDE
CAS Number: 204656-20-2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6.0-
Pharmaceutical form of the placebo: Solution for injection in pre-filled pen
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Secondary Objective: 1. To confirm superiority of liraglutide compared to placebo, both adjunct to insulin treatment, with regards to body weight loss after 26 weeks of treatment in subjects with established type 1 diabetes in inadequate glycaemic control.
2. To evaluate safety and tolerability of liraglutide compared to placebo, both adjunct to insulin treatment, during 26 weeks of treatment in subjects with type 1 diabetes in inadequate glycaemic control.

Main Objective: To confirm superiority of liraglutide compared to placebo, both adjunct to insulin treatment, on glycaemic control, after 26 weeks of treatment in subjects with established type 1 diabetes in inadequate glycaemic control.

Primary end point(s): Change from baseline in glycosylated haemoglobin (HbA1c)

Timepoint(s) of evaluation of this end point: After 26 weeks of treatment

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. After 26 weeks of treatment
2. During 26 weeks of treatment

Secondary end point(s): 1. Change from baseline in body weight
2. Number of treatment-emergent symptomatic hypoglycaemic episodes

Secondary ID(s)

2012-005778-74-AT

NN9211-4083

Source(s) of Monetary Support

Novo Nordisk A/S