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

Conditions: Diabetes Mellitus, Type 1
MedDRA version: 16.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2012-003580-21-IE

Lead Sponsor: ovo Nordisk A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1404

Inclusion Criteria

-Informed consent obtained
-Type 1 diabetes mellitus = 12 months
-Male or female, aged 18 – 75 years
-Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump) treatment = 6
months
-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, selftitration of insulin and attend all scheduled visits
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 1300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 104

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 > 160 mmHg for systolic or > 100 mmHg for diastolic
-History of acute or chronic pancreatitis.
-Screening calcitonin value > 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)