The efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes; A 26-weeks randomised, insulin capped, placebo-controlled, double-blinded, parallelgroup, multinational, multi-centre trial

Phase 3

Completed

Conditions: diabetes
10018424

Registration Number: NL-OMON40721

Lead Sponsor: ovo Nordisk

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

-Informed consent obtained
-Male or female, aged *18 years
-Type 1 diabetes mellitus* 12 months
-Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump) treatment * 6 months
- Stable insulin treatment for the last 3 month prior to Screening, as judged and documented by the investigator
- HbA1c 7.0-10% (53-86 mmol/mol) both inclusive

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change from baseline in glycosylated haemoglobin (HbA1c) after 26 weeks of<br /><br>treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Change from baseline in body weight after 26 weeks of treatment<br /><br>Number of treatment-emergent symptomatic hypoglycaemic episodes during 26 weeks<br /><br>of treatment</p><br>