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, parallelgroup, multinational, multi-centre trial

Phase 3

Completed

Conditions: diabetes
10018424

Registration Number: NL-OMON38605

Lead Sponsor: ovo Nordisk

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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 month prior to Screening, as judged and documented by the investigator
- HbA1c 7.0-10% (Diabetes Control and Complications Trial (DCCT)), both inclusive
- 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

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
- Known proliferative retinopathy or maculopathy requiring 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 HbA1c after 52 weeks of treatment<br /><br>* Change from baseline in body weight after 52 weeks of treatment<br /><br>* Change from baseline in total daily insulin dose after 52 weeks of treatment</p><br>

Secondary Outcome Measures