NL-OMON38605
Completed
Phase 3
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 - ADJUNCT ONE*
ovo Nordisk0 sites50 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- diabetes
- Sponsor
- ovo Nordisk
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
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