EUCTR2012-003580-21-NO
Active, not recruiting
Phase 1
The efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetesA 52-week randomised, treat-to-target, placebo-controlled, double-blinded, parallelgroup, multinational, multi-centre trial - ADJUNCT ONE™
ConditionsDiabetes Mellitus, Type 1MedDRA version: 16.0Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsVictoza
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 1
- Sponsor
- ovo Nordisk A/S
- Enrollment
- 1398
- Status
- Active, not recruiting
- Last Updated
- 4 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\-9\.5% (Diabetes Control and Complications Trial (DCCT)), both inclusive, (corresponding to 53\-80 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
Exclusion Criteria
- •\- Prior use of glucagon\-like peptide\-1 (GLP\-1\) receptor agonist or dipeptidyl peptidase IV (DPP\-4\) inhibitors
- •\- Use of any medication (except for insulin), which in the investigator’s opinion could interfere with the glycaemic control or affect the subject’s safety
- •\- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within 1 month) prior to screening
- •\- Existing hypoglycaemic unawareness as judged by the investigator
- •\- Hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening
- •\- Known proliferative retinopathy or maculopathy requiring treatment and/or 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\)
Outcomes
Primary Outcomes
Not specified
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