EUCTR2012-003580-21-PL
Active, not recruiting
Not Applicable
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: 18.0Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsVictoza
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 1
- Sponsor
- ovo Nordisk A/S
- Enrollment
- 1404
- Status
- Active, not recruiting
- Last Updated
- 10 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, (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
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)
Outcomes
Primary Outcomes
Not specified
Similar Trials
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 trialdiabetes10018424NL-OMON38605ovo Nordisk50
Active, not recruiting
Phase 1
The efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetesDiabetes Mellitus, Type 1MedDRA version: 16.0Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]EUCTR2012-003580-21-NOovo Nordisk A/S1,398
Active, not recruiting
Phase 1
The efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetesEUCTR2012-003580-21-BEovo Nordisk A/S1,398
Active, not recruiting
Not Applicable
The efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetesDiabetes Mellitus, Type 1MedDRA version: 16.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]EUCTR2012-003580-21-SEovo Nordisk A/S1,404
Active, not recruiting
Not Applicable
The efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetesEUCTR2012-003580-21-NLovo Nordisk A/S1,404