EUCTR2012-001941-42-SEActive, not recruitingPhase 1
Addition of liraglutide to overweight patients with type 2 diabetes treated with multiple daily insulin injections (MDI) with inadequate glycaemic control
Västra Götalandsregionen (VGR)0 sites120 target enrollmentStarted: July 16, 2012Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Informed consent obtained before trial-related activities (i.e., any activity that would not have been performed during routine patient management)
- •Type 2 diabetes
- •Adult patients over 18 years of age and less than 75 years of age
- •HbA1c greater than 8.0% (NGSP standard=DCCT standard)=64 mmol/mol (IFCC standard) and less than 11.5% (102 mmol/mol)
- •Treated with MDI for at least the last 6 months
- •Treated with/without metformin as only diabetes therapy apart from insulin
- •Fasting C-peptide of 0.2 nmol/l or greater (ref. 0.25-0.75nmol/l)
- •BMI greater than 28 kg/m2 and less than 45 kg/m2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 78
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
Exclusion Criteria
- •Type 1 diabetes
- •Fasting glucose less than 7.0 mmol/l or greater than 15 mmol/l
- •Unstable cardiovascular disease, NYHA Class II or greater heart failure , new symptoms of cardiovascular disease)
- •Proliferative diabetic retinopathy or clinically significant macula oedema. Retinal photograph should not be older than 3 years.
- •Systemic glucocorticoid treatment during the last 3 months
- •Acute coronary syndrome, stroke, coronary artery intervention or myocardial infarction during the previous 6 months
- •Creatinine greater than 130 micromol/l
- •Liver transaminases greater than double of the normal reference interval
- •Treatment with other oral antidiabetic agents than metformin during the previous 3 months
- •Treatment with GLP-1 receptor agonists within 90 days of screening
- •Severe psychiatric disorder (untreated severe depression, schizophrenia, dementia or severe alcohol or drug abuse)
- •Frequent non-severe hypoglycaemia (greater than 2 times per week) or any severe hypoglycaemia during the previous month.
- •Hypoglycaemic unawareness
- •Current cancer or diagnosis of cancer in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer).
- •Personal history of non-familial thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN2)
- •Screening calcitonin values greater than 50 ng/l
- •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice; e.g. oral contraceptive pills and intrauterine device (IUD)).
- •Blood pressure greater than 160/100 mmHg
- •Need for continuous use of paracetamol. During the 3 periods of 7 days with CGM, paracetamol cannot be used. Alternative pain killers can be substituted if plausible because paracetamol is the only medication influencing CGM results.
- •History of chronic or acute pancreatitis
- •Inflammatory Bowel Disease
Investigators
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