iraglutide to overweight patients with insulin treated type 2 diabetes

Phase 1

• Conditions: Diabetes Mellitus Type 2; MedDRA version: 14.1Level: PTClassification code 10053247Term: Insulin-requiring type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-001941-42-SE
• Lead Sponsor: Västra Götalandsregionen (VGR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-16
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified