Addition of Liraglutide to Patients With Type 2 Diabetes Treated With Multiple Daily Insulin Injections

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Liraglutide, a GLP-1-analogue has been shown to be an effective treatment option in patients on oral anti-diabetes therapy with beneficial effects on both glycaemic control and weight. However, to date there are no clinical trials of liraglutide added to insulin therapy, a population of patients generally having worse glycaemic control and weight gain. In clinical guidelines, use of multiple daily insulin injections (MDI) is usually the final therapeutic option for type 2 diabetic patients.

The primary study aim is to evaluate whether the addition of liraglutide, compared to placebo, reduces the HbA1c level for overweight and obese type 2 diabetes patients with inadequate glycaemic control treated with multiple daily insulin injections (MDI). MDI is defined as treatment with any basal insulin combined with separate meal time insulin injections before the main meals, i.e. an insulin regimen with premixed insulin is not considered as MDI.

The planned study duration is 24 weeks and includes 120 patients at 15 centers in Sweden.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vastra Gotaland Region
• Collaborator: Novo Nordisk A/S
• Treatments: Insulin; Liraglutide

Criteria

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 or equal to 80 years of age

• HbA1c greater than or equal to 7.5% (NGSP standard=DCCT standard)=58 mmol/mol (IFCC standard) and less than or equal to 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 0.10 nmol/l or greater (ref. 0.25-1.0 nmol/l)

• BMI greater than 27,5 kg/m2 and less than 45 kg/m2

Exclusion Criteria:

• Type 1 diabetes

• Fasting glucose less than 6.0 mmol/l or greater than 15.0 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, however, patients using systemic corticoid treatment only for substitution of cortisol deficiency (physiologic doses) such as Addisons Disease, do not need to be excluded

• Acute coronary syndrome, stroke, coronary artery intervention or myocardial infarction during the previous 6 months

• Creatinine greater than 150 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 14.6 pmol/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; accepted methods: oral contraceptive pills, depo provera contraceptive injections, implanted contraceptive, transdermal patch, intrauterine device, vasectomized partner, or abstinence.)

• 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

• Participation in another study