iraglutide in type 1 diabetes. A randomised, double-blind, placebo controlled study of the effect of liraglutide as an additional treatment to insulin on HbA1c, body weight and hypoglycaemia in poorly regulated type 1 diabetes patients.

Phase 1

Conditions: Primary objective:To investigate the effect of liraglutide 1.8 mg once daily compared to placebo for 24 weeks on change in HbA1c in patients with type 1 diabetes as an add-on therapy to insulin.Secondary objectives:To investigate the effect of liraglutide as an add-on therapy to insulin compared to placebo on change in:Weight, insulin dose,hypoglycaemic events, CGM, BMI, body composition, quality of life, treatment satisfaction,food preferences, meal test, CIMT, PWV and 24 hour blood pressure.
MedDRA version: 14.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2012-001150-26-DK

Lead Sponsor: Steno Diabetes Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

• Type 1 diabetes according to WHO criteria = 1 year
• Age = 18 years
• BMI > 25 kg/m2
• HbA1c > 8.0 % at visit 0
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

• Insulin pump treatment
• Hypoglycaemia unawareness (unability to register low blood glucose)
• Diabetic gastroparesis
• Compromised kidney function (eGFR < 60 ml/min/1,73m2), dialysis or kidney transplantation at visit 0
• Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
• Acute or chronic pancreatitis
• Inflammatory bowel disease
• Cancer unless in complete remission for > 5 years
• History of thyroid adenoma or carcinoma
• Alcohol/drug abuse
• Fertile women not using contraceptives
• Pregnant or nursing women
• Simultaneous participation in any other clinical intervention trial

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of liraglutide 1.8 mg once daily compared to placebo for 24 weeks on change in HbA1c in patients with type 1 diabetes as an adjunctive therapy to insulin treatment.<br>;Secondary Objective: To investigate the effect of liraglutide as an adjunctive therapy to insulin treatment compared to placebo on change in: Weight, insulin dose, hypoglycaemic events, glycaemic excursions (time spent in hypo- and hyperglycaemia as measured by CGM), BMI, body composition, quality of life and treatment satisfaction, food preferences, VAS score for appetite, standardised liquid meal test for postprandial glucagon levels and glycaemic excursions, gastric emptying via serum paracetamol measurements, CIMT, PWV and 24 hour blood pressure.;Primary end point(s): Change in HbA1c from visit 1 to the end of treatment after 24 weeks of intervention. ;Timepoint(s) of evaluation of this end point: At the end of treatment after 24 weeks of intervention.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Changes from visit 1 to the end of treatment after 24 weeks of intervention in:<br>• Weight <br>• Insulin dose<br>• Hypoglycaemic events<br>• Glycaemic excursions (time spent in hypo- and hyperglycaemia as measured by CGM)<br>• BMI<br>• Lean body mass and fat mass composition as determined by Dual-Energy X-ray absorptiometry (DXA) scan<br>• Quality of life and treatment satisfaction<br>• Food preferences<br>• VAS score for appetite<br>• Standardised liquid mixed meal test for postprandial glucagon levels and glycaemic excursion<br>• Gastric emptying via serum paracetamol measurements <br>• Carotis intima media thickness<br>• Pulse wave velocity<br>• 24 hour blood pressure and pulse rate;Timepoint(s) of evaluation of this end point: At the end of treatment after 24 weeks of intervention.