The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes

Phase 3

Completed

Brief Summary: This trial is conducted in Africa, Europe and North America. The purpose of the trial is to investigate the efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes.

Recruitment & Eligibility

Inclusion Criteria

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Male or female, aged equal to or greater than 18 years at the time of signing informed consent
Type 1 diabetes mellitus (as diagnosed clinically) 12 months or longer prior to Visit 1 (i.e. screening)
Treatment with basal bolus or CSII (continuous subcutaneous insulin infusion, insulin pump) treatment 6 months or longer prior to Visit 1 (i.e. screening)
Stable insulin treatment 3 months or longer prior to Visit 1 (i.e. screening), as judged and documented by the investigator
HbA1c 7.0-10.0 percent (Diabetes Control and Complications Trial (DCCT)), both inclusive, by central laboratory analysis (Visit 1, screening) corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC))

Exclusion Criteria

Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPPIV) inhibitors
Use of any medication, which in the investigator's opinion could interfere with the glycaemic control (e.g. systemic corticosteroids, pramlintide (Symlin®)) 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 (Visit 1) (after resting for 5 minutes) while sitting greater than 160 mmHg for systolic or greater than 100 mmHg for diastolic (repeated measurement at Visit 2 (prior to performing the trial related activities) is allowed to exclude white-coat hypertension)
History of acute or chronic pancreatitis
Screening (Visit 1) calcitonin value equal to or greater than 50 ng/L

Arm && Interventions

Group	Intervention	Description
Liraglutide placebo 0.3 ml + insulin	placebo	-
Liraglutide 1.8 mg + insulin	liraglutide	-
Liraglutide 1.2 mg + insulin	liraglutide	-
Liraglutide placebo 0.2 ml + insulin	placebo	-
Liraglutide placebo 0.1 ml + insulin	placebo	-
Liraglutide 0.6 mg + insulin	liraglutide	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Glycosylated Haemoglobin (HbA1c)	Week 0, Week 26	Change from baseline in glycosylated haemoglobin (HbA1c), after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Body Weight	Week 0, Week 26	Change from baseline body weight, after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.
Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes	Weeks 0-26	Number of treatment-emergent symptomatic hypoglycaemic episodes during 26 weeks of treatment. Symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or a self-measured plasma glucose (SMPG) value of \<3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification is defined as an episode that required assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.