The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes (ADJUNCT TWO™)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: liraglutide; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02098395

NL47705.060.14 (Registry Identifier)

2012-005778-74 (EudraCT Number)

REec-2014-0884 (Registry Identifier)

U1111-1138-0619 (Other Identifier)

NN9211-4083

Details and patient eligibility

About

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.

Enrollment: 835 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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835 participants in 6 patient groups, including a placebo group

Liraglutide 1.8 mg + insulin

Experimental group

Treatment:

Drug: liraglutide

Drug: liraglutide

Drug: liraglutide

Liraglutide 1.2 mg + insulin

Experimental group

Treatment:

Drug: liraglutide

Drug: liraglutide

Drug: liraglutide

Liraglutide 0.6 mg + insulin

Experimental group

Treatment:

Drug: liraglutide

Drug: liraglutide

Drug: liraglutide

Liraglutide placebo 0.3 ml + insulin

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

Liraglutide placebo 0.2 ml + insulin

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

Liraglutide placebo 0.1 ml + insulin

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo