The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes (ADJUNCT ONE™)

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

NCT01836523

U1111-1133-0590 (Other Identifier)

2012-003580-21 (EudraCT Number)

NN9211-3919

Details and patient eligibility

About

This trial is conducted globally. The aim of the trial is to confirm the efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. The total trial duration per subject is approximately 58 weeks.

Enrollment: 1,398 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Informed consent obtained
• • Type 1 diabetes mellitus for 12 months or longer
• • Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump) treatment for 6 months or longer
• • Stable insulin treatment for the last 3 months prior to Screening, as judged and documented by the investigator
• • HbA1c 7.0-10% (Diabetes Control and Complications Trial (DCCT)), both inclusive, (corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC))
• • Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, complete trial related questionnaires, diaries, self-monitoring of plasma glucose, self titration of insulin and attend all scheduled visits

Exclusion criteria

• • Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPP-4) inhibitors
• • Use of any medication, which in the investigator's opinion could interfere with the glycaemic control 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 above 160 mmHg for systolic or above 100 mmHg for diastolic
• • History of acute or chronic pancreatitis
• • Screening calcitonin value equal to or above 50 ng/L
• • Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2 (MEN2)
• • Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,398 participants in 6 patient groups, including a placebo group

Liraglutide 0.6 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 1.8 mg + insulin

Experimental group

Treatment:

Drug: liraglutide

Drug: liraglutide

Drug: liraglutide

Liraglutide placebo 0.6 mg + insulin

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

Liraglutide placebo 1.2 mg + insulin

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

Liraglutide placebo 1.8 mg + insulin

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo