Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Alone in Japanese Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin; Drug: liraglutide; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01572740

JapicCTI-121802 (Other Identifier)

U1111-1122-4320 (Other Identifier)

NN2211-3925

Details and patient eligibility

About

This trial is conducted in Asia. The purpose of the trial is to investigate the efficacy and safety of liraglutide in combination with insulin therapy compared to insulin alone in Japanese subjects with type 2 diabetes mellitus. Subjects will remain on their pre-trial insulin therapy.

Enrollment: 257 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
• Current insulin therapy (basal insulin, premixed insulin or basal-bolus regimen) in addition to diet and exercise therapy for at least 12 weeks prior to trial start. Their therapy is stable and fluctuation of total daily insulin dose is within plus/minus 20% for at least 12 weeks prior to trial start and current total daily insulin dose equal to or greater than 10 (I)U/day
• Glycosylated haemoglobin (HbA1c) between 7.5 and 11.0% (both inclusive)
• Body Mass Index (BMI) below 45.0 kg/m^2

Exclusion criteria

• Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as, but not limited to systemic corticosteroids, beta-antagonists or monoamine oxidase (MAO) inhibitors
• Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode during last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
• Known proliferative retinopathy or maculopathy requiring treatment according to the investigator
• Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist within 12 weeks prior to screening
• Treatment with any oral antidiabetic drugs (OADs) within 12 weeks prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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257 participants in 2 patient groups, including a placebo group

Lira+Insulin

Experimental group

Treatment:

Drug: insulin

Drug: liraglutide

Placebo+Insulin

Placebo Comparator group

Treatment:

Drug: insulin

Drug: placebo