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

Novo Nordisk A/S257 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

257

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

liraglutideDRUG

Liraglutide administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.

placeboDRUG

Liraglutide placebo administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.

insulinDRUG

All subjects will continue their pre-trial insulin therapy (basal, premixed or basal-bolus regimen) during the trial. Insulin dose is fixed for the first 16 weeks and for the subsequent 20 weeks, insulin dose is individually adjusted.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (23)

Novo Nordisk Investigational Site

Chuo-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16

Estimated mean change from baseline in HbA1c after 16 Weeks of treatment.

Time frame: Week 0, Week 16

Secondary Outcomes

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36

Estimated mean change from baseline in HbA1c after 36 Weeks of treatment

Time frame: Week 0, Week 36

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16

Estimated mean change from baseline in FPG after 16 Weeks of treatment.

Time frame: Week 0, Week 16

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36

Estimated mean change from baseline in FPG after 36 Weeks of treatment.

Time frame: Week 0, Week 36

Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16

Estimated mean change from baseline in mean PG of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 16 Weeks of treatment.

Time frame: Week 0, Week 16

Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36

Time frame: Week 0, Week 36

Data from ClinicalTrials.gov

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