Clinical trial NCT01572740: Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Alone in Japanese Subjects With Type 2 Diabetes
Official title: A 36-week, Randomised, Multi-centre, Double-blind, Parallel Group Trial to Investigate the Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Monotherapy in Japanese Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-04-06
Enrollment: 257
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16
timeFrame: Week 0, Week 16
Secondary outcomes:
measure: Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36
timeFrame: Week 0, Week 36
measure: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16
timeFrame: Week 0, Week 16
measure: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36
timeFrame: Week 0, Week 36
measure: Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16
timeFrame: Week 0, Week 16
measure: Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36
timeFrame: Week 0, Week 36
measure: Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 16
timeFrame: Week 0, Week 16
measure: Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 36
timeFrame: Week 0, Week 36
measure: Change in Body Weight From Baseline to Week 16
timeFrame: Week 0, Week 16
measure: Change in Body Weight From Baseline to Week 36
timeFrame: Week 0, Week 36
measure: Number of Adverse Events (AEs)
timeFrame: Week 0 to Week 36 (inclusive)
measure: Number of Confirmed Hypoglycaemic Episodes
timeFrame: Week 0 to week 36 (inclusive)
Other outcomes:
Locations:
city: Chuo-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Ebina-shi, Kanagawa
country: Japan
facility: Novo Nordisk Investigational Site
city: Ebina-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Kashiwara-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Katsushika-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Koriyama-shi, Fukushima
country: Japan
facility: Novo Nordisk Investigational Site
city: Miyazaki-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Naka-shi, Ibaraki
country: Japan
facility: Novo Nordisk Investigational Site
city: Niigata-shi, Niigata
country: Japan
facility: Novo Nordisk Investigational Site
city: Nishinomiya-shi, Hygo
country: Japan
facility: Novo Nordisk Investigational Site
city: Oita-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Okawa-shi, Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Osaka-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Ota-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Oyama-shi, Tochigi
country: Japan
facility: Novo Nordisk Investigational Site
city: Sapporo-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Sapporo-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Sendai-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Shimotsuke-shi, Tochigi
country: Japan
facility: Novo Nordisk Investigational Site
city: Shizuoka-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Takatsuki-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Yokohama-shi
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Seino Y, Kaneko S, Fukuda S, Osonoi T, Shiraiwa T, Nishijima K, Bosch-Traberg H, Kaku K. Combination therapy with liraglutide and insulin in Japanese patients with type 2 diabetes: A 36-week, randomized, double-blind, parallel-group trial. J Diabetes Investig. 2016 Jul;7(4):565-73. doi: 10.1111/jdi.12457. Epub 2016 Jan 23.
citation: Kaneko S, Nishijima K, Bosch-Traberg H, Kaku K, Seino Y. Efficacy and safety of adding liraglutide to existing insulin regimens in Japanese patients with type 2 diabetes mellitus: A post-hoc analysis of a phase 3 randomized clinical trial. J Diabetes Investig. 2018 Jul;9(4):840-849. doi: 10.1111/jdi.12793. Epub 2018 Feb 5.