Clinical trial NCT02505334: A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus.
Official title: A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day 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: 2015-07-22
Enrollment: 635
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 aim of the trial is to compare the efficacy and safety of liraglutide 1.8 mg/day to liraglutide 0.9 mg/day in Japanese subjects with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Male or female Japanese subjects at least 20 years of age at the time of informed consent
* Type 2 diabetes subjects (diagnosed clinically) for at least 6 months prior to screening
* HbA1c 7.5-10.0% \[58 mmol/mol-86 mmol/mol\] (both inclusive)
* Subjects on stable therapy with one OAD (oral antidiabetic drug) (stable therapy is defined as unchanged medication and unchanged dose) for for at least 60 days before screening according to approved Japanese labelling

Exclusion Criteria:

* Treatment with insulin within 12 weeks prior to screening
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before screening
* Screening calcitonin equal or above 50 ng/l
* History of pancreatitis (acute or chronic)
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
* Subjects presently classified as being in New York Heart Association (NYHA) Class IV
* Within the past 180 days any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
* Diagnosis of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer, polyps and in-situ carcinomas)
* Any condition which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol

Primary outcomes:
measure: Change in Glycosylated Haemoglobin (HbA1c) (Week 26)
timeFrame: Week 0, Week 26
Secondary outcomes:
measure: Change in HbA1c (Week 52)
timeFrame: Week 0, Week 52
measure: Responder for HbA1c Below 7.0% (53 mmol/Mol)
timeFrame: Week 26 and Week 52
measure: Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)
timeFrame: Week 26 and Week 52
measure: Responder for HbA1c Below 7.0% Without Weight Gain
timeFrame: Week 26 and Week 52
measure: Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
timeFrame: Week 26 and Week 52
measure: Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
timeFrame: Week 0 and Week 26 and Week 52
measure: Change in SMBG 7-point Profile: Mean of 7-point Profile
timeFrame: Week 0, Week 26, Week 52
measure: Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)
timeFrame: Week 0, Week 26, Week 52
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: Week 0, Week 26, Week 52
measure: Change in Waist Circumference
timeFrame: Week 0, Week 26, Week 52
measure: Change in Body Weight
timeFrame: Week 0, Week 26, Week 52
measure: Change in Body Mass Index (BMI)
timeFrame: Week 0, Week 26, Week 52
measure: Change in Blood Pressure (Systolic and Diastolic)
timeFrame: Week 0, Week 26, Week 52
measure: Fasting C-peptide
timeFrame: Week 26 and Week 52
measure: Fasting Insulin
timeFrame: Week 26 and Week 52
measure: Fasting Glucagon
timeFrame: Week 26 and Week 52
measure: Proinsulin
timeFrame: Week 26 and Week 52
measure: Proinsulin/Insulin
timeFrame: Week 26 and Week 52
measure: Homeostasis Model Assessment of Beta-cell Function (HOMA-B)
timeFrame: Week 26 and Week 52
measure: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)
timeFrame: Week 26 and Week 52
measure: Total Cholesterol
timeFrame: Week 26 and Week 52
measure: Low Density Lipoprotein (LDL) Cholesterol
timeFrame: Week 26 and Week 52
measure: High Density Lipoprotein (HDL) Cholesterol
timeFrame: Week 26 and Week 52
measure: Very Low Density Lipoprotein (VLDL) Cholesterol
timeFrame: Week 26 and Week 52
measure: Triglycerides
timeFrame: Week 26 and Week 52
measure: Free Fatty Acids
timeFrame: Week 26 and Week 52
measure: Number of Treatment Emergent Adverse Events
timeFrame: Weeks 0-26 and Weeks 0-52
measure: Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
timeFrame: Weeks 0-26 and Weeks 0-52
measure: Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
timeFrame: Weeks 0-26 and Weeks 0-52
measure: Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
timeFrame: Weeks 0-26 and Weeks 0-52
measure: Change in Pulse
timeFrame: Week 0, Week 26, Week 52
measure: Change in Physical Examination
timeFrame: Week 0 and Week 26 and Week 52
measure: Change in Eye Examination
timeFrame: Week 0 and Week 26 and Week 52
measure: Change in Electrocardiogram (ECG)
timeFrame: Week 0 and Week 26 and Week 52
measure: Change in Biochemistry: Creatinine
timeFrame: Week 0, Week 26, Week 52
measure: Change in Biochemistry: eGFR
timeFrame: Week 0, Week 26, Week 52
measure: Change in Biochemistry: Alanine Aminotransferase
timeFrame: Week 0, Week 26, Week 52
measure: Change in Biochemistry: Aspartate Aminotransferase
timeFrame: Week 0, Week 26, Week 52
measure: Change in Biochemistry: Alkaline Phosphatase
timeFrame: Week 0, Week 26, Week 52
measure: Change in Biochemistry: Sodium
timeFrame: Week 0, Week 26, Week 52
measure: Change in Biochemistry: Potassium
timeFrame: Week 0, Week 26, Week 52
measure: Change in Biochemistry: Albumin
timeFrame: Week 0, Week 26, Week 52
measure: Change in Biochemistry: Total Bilirubin
timeFrame: Week 0, Week 26, Week 52
measure: Change in Biochemistry: Urea
timeFrame: Week 0, Week 26, Week 52
measure: Change in Biochemistry: Creatine Kinase
timeFrame: Week 0, Week 26, Week 52
measure: Change in Biochemistry: Calcium
timeFrame: Week 0, Week 26, Week 52
measure: Change in Biochemistry: Albumin Corrected Calcium
timeFrame: Week 0, Week 26, Week 52
measure: Change in Biochemistry: Amylase
timeFrame: Week 0, Week 26, Week 52
measure: Change in Biochemistry: Lipase
timeFrame: Week 0, Week 26, Week 52
measure: Change in Haematology: Haemoglobin
timeFrame: Week 0, Week 26, Week 52
measure: Change in Haematology: Haematocrit
timeFrame: Week 0, Week 26, Week 52
measure: Change in Haematology: Thrombocytes
timeFrame: Week 0, Week 26 and Week 52
measure: Change in Haematology: Erythrocytes
timeFrame: Week 0, Week 26 and Week 52
measure: Change in Haematology: Leukocytes
timeFrame: Week 0, Week 26 and Week 52
measure: Change in Haematology: Eosinophils
timeFrame: Week 0, Week 26 and Week 52
measure: Change in Haematology: Neutrophils
timeFrame: Week 0, Week 26 and Week 52
measure: Change in Haematology: Basophils
timeFrame: Week 0, Week 26 and Week 52
measure: Change in Haematology: Monocytes
timeFrame: Week 0, Week 26 and Week 52
measure: Change in Haematology: Lymphocytes
timeFrame: Week 0, Week 26 and Week 52
measure: Change in Calcitonin
timeFrame: Week 0 and Week 26 and Week 52
Other outcomes:
Locations:
city: Annaka-shi, Gunma
country: Japan
facility: Novo Nordisk Investigational Site
city: Chitose, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Chuo-ku Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Chuo-ku,
country: Japan
facility: Novo Nordisk Investigational Site
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Higashiosaka-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Ichikawa-shi, Chiba
country: Japan
facility: Novo Nordisk Investigational Site
city: Iruma-shi, Saitama
country: Japan
facility: Novo Nordisk Investigational Site
city: Izumisano-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Kashiwara-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Kawagoe-shi, Saitama
country: Japan
facility: Novo Nordisk Investigational Site
city: Kobe-shi, Hyogo
country: Japan
facility: Novo Nordisk Investigational Site
city: Kumamoto-shi,Kumamoto
country: Japan
facility: Novo Nordisk Investigational Site
city: Mito-shi, Ibaraki
country: Japan
facility: Novo Nordisk Investigational Site
city: Mito-shi, Ibaraki
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: Neyagawa-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Nishinomiya-shi, Hygo
country: Japan
facility: Novo Nordisk Investigational Site
city: Nishinomiya-shi, Hyogo
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: Osaka-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Oyama-shi, Tochigi
country: Japan
facility: Novo Nordisk Investigational Site
city: Saga-shi,Saga
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: Sapporo-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Sappro-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Shimotsuke-shi, Tochigi
country: Japan
facility: Novo Nordisk Investigational Site
city: Shinjuku-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Shizuoka-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Suita-shi, Osaka
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: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Yokohama, Kanagawa
country: Japan
facility: Novo Nordisk Investigational Site
city: Yokohama-shi Kanagawa
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: Clinical Reporting Anchor and Disclosure 1452
role: STUDY_DIRECTOR
References: