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.

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02505334

NN2211-4174

JapicCTI-152975 (Registry Identifier)

U1111-1164-5462 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 635 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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635 participants in 2 patient groups

Liraglutide 1.8 mg

Experimental group

Description:

The total trial duration for the 1.8 mg/day treatment arm will be approximately 67 weeks, consisting of 2 weeks screening period, a 12 weeks run-in period, a 26-week main treatment period, a safety extension period of 26 weeks and a follow-up visit.

Treatment:

Drug: liraglutide

Liraglutide 0.9 mg

Active Comparator group

Description:

The total trial duration for the 0.9 mg/day treatment arm will be approximately 41 weeks, consisting of 2 weeks screening period, a 12 weeks run-in period, a 26-week treatment period, and a follow-up visit.

Treatment:

Drug: liraglutide