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.

• Status: Completed
• Trial end date: 2017-11-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Liraglutide

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