A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus.

• Status: Completed
• Trial end date: 2017-12-22
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide, insulin degludec and liraglutide in Japanese subjects with type 2 diabetes mellitus.

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

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin, Globin Zinc; Insulin, Long-Acting; Liraglutide; Xultophy

Criteria

Inclusion Criteria:

• Male or female Japanese subjects, age at least 20 years at the time of signing informed consent

• Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening

• HbA1c (glycosylated haemoglobin) 7.0-11.0 % (both inclusive) by central laboratory analysis, with the aim of a median of 8.3%. When approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c below or equal to 8.3%; or when approximately 50% of the randomised subjects have a HbA1c below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3%

• Body-mass index (BMI) above or equal to 20 kg/m^2

• Subjects on stable therapy with one OAD (defined as unchanged medication and unchanged dose) for at least 60 days (metformin, a-GI, TZD, SU, SGLT2i or glinide) prior to screening according to approved Japanese labelling

Exclusion Criteria:

• Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness including gestational diabetes)

• 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

• Anticipated initiation or change in concomitant medications in excess of 14 days known to affect weight or glucose metabolism

• Impaired liver function, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or above 2.5 times upper limit of normal

• Renal impairment estimated Glomerular Filtration Rate (eGFR) below 60mL/min/1.73m^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)

• Screening calcitonin equal to 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