A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus. (DUAL™ I Japan)

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: insulin degludec

Drug: insulin degludec/liraglutide

Drug: liraglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT02607306

NN9068-4183

U1111-1170-1332 (Other Identifier)

JapicCTI-153089 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

819 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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