NCT02911948|CompletedPhase 3Results

A Double-blinded Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec Both in Combination With Metformin in Japanese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal or Pre-mix/Combination Insulin Therapy and Oral Anti-diabetic Drugs

DUAL™ II Japan

Novo Nordisk A/S ClinicalTrials.gov

Compare

3 other identifiers

NN9068-4184U1111-1178-3453JapicCTI-163385

Study Type

interventional

Target

210

Locations

1 country

Sites

Timeline

RegisteredSep 2016

StartedSep 2016

CompletionNov 2017

Brief Summary

This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide and insulin degludec both in combination with metformin in Japanese subjects with type 2 diabetes mellitus inadequately controlled with basal or pre-mix/combination insulin therapy and oral anti-diabetic drugs.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

210

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Sep 2016

Geographic Reach

1 country

38 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

First Submitted

Initial submission to the registry

September 20, 2016

Completed

1 day until next milestone

Study Start

First participant enrolled

September 21, 2016

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2017

Completed

5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2017

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

March 11, 2019

Completed

Last Updated

April 9, 2021

Status Verified

March 1, 2021

Enrollment Period

1.2 years

First QC Date

September 20, 2016

Results QC Date

November 13, 2018

Last Update Submit

March 10, 2021

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in Glycosylated Haemoglobin (HbA1c)
Change from baseline (week 0) in HbA1c after 26 weeks of treatment.
week 0, week 26

Secondary Outcomes (27)

Change in Body Weight
week 0, week 26
Change in Fasting Plasma Glucose (FPG)
week 0, week 26
Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes
During 26 weeks of treatment
Daily Insulin Dose
After 26 weeks
Responder (Yes/no): HbA1c Less Than 7.0%
After 26 weeks
+22 more secondary outcomes

Study Arms (2)

Insulin degludec/liraglutide

EXPERIMENTAL

Drug: Insulin degludec/liraglutide

Insulin degludec

ACTIVE COMPARATOR

Drug: Insulin degludec

Interventions

Insulin degludec/liraglutideDRUG

Injected s.c. / subcutaneously (under the skin) once daily

Insulin degludec/liraglutide

Insulin degludecDRUG

Injected s.c. / subcutaneously (under the skin) once daily

Insulin degludec

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female Japanese subjects, age at least 20 years at the time of signing informed consent
T2DM (type 2 diabetes mellitus) subjects (diagnosed clinically) for at least 6 months prior to screening
HbA1c (glycosylated haemoglobin) 7.5-11.0 per cent \[58 mmol/mol-97 mmol/mol\] (both inclusive) by central laboratory analysis
Subjects on stable daily insulin doses for at least 60 days prior to screening administered once or twice daily, either as basal insulin (e.g. IDeg, insulin glargine, insulin detemir, NPH insulin) or pre-mix/combination insulin (e.g. biphasic insulin aspart, insulin degludec/insulin aspart). Total daily insulin dose in the previous 60 days should be within 20-50 units, both inclusive, and on the day of screening, but fluctuations of plus/minus 20 per cent within the 60 days prior to screening are acceptable. The specified insulin treatment should be administered in combination with a stable daily dose of metformin within current approved Japanese label for at least 60 days prior to screening - additionally, the anti-diabetic treatment can be with or without a stable daily dose of one of the following other OADs (oral anti-diabetic drug): SU (sulfonylureas), glinides, alpha-glucosidase inhibitor, SGLT2i (sodium glucose co-transporter 2 inhibitor) or TZD (thiazolidinedione) within current approved Japanese label for at least 60 days prior to screening
Body Mass Index (BMI) equal or above 23 kg/m\^2

You may not qualify if:

Receipt of any investigational medicinal product (IMP) within 30 days before screening
Use of any anti-diabetic drug in a period of 60 days before screening (except premix/ combination or basal insulin, metformin, SU, glinides, α-GI, SGLT2i, or TZD) or anticipated change in concomitant medication, which in the investigators opinion could interfere with glucose metabolism (e.g. systemic corticosteroids or bolus insulin)
Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist during the last 60 days prior to screening and furthermore, the discontinuation of GLP-1 receptor agonist at any point in time must not have been due to safety concerns, tolerability issues or lack of efficacy, as judged by the investigator
Treatment with dipetidyl peptidase-4 (DPP-4) inhibitors during the last 60 days prior to screening - Impaired liver function, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal or above 2.5 times upper limit of normal
Renal impairment estimated Glomerular Filtration Rate (eGFR) below 60 mL/min/1.73m\^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
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

Contact the study team to confirm eligibility.