Phase 3 · Liraglutide

DUAL II Japan trial results

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

Change in Glycosylated Haemoglobin (HbA1c) (Percentage of HbA1c), week 0, week 26. Insulin Degludec/Liraglutide: -1.95; Insulin Degludec: -0.65.

Participants
210
Status
completed
Completed
2017-11-22
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT02911948), updated at source Apr 9, 2021. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What DUAL II Japan measured first

Change in Glycosylated Haemoglobin (HbA1c)Percentage of HbA1c · week 0, week 26 · mean
Insulin Degludec/Liraglutiden=105Insulin Degludecn=105
-1.95(1.01)-0.65(0.98)
Side effects by arm

Side effects in DUAL II Japan

Percent of participants affected, Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment.. The most common events the registry lists.

EventInsulin Degludec/LiraglutideInsulin Degludec
Any serious event2.9%3.8%
Viral upper respiratory tract infection20%22.9%
Diabetic retinopathy16.2%16.2%
Diarrhoea14.3%4.8%
Nausea9.5%3.8%
Constipation8.6%3.8%
Vomiting8.6%1.9%
Abdominal discomfort7.6%4.8%
Decreased appetite7.6%0%
Secondary outcomes

What else it measured

Change in Body WeightKg · week 0, week 26 · mean
Insulin Degludec/Liraglutiden=105Insulin Degludecn=105
-0.7(3.5)0.7(2.7)
Change in Fasting Plasma Glucose (FPG)mmol/L · week 0, week 26 · mean
Insulin Degludec/Liraglutiden=105Insulin Degludecn=105
-2.81(3.17)-2.29(2.68)
Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic EpisodesNumber of episodes · During 26 weeks of treatment · number
Insulin Degludec/Liraglutiden=105Insulin Degludecn=105
124109
Daily Insulin DoseUnits · After 26 weeks · mean
Insulin Degludec/Liraglutiden=105Insulin Degludecn=105
37.6(11.4)41.2(11.5)
Responder (Yes/no): HbA1c Less Than 7.0%Participants · After 26 weeks · count of participants
MeasureInsulin Degludec/Liraglutiden=105Insulin Degludecn=105
Yes7523
No3082
Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight GainParticipants · After 26 weeks · count of participants
MeasureInsulin Degludec/Liraglutiden=105Insulin Degludecn=105
Yes509
No5596
Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of TreatmentParticipants · After 26 weeks · count of participants
MeasureInsulin Degludec/Liraglutiden=105Insulin Degludecn=101
Yes7020
No3581
Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight Gain and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of TreatmentParticipants · After 26 weeks · count of participants
MeasureInsulin Degludec/Liraglutiden=105Insulin Degludecn=101
Yes497
No5694
Responder (Yes/no): HbA1c Less Than or Equal to 6.5%Participants · After 26 weeks · count of participants
MeasureInsulin Degludec/Liraglutiden=105Insulin Degludecn=105
Yes579
No4896
Responder (Yes/no): HbA1c Less Than or Equal to 6.5% and Without Weight GainParticipants · After 26 weeks · count of participants
MeasureInsulin Degludec/Liraglutiden=105Insulin Degludecn=105
Yes384
No67101
Responder (Yes/no): HbA1c Less Than or Equal to 6.5% Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of TreatmentParticipants · After 26 weeks · count of participants
MeasureInsulin Degludec/Liraglutiden=105Insulin Degludecn=101
Yes538
No5293
Responder (Yes/no): HbA1c Less Than or Equal to 6.5% and Without Weight Gain and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of TreatmentParticipants · After 26 weeks · count of participants
MeasureInsulin Degludec/Liraglutiden=105Insulin Degludecn=101
Yes373
No6898
The trial

How DUAL II Japan was run

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.

  • Insulin degludec/liraglutide
  • Insulin degludec
Who could join the trial

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Published papers

Papers from DUAL II Japan

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.