Phase 3 · Liraglutide

DUAL I Japan trial results

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

Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs Lira (Percentage of HbA1c), Week 0, Week 52. Insulin Degludec/Liraglutide: -2.42; Insulin Degludec: -1.80; Liraglutide: -1.80.

Participants
819
Status
completed
Completed
2017-12-22
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT02607306), 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 I Japan measured first

Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs LiraPercentage of HbA1c · Week 0, Week 52 · mean
Insulin Degludec/Liraglutiden=275Insulin Degludecn=271Liraglutiden=273
-2.42(1.04)-1.80(1.02)-1.80(0.92)
Side effects by arm

Side effects in DUAL I Japan

Percent of participants affected, Week 0 (randomisation) to week 52 (end of treatment) and 7 days after end of treatment.. The most common events the registry lists.

EventInsulin Degludec/LiraglutideInsulin DegludecLiraglutide
Any serious event6.2%4.8%5.1%
Viral upper respiratory tract infection38.5%33.6%34.4%
Constipation9.8%4.4%13.9%
Diarrhoea5.5%4.4%8.8%
Nausea3.3%1.8%8.4%
Weight increased1.5%7%0.4%
Diabetic retinopathy6.2%4.4%4%
Eczema5.8%2.2%3.3%
Headache2.5%2.6%5.5%
Influenza5.5%3.3%3.3%
Lipase increased2.2%0%5.5%
Pharyngitis4%5.5%3.3%
Secondary outcomes

What else it measured

Change From Baseline in Body Weight (kg)Kg · Week 0, Week 52 · mean
Insulin Degludec/Liraglutiden=275Insulin Degludecn=271Liraglutiden=273
2.9(3.2)4.1(4.3)-1.0(3.4)
Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic EpisodesEpisodes · Weeks 0-52 · number
Insulin Degludec/Liraglutiden=275Insulin Degludecn=271Liraglutiden=273
46786913
Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Superiority of IDegLira vs IDegPercentage of HbA1c · Week 0, Week 52 · mean
Insulin Degludec/Liraglutiden=275Insulin Degludecn=271Liraglutiden=273
-2.42(1.04)-1.80(1.02)-1.80(0.92)
Change From Baseline in Fasting Plasma Glucose (FPG)mmol/L · Week 0, Week 52 · mean
Insulin Degludec/Liraglutiden=275Insulin Degludecn=271Liraglutiden=272
-4.08(2.47)-3.97(2.56)-2.62(1.95)
Insulin DoseInsulin Units/Day · After 52 weeks of treatment · mean
Insulin Degludec/Liraglutiden=275Insulin Degludecn=271
27.7(14.8)34.8(26.0)
Responder (Yes/no): HbA1c Less Than 7.0%Participants · After 52 weeks of treatment · count of participants
MeasureInsulin Degludec/Liraglutiden=275Insulin Degludecn=271Liraglutiden=273
Yes245189208
No308265
Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to ZeroParticipants · After 52 weeks of treatment · count of participants
MeasureInsulin Degludec/Liraglutiden=275Insulin Degludecn=271Liraglutiden=273
Yes4422142
No231249131
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 Treatment.Participants · After 52 weeks of treatment · count of participants
MeasureInsulin Degludec/Liraglutiden=270Insulin Degludecn=265Liraglutiden=271
Yes227169206
No439665
Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of TreatmentParticipants · After 52 weeks of treatment · count of participants
MeasureInsulin Degludec/Liraglutiden=270Insulin Degludecn=265Liraglutiden=271
Yes3722141
No233243130
Responder (Yes/no): HbA1c Less Than 6.5%Participants · After 52 weeks of treatment · count of participants
MeasureInsulin Degludec/Liraglutiden=275Insulin Degludecn=271Liraglutiden=273
Yes213134171
No62137102
Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to ZeroParticipants · After 52 weeks of treatment · count of participants
MeasureInsulin Degludec/Liraglutiden=275Insulin Degludecn=271Liraglutiden=273
Yes4117126
No234254147
Responder (Yes/no): HbA1c Less Than 6.5% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.Participants · After 52 weeks of treatment · count of participants
MeasureInsulin Degludec/Liraglutiden=270Insulin Degludecn=265Liraglutiden=271
Yes198123170
No72142101
The trial

How DUAL I 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, insulin degludec and liraglutide in Japanese subjects with type 2 diabetes mellitus.

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

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

Published papers

Papers from DUAL I 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.