← Trials/Trial dossier/NCT02911948

DUAL™ II Japan

CompletedPhase 3Results posted

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

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

210

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥23•HbA1c 7.5-11%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02911948

Org study IDNN9068-4184

Secondary IDJapicCTI-163385JapicCTI

Secondary IDU1111-1178-3453WHO

Timeline

Milestones

Study start2016-09-21actual

Study first posted2016-09-23estimated

Primary completion2017-11-17actual

Study completion2017-11-22actual

Results first posted2019-03-11actual

Last update posted2021-04-09actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (56)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Safety / tolerability / PK

Cardiometabolic biomarkers

Weight & body composition

Patient-reported / QoL

Other clinical outcomes

Other (unclassified)

Weight & body composition

4 endpoints

Secondary/registry result

Change in Body Weight

Time frame:week 0, week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kg	95% CI
Insulin Degludec/Liraglutide	-0.7	—
Insulin Degludec	0.7	—

Secondary/registry result

Change in Waist Circumference

Time frame:week 0, week 26

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), cm	95% CI
Insulin Degludec/Liraglutide	-0.6	—
Insulin Degludec	0.1	—

Secondary/protocol endpoint

Change in Body Weight

Time frame:week 0, week 26

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:week 0, week 26

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

27 endpoints

Primary/registry result

Change in Glycosylated Haemoglobin (HbA1c)

Time frame:week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Insulin Degludec/Liraglutide	-1.95	—
Insulin Degludec	-0.65	—

Treatment contrast-1.2895% CI-1.50 – -1.06p<0.0001ANCOVA

Primary/protocol endpoint

Change in Glycosylated Haemoglobin (HbA1c)

Time frame:week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change in Fasting Plasma Glucose (FPG)

Time frame:week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
Insulin Degludec/Liraglutide	-2.81	—
Insulin Degludec	-2.29	—

Secondary/registry result

Daily Insulin Dose

Time frame:After 26 weeks

change from baseline, improvement

Posted result

Group	Value (mean), Units	95% CI
Insulin Degludec/Liraglutide	37.6	—
Insulin Degludec	41.2	—

Secondary/registry result

Responder (Yes/no): HbA1c Less Than 7.0%

Time frame:After 26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideYes	75	—
No	30	—
Insulin DegludecYes	23	—
No	82	—

Secondary/registry result

Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight Gain

Time frame:After 26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideYes	50	—
No	55	—
Insulin DegludecYes	9	—
No	96	—

Secondary/registry result

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

Time frame:After 26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Severe hypoglycemia, Documented hypoglycemia

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideYes	70	—
No	35	—
Insulin DegludecYes	20	—
No	81	—

Secondary/registry result

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 Treatment

Time frame:After 26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Severe hypoglycemia, Documented hypoglycemia

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideYes	49	—
No	56	—
Insulin DegludecYes	7	—
No	94	—

Secondary/registry result

Responder (Yes/no): HbA1c Less Than or Equal to 6.5%

Time frame:After 26 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideYes	57	—
No	48	—
Insulin DegludecYes	9	—
No	96	—

Secondary/registry result

Responder (Yes/no): HbA1c Less Than or Equal to 6.5% and Without Weight Gain

Time frame:After 26 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

componentsHbA1c <6.5% achievement, Body weight, absolute change (kg)

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideYes	38	—
No	67	—
Insulin DegludecYes	4	—
No	101	—

Secondary/registry result

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 Treatment

Time frame:After 26 weeks

Expanded / custom MACE composite

threshold achievement, improvement

componentsHbA1c <6.5% achievement, Severe hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideYes	53	—
No	52	—
Insulin DegludecYes	8	—
No	93	—

Secondary/registry result

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 Treatment

Time frame:After 26 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

componentsHbA1c <6.5% achievement, Body weight, absolute change (kg), Severe hypoglycemia, Documented hypoglycemia

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideYes	37	—
No	68	—
Insulin DegludecYes	3	—
No	98	—

Secondary/registry result

Self-measured Blood Glucose (SMBG) 9-point Profile (Individual Points in the Profile)

Time frame:After 26 weeks

Postprandial glucose

descriptive

Posted result

Group	Value (mean), mmol/L	95% CI
Insulin Degludec/LiraglutideBefore breakfast	6.59	—
90 minutes after start of breakfast	11.00	—
Before lunch	7.22	—
90 minutes after start of lunch	10.59	—
Before dinner	7.39	—
90 minutes after start of dinner	11.09	—
At Bedtime	9.57	—
At 4:00 a.m.	6.75	—
Before breakfast the following day	6.14	—
Insulin DegludecBefore breakfast	6.53	—
90 minutes after start of breakfast	12.02	—
Before lunch	8.49	—
90 minutes after start of lunch	12.84	—
Before dinner	8.60	—
90 minutes after start of dinner	13.27	—
At Bedtime	11.98	—
At 4:00 a.m.	7.72	—
Before breakfast the following day	6.40	—

Secondary/registry result

Change in SMBG 9-point Profile: Mean of the 9-point Profile

Time frame:Week 0, week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Insulin Degludec/Liraglutide	-2.90	—
Insulin Degludec	-1.11	—

Secondary/registry result

Change in SMBG 9-point Profile: Mean of Postprandial Plasma Glucose Increments (From Before Meal to 90 Minutes After Breakfast, Lunch and Dinner)

Time frame:Week 0, week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Insulin Degludec/Liraglutide	-0.76	—
Insulin Degludec	0.70	—

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG)

Time frame:week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Responder (Yes/no): HbA1c Less Than 7.0%

Time frame:After 26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight Gain

Time frame:After 26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg)

LOINC 4548-4

Secondary/protocol endpoint

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

Time frame:After 26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

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 Treatment

Time frame:After 26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Severe hypoglycemia, Documented hypoglycemia

LOINC 4548-4

Secondary/protocol endpoint

Responder (Yes/no): HbA1c Less Than or Equal to 6.5%

Time frame:After 26 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Responder (Yes/no): HbA1c Less Than or Equal to 6.5% and Without Weight Gain

Time frame:After 26 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

componentsHbA1c <6.5% achievement, Body weight, absolute change (kg)

LOINC 4548-4

Secondary/protocol endpoint

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 Treatment

Time frame:After 26 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Time frame:After 26 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Self-measured Blood Glucose (SMBG) 9-point Profile (Individual Points in the Profile)

Time frame:After 26 weeks

Postprandial glucose

descriptive, improvement

Secondary/protocol endpoint

Change in SMBG 9-point Profile: Mean of the 9-point Profile

Time frame:Week 0, week 26

change from baseline, improvement

Secondary/protocol endpoint

Change in SMBG 9-point Profile: Mean of Postprandial Plasma Glucose Increments (From Before Meal to 90 Minutes After Breakfast, Lunch and Dinner)

Time frame:Week 0, week 26

Postprandial glucose

change from baseline, improvement

Cardiometabolic biomarkers

6 endpoints

Secondary/registry result

Change in Blood Pressure (Systolic and Diastolic)

Time frame:week 0, week 26

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (mean), mmHg	95% CI
Insulin Degludec/LiraglutideSystolic blood pressure	-0.6	—
Diastolic blood pressure	0.9	—
Insulin DegludecSystolic blood pressure	0.9	—
Diastolic blood pressure	1.2	—

Secondary/registry result

Fasting Lipid Profile

Time frame:Week 0, week 26

ratio, improvement

componentsTotal cholesterol, change, LDL-C, change, HDL-C, change, VLDL, change, Triglycerides, change, Free fatty acids, change

Posted result

Group	Value (geometric_mean), Ratio	95% CI
Insulin Degludec/LiraglutideTotal cholesterol	0.90	—
HDL cholesterol	0.90	—
LDL cholesterol	0.86	—
VLDL cholesterol	1.02	—
Triglycerides	1.02	—
Free fatty acids	0.86	—
Insulin DegludecTotal cholesterol	0.96	—
HDL cholesterol	0.95	—
LDL cholesterol	0.95	—
VLDL cholesterol	0.97	—
Triglycerides	0.97	—
Free fatty acids	0.77	—

Secondary/registry result

Change in Pulse

Time frame:Week 0, week 26

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), beats per minute	95% CI
Insulin Degludec/Liraglutide	6.1	—
Insulin Degludec	-0.2	—

Secondary/protocol endpoint

Change in Blood Pressure (Systolic and Diastolic)

Time frame:week 0, week 26

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Fasting Lipid Profile

Time frame:Week 0, week 26

ratio, improvement

Secondary/protocol endpoint

Change in Pulse

Time frame:Week 0, week 26

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

4 endpoints

Secondary/registry result

Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: Diabetes Therapy-Related Quality of Life (DTR-QOL)Questionnaire

Time frame:week 0, week 26

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Insulin Degludec/LiraglutideTotal score	7.9	—
Burden on social activities and daily activities	5.7	—
Anxiety and dissatisfaction with treatment	12.9	—
Hypoglycaemia	-2.6	—
Satisfaction with treatment	15.8	—
Insulin DegludecTotal score	0.1	—
Burden on social activities and daily activities	0.6	—
Anxiety and dissatisfaction with treatment	0.4	—
Hypoglycaemia	-1.6	—
Satisfaction with treatment	-0.4	—

Secondary/registry result

Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: EuroQol-5D (EQ-5D-5L) Questionnaire

Time frame:week 0, week 26

EQ-5D index

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Insulin Degludec/LiraglutideChange in VAS score	6.3	—
Index score	0.02	—
Insulin DegludecChange in VAS score	-1.0	—
Index score	-0.01	—

Secondary/protocol endpoint

Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: Diabetes Therapy-Related Quality of Life (DTR-QOL)Questionnaire

Time frame:week 0, week 26

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: EuroQol-5D (EQ-5D-5L) Questionnaire

Time frame:week 0, week 26

EQ-5D index

change from baseline, improvement

Safety / tolerability / PK

13 endpoints

Secondary/registry result

Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes

Time frame:During 26 weeks of treatment

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Number of episodes	95% CI
Insulin Degludec/Liraglutide	124	—
Insulin Degludec	109	—

Secondary/registry result

Number of Treatment Emergent Adverse Events (TEAE)

Time frame:During 26 weeks of treatment

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Number of events	95% CI
Insulin Degludec/Liraglutide	280	—
Insulin Degludec	210	—

Secondary/registry result

Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:During 26 weeks of treatment

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Number of episodes	95% CI
Insulin Degludec/Liraglutide	52	—
Insulin Degludec	43	—

Secondary/registry result

Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition

Time frame:During 26 weeks of treatment

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Number of episodes	95% CI
Insulin Degludec/Liraglutide	780	—
Insulin Degludec	717	—

Secondary/registry result

Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:During 26 weeks of treatment

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Number of episodes	95% CI
Insulin Degludec/Liraglutide	4	—
Insulin Degludec	8	—

Secondary/registry result

Change in Clinical Evaluation: Fundoscopy or Fundus Photography

Time frame:Screening (week -2 to week 0), week 26

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideLeft eye - at screening visit - normal	53	—
Left eye - at screening visit - Abn, NCS	6	—
Left eye - at screening visit - Abn, CS	46	—
Left eye - week 26 - normal	54	—
Left eye - week 26 - Abn, NCS	7	—
Left eye - week 26 - Abn, CS	44	—
Right eye - at screening visit - normal	55	—
Right eye - at screening visit - Abn, NCS	7	—
Right eye - at screening visit - Abn, CS	43	—
Right eye - week 26 - normal	52	—
Right eye - week 26 - Abn, NCS	8	—
Right eye - week 26 - Abn, CS	45	—
Insulin DegludecLeft eye - at screening visit - normal	70	—
Left eye - at screening visit - Abn, NCS	5	—
Left eye - at screening visit - Abn, CS	30	—
Left eye - week 26 - normal	64	—
Left eye - week 26 - Abn, NCS	7	—
Left eye - week 26 - Abn, CS	34	—
Right eye - at screening visit - normal	72	—
Right eye - at screening visit - Abn, NCS	6	—
Right eye - at screening visit - Abn, CS	27	—
Right eye - week 26 - normal	69	—
Right eye - week 26 - Abn, NCS	6	—
Right eye - week 26 - Abn, CS	30	—

Secondary/registry result

Change in Clinical Evaluation: Electrocardiogram (ECG)

Time frame:Screening (week -2 to week 0), week 26

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideAt screening visit - normal	80	—
At screening visit - Abn, NCS	20	—
At screening visit - Abn, CS	5	—
Week 26 -normal	82	—
Week 26 - Abn, NCS	17	—
Week 26 - Abn, CS	6	—
Insulin DegludecAt screening visit - normal	82	—
At screening visit - Abn, NCS	18	—
At screening visit - Abn, CS	5	—
Week 26 -normal	82	—
Week 26 - Abn, NCS	20	—
Week 26 - Abn, CS	3	—

Secondary/protocol endpoint

Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes

Time frame:During 26 weeks of treatment

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAE)

Time frame:During 26 weeks of treatment

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:During 26 weeks of treatment

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition

Time frame:During 26 weeks of treatment

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:During 26 weeks of treatment

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Change in Clinical Evaluation: Electrocardiogram (ECG)

Time frame:Screening (week -2 to week 0), week 26

categorical status, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Change in Clinical Evaluation: Fundoscopy or Fundus Photography

Time frame:Screening (week -2 to week 0), week 26

categorical status, descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Daily Insulin Dose

Time frame:After 26 weeks

descriptive

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Efficacy and safety of the fixed-ratio combination of insulin degludec and liraglutide by baseline glycated hemoglobin, body mass index and age in Japanese individuals with type 2 diabetes: A subgroup analysis of two phase III trials.
Journal of diabetes investigation2021 Sep (month)PMID33595901doi:10.1111/jdi.13525via CT.gov reference
IDegLira Improves Glycemic Control in Japanese Patients with Uncontrolled Type 2 Diabetes on Premixed Insulin Therapy.
Diabetes therapy : research, treatment and education of diabetes and related disorders2020 Jan (month)PMID31760599doi:10.1007/s13300-019-00730-yvia clinicaltrials gov reference derived + pubmed nct search
Superior HbA1c control with the fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with a maximum dose of 50 units of insulin degludec in Japanese individuals with type 2 diabetes in a phase 3, double-blind, randomized trial.
Diabetes, obesity & metabolism2019 Dec (month)PMID31423685doi:10.1111/dom.13859via CT.gov reference

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.