CompletedPhase 3Results posted

A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus.

A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

635

Study population

Type 2 diabetes

Eligibility highlights

•HbA1c 7.5-10%

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02505334

Org study IDNN2211-4174

Secondary IDJapicCTI-152975JAPIC

Secondary IDU1111-1164-5462WHO

Timeline

Milestones

Study start2015-07-21actual

Study first posted2015-07-22estimated

Primary completion2017-05-02actual

Study completion2017-11-09actual

Results first posted2018-06-25actual

Last update posted2018-09-05actual

Assets

Investigational agents

Liraglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age20 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female Japanese subjects at least 20 years of age at the time of informed consent

•Type 2 diabetes subjects (diagnosed clinically) for at least 6 months prior to screening

•HbA1c 7.5-10.0% [58 mmol/mol-86 mmol/mol] (both inclusive)

•Subjects on stable therapy with one OAD (oral antidiabetic drug) (stable therapy is defined as unchanged medication and unchanged dose) for for at least 60 days before screening according to approved Japanese labelling

Exclusion criteria

•Treatment with insulin within 12 weeks prior to screening

•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

•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

•Within the past 180 days any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack

•Diagnosis of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer, polyps and in-situ carcinomas)

•Any condition which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol

Endpoints (122)

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

Safety / tolerability / PK

Glycemic / diabetes

Cardiometabolic biomarkers

Weight & body composition

MASH / liver

Renal / kidney

Other (unclassified)

Other clinical outcomes

Weight & body composition

6 endpoints

Secondary/registry result

Change in Waist Circumference

Time frame:Week 0, Week 26, Week 52

Waist circumference, change

change from baseline, improvement

Posted result

Group	Mean · Centimeter (cm)	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	93.68	-
Week 26: Change from baseline	-0.44	-
Week 52: Change from baseline	-1.07	-
Liraglutide 0.9 mgWeek 0: Baseline	93.82	-
Week 26: Change from baseline	-0.73	-

Secondary/registry result

Change in Body Weight

Time frame:Week 0, Week 26, Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Mean · Kilogram (kg)	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	74.67	-
Week 26: Change from baseline	-0.77	-
Week 52: Change from baseline	-1.05	-
Liraglutide 0.9 mgWeek 0: Baseline	75.13	-
Week 26: Change from baseline	-0.95	-

Secondary/registry result

Change in Body Mass Index (BMI)

Time frame:Week 0, Week 26, Week 52

BMI, change

change from baseline, improvement

Posted result

Group	Mean · kg/m^2	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	27.34	-
Week 26: Change from baseline	-0.28	-
Week 52: Change from baseline	-0.39	-
Liraglutide 0.9 mgWeek 0: Baseline	27.20	-
Week 26: Change from baseline	-0.33	-

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Week 0, Week 26, Week 52

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight

Time frame:Week 0, Week 26, Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI)

Time frame:Week 0, Week 26, Week 52

BMI, change

change from baseline, improvement

Glycemic / diabetes

33 endpoints

Primary/registry result

Change in Glycosylated Haemoglobin (HbA1c) (Week 26)

Time frame:Week 0, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · Percentage (%) of HbA1c	95% CI
Liraglutide 1.8 mg	-0.23	-
Liraglutide 0.9 mg	0.17	-

Treatment difference-0.4095% CI-0.55 - -0.24p<0.0001ANCOVA

Primary/protocol endpoint

Change in Glycosylated Haemoglobin (HbA1c) (Week 26)

Time frame:Week 0, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change in HbA1c (Week 52)

Time frame:Week 0, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Mean · Percentage (%) of HbA1c	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	8.14	-
Week 52: Change from baseline	-0.09	-

Secondary/registry result

Responder for HbA1c Below 7.0% (53 mmol/Mol)

Time frame:Week 26 and Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
Liraglutide 1.8 mgWeek 26	53	-
Week 52	45	-
Liraglutide 0.9 mgWeek 26	18	-

Secondary/registry result

Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)

Time frame:Week 26 and Week 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
Liraglutide 1.8 mgWeek 26	18	-
Week 52	16	-
Liraglutide 0.9 mgWeek 26	5	-

Secondary/registry result

Responder for HbA1c Below 7.0% Without Weight Gain

Time frame:Week 26 and Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
Liraglutide 1.8 mgWeek 26	36	-
Week 52	35	-
Liraglutide 0.9 mgWeek 26	13	-

Secondary/registry result

Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 26 and Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Participants	95% CI
Liraglutide 1.8 mgWeek 26	53	-
Week 52	45	-
Liraglutide 0.9 mgWeek 26	18	-

Secondary/registry result

Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)

Time frame:Week 0 and Week 26 and Week 52

Postprandial glucose

change from baseline, improvement

Posted result

Group	Mean · mg/dL	95% CI
Liraglutide 1.8 mgWeek 0: Before breakfast	181.8	-
Week 0: 90 minutes after start of breakfast	262.6	-
Week 0: Before lunch	169.5	-
Week 0: 90 minutes after start of lunch	253.1	-
Week 0: Before dinner	173.4	-
Week 0: 90 minutes after start of dinner	254.3	-
Week 0: At bedtime	226.1	-
Week 26: Before breakfast	171.7	-
Week 26: 90 minutes after start of breakfast	247.2	-
Week 26: Before lunch	161.2	-
Week 26: 90 minutes after start of lunch	234.7	-
Week 26: Before dinner	162.3	-
Week 26: 90 minutes after start of dinner	233.3	-
Week 26: At bedtime	205.6	-
Week 52: Before breakfast	176.1	-
Week 52: 90 minutes after start of breakfast	251.1	-
Week 52: Before lunch	169.6	-
Week 52: 90 minutes after start of lunch	243.3	-
Week 52: Before dinner	164.3	-
Week 52: 90 minutes after start of dinner	240.5	-
Week 52: At bedtime	207.9	-
Liraglutide 0.9 mgWeek 0: Before breakfast	177.1	-
Week 0: 90 minutes after start of breakfast	266.5	-
Week 0: Before lunch	177.6	-
Week 0: 90 minutes after start of lunch	252.2	-
Week 0: Before dinner	169.7	-
Week 0: 90 minutes after start of dinner	249.5	-
Week 0: At bedtime	217.8	-
Week 26: Before breakfast	178.2	-
Week 26: 90 minutes after start of breakfast	258.2	-
Week 26: Before lunch	177.0	-
Week 26: 90 minutes after start of lunch	255.3	-
Week 26: Before dinner	168.6	-
Week 26: 90 minutes after start of dinner	251.5	-
Week 26: At bedtime	220.5	-

Secondary/registry result

Change in SMBG 7-point Profile: Mean of 7-point Profile

Time frame:Week 0, Week 26, Week 52

change from baseline, improvement

Posted result

Group	Mean · mg/dL	95% CI
Liraglutide 1.8 mgBaseline (week 0)	217.9	-
Change from baseline: week 26	-14.5	-
Change from baseline: week 52	-8.9	-
Liraglutide 0.9 mgBaseline (week 0)	217.7	-
Change from baseline: week 26	-0.6	-

Secondary/registry result

Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)

Time frame:Week 0, Week 26, Week 52

Postprandial glucose

change from baseline, improvement

Posted result

Group	Mean · mg/dL	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	81.7	-
Week 26: Change from baseline	-8.4	-
Week 52: Change from baseline	-6.3	-
Liraglutide 0.9 mgWeek 0: Baseline	81.6	-
Week 26: Change from baseline	-1.5	-

Secondary/registry result

Change in Fasting Plasma Glucose (FPG)

Time frame:Week 0, Week 26, Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Mean · mg/dL	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	172.5	-
Week 26: Change from baseline	-8.4	-
Week 52: Change from baseline	-1.2	-
Liraglutide 0.9 mgWeek 0: Baseline	172.0	-
Week 26: Change from baseline	1.0	-

Secondary/registry result

Fasting C-peptide

Time frame:Week 26 and Week 52

descriptive

Posted result

Group	Geometric mean · ng/mL	95% CI
Liraglutide 1.8 mgWeek 26	1.946	-
Week 52	1.906	-
Liraglutide 0.9 mgWeek 26	1.853	-

Secondary/registry result

Fasting Insulin

Time frame:Week 26 and Week 52

concentration, descriptive

Posted result

Group	Geometric mean · pmol/L	95% CI
Liraglutide 1.8 mgWeek 26	77.00	-
Week 52	77.31	-
Liraglutide 0.9 mgWeek 26	70.91	-

Secondary/registry result

Fasting Glucagon

Time frame:Week 26 and Week 52

concentration, descriptive

Posted result

Group	Geometric mean · pmol/L	95% CI
Liraglutide 1.8 mgWeek 26	22.5	-
Week 52	23.4	-
Liraglutide 0.9 mgWeek 26	23.4	-

Secondary/registry result/low confidence

Proinsulin

Time frame:Week 26 and Week 52

concentration, descriptive

Posted result

Group	Geometric mean · pmol/L	95% CI
Liraglutide 1.8 mgWeek 26	15.638	-
Week 52	16.217	-
Liraglutide 0.9 mgWeek 26	16.054	-

Secondary/registry result

Proinsulin/Insulin

Time frame:Week 26 and Week 52

ratio, improvement

Posted result

Group	Geometric mean · Percentage (%) of proinsulin/insulin	95% CI
Liraglutide 1.8 mgWeek 26	20.31	-
Week 52	20.98	-
Liraglutide 0.9 mgWeek 26	22.64	-

Secondary/registry result

Homeostasis Model Assessment of Beta-cell Function (HOMA-B)

Time frame:Week 26 and Week 52

change from baseline, improvement

Posted result

Group	Geometric mean · Percentage (%) of beta-cell function	95% CI
Liraglutide 1.8 mgWeek 26	42.06	-
Week 52	40.03	-
Liraglutide 0.9 mgWeek 26	35.54	-

Secondary/registry result

Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)

Time frame:Week 26 and Week 52

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Geometric mean · HOMA-IR score	95% CI
Liraglutide 1.8 mgWeek 26	4.388	-
Week 52	4.567	-
Liraglutide 0.9 mgWeek 26	4.262	-

Secondary/protocol endpoint

Change in HbA1c (Week 52)

Time frame:Week 0, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Responder for HbA1c Below 7.0% (53 mmol/Mol)

Time frame:Week 26 and Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)

Time frame:Week 26 and Week 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Responder for HbA1c Below 7.0% Without Weight Gain

Time frame:Week 26 and Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 26 and Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)

Time frame:Week 0 and Week 26 and Week 52

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in SMBG 7-point Profile: Mean of 7-point Profile

Time frame:Week 0, Week 26, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)

Time frame:Week 0, Week 26, Week 52

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG)

Time frame:Week 0, Week 26, Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Fasting C-peptide

Time frame:Week 26 and Week 52

change from baseline, improvement

Secondary/protocol endpoint

Fasting Insulin

Time frame:Week 26 and Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Proinsulin

Time frame:Week 26 and Week 52

descriptive

Secondary/protocol endpoint

Proinsulin/Insulin

Time frame:Week 26 and Week 52

ratio, improvement

Secondary/protocol endpoint

Homeostasis Model Assessment of Beta-cell Function (HOMA-B)

Time frame:Week 26 and Week 52

change from baseline, improvement

Secondary/protocol endpoint

Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)

Time frame:Week 26 and Week 52

HOMA-IR (insulin sensitivity)

change from baseline, improvement

MASH / liver

6 endpoints

Secondary/registry result

Change in Biochemistry: Alanine Aminotransferase

Time frame:Week 0, Week 26, Week 52

ALT, change

change from baseline, improvement

LOINC 1742-6

Posted result

Group	Mean · U/L	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	32.7	-
Week 26: Change from baseline	-0.4	-
Week 52: Change from baseline	-2.4	-
Liraglutide 0.9 mgWeek 0: Baseline	34.2	-
Week 26: Change from baseline	-2.2	-

Secondary/registry result

Change in Biochemistry: Aspartate Aminotransferase

Time frame:Week 0, Week 26, Week 52

AST, change

change from baseline, improvement

LOINC 1920-8

Posted result

Group	Mean · U/L	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	26.5	-
Week 26: Change from baseline	0.2	-
Week 52: Change from baseline	-1.2	-
Liraglutide 0.9 mgWeek 0: Baseline	26.9	-
Week 26: Change from baseline	-1.0	-

Secondary/registry result

Change in Biochemistry: Alkaline Phosphatase

Time frame:Week 0, Week 26, Week 52

change from baseline, improvement

Posted result

Group	Mean · U/L	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	72.5	-
Week 26: Change from baseline	0.6	-
Week 52: Change from baseline	2.1	-
Liraglutide 0.9 mgWeek 0: Baseline	74.1	-
Week 26: Change from baseline	2.0	-

Secondary/protocol endpoint

Change in Biochemistry: Alanine Aminotransferase

Time frame:Week 0, Week 26, Week 52

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Change in Biochemistry: Aspartate Aminotransferase

Time frame:Week 0, Week 26, Week 52

AST, change

change from baseline, improvement

LOINC 1920-8

Secondary/protocol endpoint

Change in Biochemistry: Alkaline Phosphatase

Time frame:Week 0, Week 26, Week 52

change from baseline, improvement

Renal / kidney

6 endpoints

Secondary/registry result

Change in Biochemistry: Creatinine

Time frame:Week 0, Week 26, Week 52

change from baseline, improvement

LOINC 2160-0

Posted result

Group	Mean · mg/dL	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	0.802	-
Week 26: Change from baseline	0.018	-
Week 52: Change from baseline	0.025	-
Liraglutide 0.9 mgWeek 0: Baseline	0.822	-
Week 26: Change from baseline	0.011	-

Secondary/registry result

Change in Biochemistry: eGFR

Time frame:Week 0, Week 26, Week 52

eGFR, change

change from baseline, improvement

LOINC 98979-8

Posted result

Group	Mean · mL/min/1.73m^2	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	78.6	-
Week 26: Change from baseline	-1.5	-
Week 52: Change from baseline	-2.3	-
Liraglutide 0.9 mgWeek 0: Baseline	77.6	-
Week 26: Change from baseline	-1.0	-

Secondary/registry result/low confidence

Change in Biochemistry: Urea

Time frame:Week 0, Week 26, Week 52

change from baseline, improvement

Posted result

Group	Mean · mg/dL	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	13.5	-
Week 26: Change from baseline	0.3	-
Week 52: Change from baseline	0.7	-
Liraglutide 0.9 mgWeek 0: Baseline	14.0	-
Week 26: Change from baseline	-0.0	-

Secondary/protocol endpoint

Change in Biochemistry: Creatinine

Time frame:Week 0, Week 26, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in Biochemistry: eGFR

Time frame:Week 0, Week 26, Week 52

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Change in Biochemistry: Urea

Time frame:Week 0, Week 26, Week 52

change from baseline, improvement

Cardiometabolic biomarkers

16 endpoints

Secondary/registry result

Change in Blood Pressure (Systolic and Diastolic)

Time frame:Week 0, Week 26, Week 52

change from baseline, improvement

Posted result

Group	Mean · mmHg	95% CI
Liraglutide 1.8 mgWeek 0: SBP, Baseline	128.0	-
Week 26: SBP, change from baseline	-1.7	-
Week 52: SBP, change from baseline	-0.9	-
Week 0: DBP, Baseline	79.6	-
Week 26: DBP, change from baseline	-0.9	-
Week 52: DBP, change from baseline	-0.6	-
Liraglutide 0.9 mgWeek 0: SBP, Baseline	128.8	-
Week 26: SBP, change from baseline	0.4	-
Week 0: DBP, Baseline	80.3	-
Week 26: DBP, change from baseline	0.1	-

Secondary/registry result

Total Cholesterol

Time frame:Week 26 and Week 52

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Geometric mean · mg/dL	95% CI
Liraglutide 1.8 mgWeek 26	191.2	-
Week 52	190.6	-
Liraglutide 0.9 mgWeek 26	194.5	-

Secondary/registry result

Low Density Lipoprotein (LDL) Cholesterol

Time frame:Week 26 and Week 52

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Geometric mean · mg/dL	95% CI
Liraglutide 1.8 mgWeek 26	103.4	-
Week 52	104.5	-
Liraglutide 0.9 mgWeek 26	107.1	-

Secondary/registry result

High Density Lipoprotein (HDL) Cholesterol

Time frame:Week 26 and Week 52

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Geometric mean · mg/dL	95% CI
Liraglutide 1.8 mgWeek 26	52.7	-
Week 52	53.3	-
Liraglutide 0.9 mgWeek 26	52.9	-

Secondary/registry result

Very Low Density Lipoprotein (VLDL) Cholesterol

Time frame:Week 26 and Week 52

VLDL, change

change from baseline, improvement

Posted result

Group	Geometric mean · mg/dL	95% CI
Liraglutide 1.8 mgWeek 26	26.8	-
Week 52	25.9	-
Liraglutide 0.9 mgWeek 26	27.8	-

Secondary/registry result

Triglycerides

Time frame:Week 26 and Week 52

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Geometric mean · mg/dL	95% CI
Liraglutide 1.8 mgWeek 26	135.4	-
Week 52	130.4	-
Liraglutide 0.9 mgWeek 26	142.3	-

Secondary/registry result

Free Fatty Acids

Time frame:Week 26 and Week 52

Free fatty acids, change

change from baseline, improvement

Posted result

Group	Geometric mean · mg/dL	95% CI
Liraglutide 1.8 mgWeek 26	12.56	-
Week 52	12.19	-
Liraglutide 0.9 mgWeek 26	12.99	-

Secondary/registry result

Change in Pulse

Time frame:Week 0, Week 26, Week 52

Heart rate, change

change from baseline, improvement

Posted result

Group	Mean · Beats/minute	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	80.2	-
Week 26: Change from baseline	0.8	-
Week 52: Change from baseline	0.2	-
Liraglutide 0.9 mgWeek 0: Baseline	80.8	-
Week 26: Change from baseline	0.2	-

Secondary/protocol endpoint

Change in Blood Pressure (Systolic and Diastolic)

Time frame:Week 0, Week 26, Week 52

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Total Cholesterol

Time frame:Week 26 and Week 52

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Low Density Lipoprotein (LDL) Cholesterol

Time frame:Week 26 and Week 52

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

High Density Lipoprotein (HDL) Cholesterol

Time frame:Week 26 and Week 52

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Very Low Density Lipoprotein (VLDL) Cholesterol

Time frame:Week 26 and Week 52

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Triglycerides

Time frame:Week 26 and Week 52

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Free Fatty Acids

Time frame:Week 26 and Week 52

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Pulse

Time frame:Week 0, Week 26, Week 52

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

47 endpoints

Secondary/registry result

Number of Treatment Emergent Adverse Events

Time frame:Weeks 0-26 and Weeks 0-52

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Number · Events	95% CI
Liraglutide 1.8 mgWeeks 0-26	365	-
Weeks 0-52	588	-
Liraglutide 0.9 mgWeeks 0-26	266	-

Secondary/registry result

Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Weeks 0-26 and Weeks 0-52

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Number · Episodes	95% CI
Liraglutide 1.8 mgWeeks 0-26	0	-
Weeks 0-52	0	-
Liraglutide 0.9 mgWeeks 0-26	0	-

Secondary/registry result

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

Time frame:Weeks 0-26 and Weeks 0-52

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Number · Episodes	95% CI
Liraglutide 1.8 mgWeeks 0-26	0	-
Weeks 0-52	0	-
Liraglutide 0.9 mgWeeks 0-26	0	-

Secondary/registry result

Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition

Time frame:Weeks 0-26 and Weeks 0-52

Documented hypoglycemia

event count, event

Posted result

Group	Number · Episodes	95% CI
Liraglutide 1.8 mgWeeks 0-26: Severe hypoglycaemia	0	-
Weeks 0-26: Documented symptomatic hypoglycaemia	0	-
Weeks 0-26: Asymptomatic hypoglycaemia	2	-
Weeks 0-26: Probable symptomatic hypoglycaemia	3	-
Weeks 0-26: Pseudo-hypoglycaemia	2	-
Weeks 0-52: Severe hypoglycaemia	0	-
Weeks 0-52: Documented symptomatic hypoglycaemia	0	-
Weeks 0-52: Asymptomatic hypoglycaemia	3	-
Weeks 0-52: Probable symptomatic hypoglycaemia	4	-
Weeks 0-52: Pseudo-hypoglycaemia	2	-
Liraglutide 0.9 mgWeeks 0-26: Severe hypoglycaemia	0	-
Weeks 0-26: Documented symptomatic hypoglycaemia	0	-
Weeks 0-26: Asymptomatic hypoglycaemia	1	-
Weeks 0-26: Probable symptomatic hypoglycaemia	1	-
Weeks 0-26: Pseudo-hypoglycaemia	1	-

Secondary/registry result

Change in Physical Examination

Time frame:Week 0 and Week 26 and Week 52

descriptive

Posted result

Group	Participants	95% CI
Liraglutide 1.8 mgCardiovascular system: Wk 0: Normal	229	-
Cardiovascular system: Wk 0: Abnormal, NCS	3	-
Cardiovascular system: Wk 0: Abnormal, CS	1	-
Cardiovascular system: Wk 26: Normal	230	-
Cardiovascular system: Wk 26: Abnormal, NCS	2	-
Cardiovascular system: Week 26: Abnormal, CS	1	-
Cardiovascular system: Wk 52: Normal	227	-
Cardiovascular system: Wk 52: Abnormal, NCS	4	-
Cardiovascular system: Wk 52: Abnormal, CS	2	-
Central and PNS: Wk 0: Normal	232	-
Central and PNS: Wk 0: Abnormal, NCS	0	-
Central and PNS: Wk 0: Abnormal, CS	1	-
Central and PNS: Wk 26: Normal	231	-
Central and PNS: Wk 26: Abnormal, NCS	0	-
Central and PNS: Wk 26: Abnormal, CS	2	-
Central and PNS: Wk 52: Normal	232	-
Central and PNS: Wk 52: Abnormal, NCS	0	-
Central and PNS: Wk 52: Abnormal, CS	1	-
GI system including mouth: Wk 0: Normal	227	-
GI system including mouth: Wk 0: Abnormal, NCS	0	-
GI system including mouth: Wk 0: Abnormal, CS	6	-
GI system including mouth: Wk 26: Normal	227	-
GI system including mouth: Wk 26: Abnormal, NCS	0	-
GI system including mouth: Wk 26: Abnormal, CS	6	-
GI system including mouth: Wk 52: Normal	226	-
GI system including mouth: Wk 52: Abnormal, NCS	2	-
GI system including mouth: Wk 52: Abnormal, CS	5	-
General appearance: Wk 0: Normal	229	-
General appearance: Wk 0: Abnormal, NCS	4	-
General appearance: Wk 0: Abnormal, CS	0	-
General appearance: Wk 26: Normal	229	-
General appearance: Wk 26: Abnormal, NCS	4	-
General appearance: Wk 26: Abnormal, CS	0	-
General appearance: Wk 52: Normal	229	-
General appearance: Wk 52: Abnormal, NCS	4	-
General appearance: Wk 52: Abnormal, CS	0	-
Head,ears,eyes,nose,throat,neck: Wk0:Normal	225	-
Head,ears,eyes,nose,throat,neck: Wk0:Abnormal,NCS	3	-
Head,ears,eyes,nose,throat,neck: Wk0:Abnormal,CS	5	-
Head,ears,eyes,nose,throat,neck: Wk26:Normal	225	-
Head,ears,eyes,nose,throat,neck: Wk26:Abnormal,NCS	4	-
Head,ears,eyes,nose,throat,neck: Wk26:Abnormal,CS	4	-
Head,ears,eyes,nose,throat,neck: Wk52:Normal	223	-
Head,ears,eyes,nose,throat,neck: Wk52:Abnormal,NCS	5	-
Head,ears,eyes,nose,throat,neck: Wk52:Abnormal,CS	5	-
Lymph node palpation: Wk 0: Normal	233	-
Lymph node palpation: Wk 0: Abnormal, NCS	0	-
Lymph node palpation: Wk 0: Abnormal, CS	0	-
Lymph node palpation: Wk 26: Normal	233	-
Lymph node palpation: Wk 26: Abnormal, NCS	0	-
Lymph node palpation: Wk 26: Abnormal, CS	0	-
Lymph node palpation: Wk 52: Normal	233	-
Lymph node palpation: Wk 52: Abnormal, NCS	0	-
Lymph node palpation: Wk 52: Abnormal, CS	0	-
Musculoskeletal system: Wk 0: Normal	226	-
Musculoskeletal system: Wk 0: Abnormal, NCS	4	-
Musculoskeletal system: Wk 0: Abnormal, CS	3	-
Musculoskeletal system: Wk 26: Normal	224	-
Musculoskeletal system: Wk 26: Abnormal, NCS	5	-
Musculoskeletal system: Wk 26: Abnormal, CS	4	-
Musculoskeletal system: Wk 52: Normal	224	-
Musculoskeletal system: Wk 52: Abnormal, NCS	5	-
Musculoskeletal system: Wk 52: Abnormal, CS	4	-
Respiratory system: Wk 0: Normal	233	-
Respiratory system: Wk 0: Abnormal, NCS	0	-
Respiratory system: Wk 0: Abnormal, CS	0	-
Respiratory system: Wk 26: Normal	232	-
Respiratory system: Wk 26: Abnormal, NCS	0	-
Respiratory system: Wk 26: Abnormal, CS	1	-
Respiratory system: Wk 52: Normal	232	-
Respiratory system: Wk 52: Abnormal, NCS	0	-
Respiratory system: Wk 52: Abnormal, CS	1	-
Skin: Wk 0: Normal	225	-
Skin: Wk 0: Abnormal, NCS	4	-
Skin: Wk 0: Abnormal, CS	4	-
Skin: Wk 26: Normal	218	-
Skin: Wk 26: Abnormal, NCS	4	-
Skin: Wk 26: Abnormal, CS	11	-
Skin: Wk 52: Normal	224	-
Skin: Wk 52: Abnormal, NCS	4	-
Skin: Wk 52: Abnormal, CS	5	-
Thyroid gland: Wk 0: Normal	232	-
Thyroid gland: Wk 0: Abnormal, NCS	0	-
Thyroid gland: Wk 0: Abnormal, CS	1	-
Thyroid gland: Wk 26: Normal	232	-
Thyroid gland: Wk 26: Abnormal, NCS	0	-
Thyroid gland: Wk 26: Abnormal, CS	1	-
Thyroid gland: Wk 52: Normal	232	-
Thyroid gland: Wk 52: Abnormal, NCS	0	-
Thyroid gland: Wk 52: Abnormal, CS	1	-
Liraglutide 0.9 mgCardiovascular system: Wk 0: Normal	230	-
Cardiovascular system: Wk 0: Abnormal, NCS	0	-
Cardiovascular system: Wk 0: Abnormal, CS	3	-
Cardiovascular system: Wk 26: Normal	229	-
Cardiovascular system: Wk 26: Abnormal, NCS	0	-
Cardiovascular system: Week 26: Abnormal, CS	4	-
Central and PNS: Wk 0: Normal	229	-
Central and PNS: Wk 0: Abnormal, NCS	1	-
Central and PNS: Wk 0: Abnormal, CS	3	-
Central and PNS: Wk 26: Normal	229	-
Central and PNS: Wk 26: Abnormal, NCS	1	-
Central and PNS: Wk 26: Abnormal, CS	3	-
GI system including mouth: Wk 0: Normal	226	-
GI system including mouth: Wk 0: Abnormal, NCS	4	-
GI system including mouth: Wk 0: Abnormal, CS	3	-
GI system including mouth: Wk 26: Normal	226	-
GI system including mouth: Wk 26: Abnormal, NCS	3	-
GI system including mouth: Wk 26: Abnormal, CS	4	-
General appearance: Wk 0: Normal	232	-
General appearance: Wk 0: Abnormal, NCS	1	-
General appearance: Wk 0: Abnormal, CS	0	-
General appearance: Wk 26: Normal	233	-
General appearance: Wk 26: Abnormal, NCS	0	-
General appearance: Wk 26: Abnormal, CS	0	-
Head,ears,eyes,nose,throat,neck: Wk0:Normal	226	-
Head,ears,eyes,nose,throat,neck: Wk0:Abnormal,NCS	2	-
Head,ears,eyes,nose,throat,neck: Wk0:Abnormal,CS	5	-
Head,ears,eyes,nose,throat,neck: Wk26:Normal	228	-
Head,ears,eyes,nose,throat,neck: Wk26:Abnormal,NCS	1	-
Head,ears,eyes,nose,throat,neck: Wk26:Abnormal,CS	4	-
Lymph node palpation: Wk 0: Normal	233	-
Lymph node palpation: Wk 0: Abnormal, NCS	0	-
Lymph node palpation: Wk 0: Abnormal, CS	0	-
Lymph node palpation: Wk 26: Normal	233	-
Lymph node palpation: Wk 26: Abnormal, NCS	0	-
Lymph node palpation: Wk 26: Abnormal, CS	0	-
Musculoskeletal system: Wk 0: Normal	231	-
Musculoskeletal system: Wk 0: Abnormal, NCS	0	-
Musculoskeletal system: Wk 0: Abnormal, CS	2	-
Musculoskeletal system: Wk 26: Normal	230	-
Musculoskeletal system: Wk 26: Abnormal, NCS	0	-
Musculoskeletal system: Wk 26: Abnormal, CS	3	-
Respiratory system: Wk 0: Normal	232	-
Respiratory system: Wk 0: Abnormal, NCS	1	-
Respiratory system: Wk 0: Abnormal, CS	0	-
Respiratory system: Wk 26: Normal	232	-
Respiratory system: Wk 26: Abnormal, NCS	1	-
Respiratory system: Wk 26: Abnormal, CS	0	-
Skin: Wk 0: Normal	223	-
Skin: Wk 0: Abnormal, NCS	3	-
Skin: Wk 0: Abnormal, CS	7	-
Skin: Wk 26: Normal	222	-
Skin: Wk 26: Abnormal, NCS	4	-
Skin: Wk 26: Abnormal, CS	7	-
Thyroid gland: Wk 0: Normal	232	-
Thyroid gland: Wk 0: Abnormal, NCS	0	-
Thyroid gland: Wk 0: Abnormal, CS	1	-
Thyroid gland: Wk 26: Normal	232	-
Thyroid gland: Wk 26: Abnormal, NCS	0	-
Thyroid gland: Wk 26: Abnormal, CS	1	-

Secondary/registry result

Change in Electrocardiogram (ECG)

Time frame:Week 0 and Week 26 and Week 52

categorical status, descriptive

Posted result

Group	Participants	95% CI
Liraglutide 1.8 mgWeek 0: Normal	202	-
Week 0: Abnormal, NCS	31	-
Week 0: Abnormal, CS	0	-
Week 26: Normal	205	-
Week 26: Abnormal, NCS	26	-
Week 26: Abnormal, CS	2	-
Week 52: Normal	203	-
Week 52: Abnormal, NCS	28	-
Week 52: Abnormal, CS	2	-
Liraglutide 0.9 mgWeek 0: Normal	196	-
Week 0: Abnormal, NCS	35	-
Week 0: Abnormal, CS	2	-
Week 26: Normal	204	-
Week 26: Abnormal, NCS	26	-
Week 26: Abnormal, CS	3	-

Secondary/registry result

Change in Biochemistry: Sodium

Time frame:Week 0, Week 26, Week 52

change from baseline, descriptive

Posted result

Group	Mean · mmol/L	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	140.2	-
Week 26: Change from baseline	0.1	-
Week 52: Change from baseline	0.3	-
Liraglutide 0.9 mgWeek 0: Baseline	140.2	-
Week 26: Change from baseline	0.2	-

Secondary/registry result

Change in Biochemistry: Potassium

Time frame:Week 0, Week 26, Week 52

change from baseline, descriptive

Posted result

Group	Mean · mmol/L	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	4.40	-
Week 26: Change from baseline	-0.01	-
Week 52: Change from baseline	0.00	-
Liraglutide 0.9 mgWeek 0: Baseline	4.38	-
Week 26: Change from baseline	-0.02	-

Secondary/registry result

Change in Biochemistry: Albumin

Time frame:Week 0, Week 26, Week 52

change from baseline, descriptive

Posted result

Group	Mean · g/L	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	44.7	-
Week 26: Change from baseline	-0.2	-
Week 52: Change from baseline	-0.2	-
Liraglutide 0.9 mgWeek 0: Baseline	45.1	-
Week 26: Change from baseline	-0.2	-

Secondary/registry result

Change in Biochemistry: Total Bilirubin

Time frame:Week 0, Week 26, Week 52

change from baseline, descriptive

Posted result

Group	Mean · mg/dL	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	0.52	-
Week 26: Change from baseline	0.04	-
Week 52: Change from baseline	0.06	-
Liraglutide 0.9 mgWeek 0: Baseline	0.53	-
Week 26: Change from baseline	0.04	-

Secondary/registry result

Change in Biochemistry: Creatine Kinase

Time frame:Week 0, Week 26, Week 52

change from baseline, descriptive

Posted result

Group	Mean · U/L	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	117.3	-
Week 26: Change from baseline	5.2	-
Week 52: Change from baseline	7.5	-
Liraglutide 0.9 mgWeek 0: Baseline	129.3	-
Week 26: Change from baseline	-5.2	-

Secondary/registry result

Change in Biochemistry: Calcium

Time frame:Week 0, Week 26, Week 52

change from baseline, descriptive

Posted result

Group	Mean · mg/dL	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	9.66	-
Week 26: Change from baseline	-0.01	-
Week 52: Change from baseline	0.01	-
Liraglutide 0.9 mgWeek 0: Baseline	9.66	-
Week 26: Change from baseline	0.01	-

Secondary/registry result

Change in Biochemistry: Albumin Corrected Calcium

Time frame:Week 0, Week 26, Week 52

albumin corrected calcium

change from baseline, descriptive

Posted result

Group	Mean · mg/dL	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	9.28	-
Week 26: Change from baseline	0.00	-
Week 52: Change from baseline	0.02	-
Liraglutide 0.9 mgWeek 0: Baseline	9.26	-
Week 26: Change from baseline	0.02	-

Secondary/registry result

Change in Biochemistry: Amylase

Time frame:Week 0, Week 26, Week 52

change from baseline, descriptive

Posted result

Group	Mean · U/L	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	62.3	-
Week 26: Change from baseline	-0.9	-
Week 52: Change from baseline	-0.7	-
Liraglutide 0.9 mgWeek 0: Baseline	61.1	-
Week 26: Change from baseline	-2.3	-

Secondary/registry result

Change in Biochemistry: Lipase

Time frame:Week 0, Week 26, Week 52

change from baseline, descriptive

Posted result

Group	Mean · U/L	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	55.4	-
Week 26: Change from baseline	-1.4	-
Week 52: Change from baseline	-1.0	-
Liraglutide 0.9 mgWeek 0: Baseline	57.3	-
Week 26: Change from baseline	-3.3	-

Secondary/registry result

Change in Haematology: Haemoglobin

Time frame:Week 0, Week 26, Week 52

change from baseline, descriptive

Posted result

Group	Mean · g/dL	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	14.65	-
Week 26: Change from baseline	-0.00	-
Week 52: Change from baseline	-0.00	-
Liraglutide 0.9 mgWeek 0: Baseline	14.56	-
Week 26: Change from baseline	0.04	-

Secondary/registry result

Change in Haematology: Haematocrit

Time frame:Week 0, Week 26, Week 52

change from baseline, descriptive

Posted result

Group	Mean · % of red blood cell	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	44.86	-
Week 26: Change from baseline	-0.22	-
Week 52: Change from baseline	-0.49	-
Liraglutide 0.9 mgWeek 0: Baseline	44.65	-
Week 26: Change from baseline	-0.06	-

Secondary/registry result

Change in Haematology: Thrombocytes

Time frame:Week 0, Week 26 and Week 52

change from baseline, descriptive

Posted result

Group	Mean · 10^9 cells/L	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	229.1	-
Week 26: Change from baseline	0.8	-
Week 52: Change from baseline	3.4	-
Liraglutide 0.9 mgWeek 0: Baseline	231.0	-
Week 26: Change from baseline	-1.5	-

Secondary/registry result

Change in Haematology: Erythrocytes

Time frame:Week 0, Week 26 and Week 52

change from baseline, descriptive

Posted result

Group	Mean · 10^12 cells/L	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	4.87	-
Week 26: Change from baseline	-0.02	-
Week 52: Change from baseline	-0.04	-
Liraglutide 0.9 mgWeek 0: Baseline	4.89	-
Week 26: Change from baseline	-0.00	-

Secondary/registry result

Change in Haematology: Leukocytes

Time frame:Week 0, Week 26 and Week 52

change from baseline, descriptive

Posted result

Group	Mean · 10^9 cells/L	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	6.55	-
Week 26: Change from baseline	0.09	-
Week 52: Change from baseline	0.09	-
Liraglutide 0.9 mgWeek 0: Baseline	6.53	-
Week 26: Change from baseline	-0.08	-

Secondary/registry result

Change in Haematology: Eosinophils

Time frame:Week 0, Week 26 and Week 52

change from baseline, descriptive

Posted result

Group	Mean · 10^9 cells/L	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	0.182	-
Week 26: Change from baseline	0.001	-
Week 52: Change from baseline	-0.008	-
Liraglutide 0.9 mgWeek 0: Baseline	0.167	-
Week 26: Change from baseline	-0.016	-

Secondary/registry result

Change in Haematology: Neutrophils

Time frame:Week 0, Week 26 and Week 52

change from baseline, descriptive

Posted result

Group	Mean · 10^9 cells/L	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	3.967	-
Week 26: Change from baseline	0.054	-
Week 52: Change from baseline	0.062	-
Liraglutide 0.9 mgWeek 0: Baseline	3.975	-
Week 26: Change from baseline	-0.088	-

Secondary/registry result

Change in Haematology: Basophils

Time frame:Week 0, Week 26 and Week 52

change from baseline, descriptive

Posted result

Group	Mean · 10^9 cells/L	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	0.024	-
Week 26: Change from baseline	0.004	-
Week 52: Change from baseline	0.000	-
Liraglutide 0.9 mgWeek 0: Baseline	0.026	-
Week 26: Change from baseline	0.000	-

Secondary/registry result

Change in Haematology: Monocytes

Time frame:Week 0, Week 26 and Week 52

change from baseline, descriptive

Posted result

Group	Mean · 10^9 cells/L	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	0.341	-
Week 26: Change from baseline	0.001	-
Week 52: Change from baseline	0.019	-
Liraglutide 0.9 mgWeek 0: Baseline	0.326	-
Week 26: Change from baseline	-0.000	-

Secondary/registry result

Change in Haematology: Lymphocytes

Time frame:Week 0, Week 26 and Week 52

change from baseline, descriptive

Posted result

Group	Mean · 10^9 cells/L	95% CI
Liraglutide 1.8 mgWeek 0: Baseline	2.034	-
Week 26: Change from baseline	0.032	-
Week 52: Change from baseline	0.014	-
Liraglutide 0.9 mgWeek 0: Baseline	2.037	-
Week 26: Change from baseline	0.022	-

Secondary/registry result

Change in Calcitonin

Time frame:Week 0 and Week 26 and Week 52

Thyroid event

categorical status, event

Posted result

Group	Participants	95% CI
Liraglutide 1.8 mgWeek 0: Low	0	-
Week 0: Normal	229	-
Week 0: High	4	-
Week 26: Low	0	-
Week 26: Normal	228	-
Week 26: High	5	-
Week 52: Low	0	-
Week 52: Normal	230	-
Week 52: High	3	-
Liraglutide 0.9 mgWeek 0: Low	0	-
Week 0: Normal	229	-
Week 0: High	3	-
Week 26: Low	0	-
Week 26: Normal	231	-
Week 26: High	2	-

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events

Time frame:Weeks 0-26 and Weeks 0-52

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Weeks 0-26 and Weeks 0-52

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

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

Time frame:Weeks 0-26 and Weeks 0-52

Severe hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition

Time frame:Weeks 0-26 and Weeks 0-52

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Change in Physical Examination

Time frame:Week 0 and Week 26 and Week 52

descriptive

Secondary/protocol endpoint

Change in Electrocardiogram (ECG)

Time frame:Week 0 and Week 26 and Week 52

categorical status, descriptive

Secondary/protocol endpoint

Change in Biochemistry: Potassium

Time frame:Week 0, Week 26, Week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change in Biochemistry: Creatine Kinase

Time frame:Week 0, Week 26, Week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change in Biochemistry: Calcium

Time frame:Week 0, Week 26, Week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change in Biochemistry: Amylase

Time frame:Week 0, Week 26, Week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change in Biochemistry: Lipase

Time frame:Week 0, Week 26, Week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematology: Haemoglobin

Time frame:Week 0, Week 26, Week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematology: Thrombocytes

Time frame:Week 0, Week 26 and Week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematology: Erythrocytes

Time frame:Week 0, Week 26 and Week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematology: Leukocytes

Time frame:Week 0, Week 26 and Week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematology: Eosinophils

Time frame:Week 0, Week 26 and Week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematology: Neutrophils

Time frame:Week 0, Week 26 and Week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematology: Basophils

Time frame:Week 0, Week 26 and Week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematology: Monocytes

Time frame:Week 0, Week 26 and Week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematology: Lymphocytes

Time frame:Week 0, Week 26 and Week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change in Calcitonin

Time frame:Week 0 and Week 26 and Week 52

Thyroid event

categorical status, event

Other clinical outcomes

2 endpoints

Secondary/registry result

Change in Eye Examination

Time frame:Week 0 and Week 26 and Week 52

categorical status, descriptive

Posted result

Group	Participants	95% CI
Liraglutide 1.8 mgWeek 0: Left eye - Normal	183	-
Week 0: Left eye - Abnormal, NCS	15	-
Week 0: Left eye - Abnormal, CS	35	-
Week 26: Left eye - Normal	178	-
Week 26: Left eye - Abnormal, NCS	18	-
Week 26: Left eye - Abnormal, CS	37	-
Week 52: Left eye - Normal	181	-
Week 52: Left eye - Abnormal, NCS	16	-
Week 52: Left eye - Abnormal, CS	36	-
Week 0: Right eye - Normal	183	-
Week 0: Right eye - Abnormal, NCS	14	-
Week 0: Right eye - Abnormal, CS	36	-
Week 26: Right eye - Normal	176	-
Week 26: Right eye - Abnormal, NCS	19	-
Week 26: Right eye - Abnormal, CS	38	-
Week 52: Right eye - Normal	177	-
Week 52: Right eye - Abnormal, NCS	18	-
Week 52: Right eye - Abnormal, CS	38	-
Liraglutide 0.9 mgWeek 0: Left eye - Normal	176	-
Week 0: Left eye - Abnormal, NCS	13	-
Week 0: Left eye - Abnormal, CS	44	-
Week 26: Left eye - Normal	178	-
Week 26: Left eye - Abnormal, NCS	15	-
Week 26: Left eye - Abnormal, CS	40	-
Week 0: Right eye - Normal	180	-
Week 0: Right eye - Abnormal, NCS	11	-
Week 0: Right eye - Abnormal, CS	42	-
Week 26: Right eye - Normal	180	-
Week 26: Right eye - Abnormal, NCS	14	-
Week 26: Right eye - Abnormal, CS	39	-

Secondary/protocol endpoint

Change in Eye Examination

Time frame:Week 0 and Week 26 and Week 52

categorical status, improvement

Other (unclassified)

6 endpoints

Secondary/protocol endpoint/low confidence

Fasting Glucagon

Time frame:Week 26 and Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Biochemistry: Sodium

Time frame:Week 0, Week 26, Week 52

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Biochemistry: Albumin

Time frame:Week 0, Week 26, Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Biochemistry: Total Bilirubin

Time frame:Week 0, Week 26, Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Biochemistry: Albumin Corrected Calcium

Time frame:Week 0, Week 26, Week 52

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Haematology: Haematocrit

Time frame:Week 0, Week 26, Week 52

change from baseline, descriptive

Publications (1)

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

A randomized trial to investigate the efficacy and safety of once-daily liraglutide 1.8 mg in Japanese adults with type 2 diabetes exhibiting an inadequate response to liraglutide 0.9 mg.
Journal of diabetes investigation2022 Aug (month)PMID35285173doi:10.1111/jdi.13789via pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.