DelfaGLP-1 Atlas

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CompletedPhase 3Results posted

Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Alone in Japanese Subjects With Type 2 Diabetes

A 36-week, Randomised, Multi-centre, Double-blind, Parallel Group Trial to Investigate the Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Monotherapy in Japanese Subjects With Type 2 Diabetes Mellitus

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

23

Recruiting sites

—

Enrollment

257

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤45•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 IDNCT01572740
Org study IDNN2211-3925
Secondary IDJapicCTI-121802JAPIC
Secondary IDU1111-1122-4320WHO

Timeline

Milestones

Study start2012-04-05actual
Study first posted2012-04-06estimated
Primary completion2012-11-01actual
Study completion2013-03-27actual
Results first posted2014-05-23estimated
Last update posted2018-02-07actual

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

•Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
•Current insulin therapy (basal insulin, premixed insulin or basal-bolus regimen) in addition to diet and exercise therapy for at least 12 weeks prior to trial start. Their therapy is stable and fluctuation of total daily insulin dose is within plus/minus 20% for at least 12 weeks prior to trial start and current total daily insulin dose equal to or greater than 10 (I)U/day
•Glycosylated haemoglobin (HbA1c) between 7.5 and 11.0% (both inclusive)
•Body Mass Index (BMI) below 45.0 kg/m^2

Exclusion criteria

•Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as, but not limited to systemic corticosteroids, beta-antagonists or monoamine oxidase (MAO) inhibitors
•Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode during last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
•Known proliferative retinopathy or maculopathy requiring treatment according to the investigator
•Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist within 12 weeks prior to screening
•Treatment with any oral antidiabetic drugs (OADs) within 12 weeks prior to screening

Endpoints (24)

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
16
Weight & body composition
4
Safety / tolerability / PK
4

Weight & body composition

4 endpoints
Secondary/registry result

Change in Body Weight From Baseline to Week 16

Time frame:Week 0, Week 16

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), kg95% CI
Lira + Insulin-0.42—
Placebo + Insulin-0.28—
Estimated treatment difference, Mean-0.1495% CI-0.54 – 0.25p0.4806ANCOVA
Secondary/registry result

Change in Body Weight From Baseline to Week 36

Time frame:Week 0, Week 36

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), kg95% CI
Lira + Insulin0.17—
Placebo + Insulin0.52—
Estimated treatment difference, Mean-0.3595% CI-0.91 – 0.20p0.2074ANCOVA
Secondary/protocol endpoint

Change in Body Weight From Baseline to Week 16

Time frame:Week 0, Week 16

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight From Baseline to Week 36

Time frame:Week 0, Week 36

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

16 endpoints
Primary/registry result

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16

Time frame:Week 0, Week 16

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), percentage of glycosylated haemoglobin95% CI
Lira + Insulin-1.73—
Placebo + Insulin-0.43—
Estimated treatment difference, Mean-1.3095% CI-1.47 – -1.13p<0.0001ANCOVA
Primary/protocol endpoint

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16

Time frame:Week 0, Week 16

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36

Time frame:Week 0, Week 36

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), percentage of glycosylated haemoglobin95% CI
Lira + Insulin-1.68—
Placebo + Insulin-0.88—
Estimated treatment difference, Mean-0.8195% CI-0.99 – -0.63p<0.0001ANCOVA
Secondary/registry result

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16

Time frame:Week 0, Week 16

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (mean), mmol/L95% CI
Lira + Insulin-1.31—
Placebo + Insulin-0.48—
Estimated treatment difference, Mean-0.8395% CI-1.30 – -0.36p<0.0006ANCOVA
Secondary/registry result

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36

Time frame:Week 0, Week 36

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (mean), mmol/L95% CI
Lira + Insulin-1.55—
Placebo + Insulin-1.29—
Estimated treatment difference, Mean-0.2695% CI-0.70 – 0.18p0.2511ANCOVA
Secondary/registry result

Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16

Time frame:Week 0, Week 16

Postprandial glucose

change from baseline, improvement

Posted result

GroupValue (mean), mmol/L95% CI
Lira + Insulin-2.41—
Placebo + Insulin-0.53—
Estimated treatment difference, Mean-1.8795% CI-2.37 – -1.38p<0.0001ANCOVA
Secondary/registry result

Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36

Time frame:Week 0, Week 36

Postprandial glucose

change from baseline, improvement

Posted result

GroupValue (mean), mmol/L95% CI
Lira + Insulin-2.65—
Placebo + Insulin-1.37—
Estimated treatment difference, Mean-1.2895% CI-1.73 – -0.83p<0.0001ANCOVA
Secondary/registry result

Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 16

Time frame:Week 0, Week 16

Postprandial glucose

change from baseline, improvement

Posted result

GroupValue (mean), mmol/L95% CI
Lira + Insulin-1.34—
Placebo + Insulin-0.61—
Estimated treatment difference, Mean-0.7395% CI-1.20 – -0.26p0.0023ANCOVA
Secondary/registry result

Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 36

Time frame:Week 0, Week 36

Postprandial glucose

change from baseline, improvement

Posted result

GroupValue (mean), mmol/L95% CI
Lira + Insulin-1.34—
Placebo + Insulin-0.94—
Estimated treatment difference, Mean-0.3995% CI-0.97 – 0.18p0.1787ANCOVA
Secondary/protocol endpoint

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36

Time frame:Week 0, Week 36

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16

Time frame:Week 0, Week 16

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36

Time frame:Week 0, Week 36

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16

Time frame:Week 0, Week 16

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36

Time frame:Week 0, Week 36

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 16

Time frame:Week 0, Week 16

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 36

Time frame:Week 0, Week 36

Postprandial glucose

change from baseline, improvement

Safety / tolerability / PK

4 endpoints
Secondary/registry result

Number of Adverse Events (AEs)

Time frame:Week 0 to Week 36 (inclusive)

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (number), Events/100 years of patient exposure95% CI
Lira + InsulinAdverse Events449—
Serious Adverse Events8—
Severe Adverse Events5—
Moderate Adverse Events8—
Mild Adverse Events436—
Placebo + InsulinAdverse Events350—
Serious Adverse Events5—
Severe Adverse Events1—
Moderate Adverse Events14—
Mild Adverse Events335—
Secondary/registry result

Number of Confirmed Hypoglycaemic Episodes

Time frame:Week 0 to week 36 (inclusive)

Documented hypoglycemia

event count, event

Posted result

GroupValue (number), Episodes/100 years of patient exposure95% CI
Lira + Insulin146—
Placebo + Insulin187—
Secondary/protocol endpoint

Number of Adverse Events (AEs)

Time frame:Week 0 to Week 36 (inclusive)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Confirmed Hypoglycaemic Episodes

Time frame:Week 0 to week 36 (inclusive)

Documented hypoglycemia

event count, event

Publications (2)

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

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.