CompletedPhase 1

Safety and Tolerability of Liraglutide in Japanese Subjects With Type 2 Diabetes

A Randomised, Double-blind Within Dose Group, Single-centre, Placebo-controlled, Parallel 2-different Dose Group, 14-day Multiple s.c. Doses Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Liraglutide (NNC 90-1170) in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

•BMI 18.5-30•HbA1c 6-9%

Primary endpoints

•Thyroid event•24-hour profiles of Ca2+ (ionised calcium)•24-hour profiles of PTH (Parathyroid Hormone)

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 IDNCT01615978

Org study IDNN2211-1591

Timeline

Milestones

Study first posted2012-06-11estimated

Last update posted2017-01-25estimated

Study start2003-12 (month precision)

Primary completion2004-03actual (month precision)

Study completion2004-03actual (month precision)

Assets

Investigational agents

Liraglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age20 Years

Maximum age64 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes

•Duration of diabetes for more than 12 weeks

•Subjects currently on diet therapy (OHA-naïve) or treated with OHA (oral hypoglycaemic agent)

•monotherapy for more than 12 weeks

•HbA1c (Glycated haemoglobin A1c) between 6.0-9.0 %, both inclusive

•Body Mass Index (BMI): 18.5-30.0 kg/m^2

Exclusion criteria

•Recurrent severe hypoglycaemia

•Proliferative retinopathy or maculopathy requiring acute treatment

•Impaired hepatic function

•Impaired renal function

•Cardiac problems

•Uncontrolled treated/untreated hypertension

•Current treatment with insulin preparations or TZDs (thiazolidinediones)

•Current treatment or expected at the screening to start treatment with systemic corticosteroids

Endpoints (11)

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

Other (unclassified)

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint/low confidence

24-hour profiles of serum insulin

descriptive

Secondary/protocol endpoint

24-hour profiles of plasma glucose

descriptive

Safety / tolerability / PK

7 endpoints

Primary/protocol endpoint

24-hour profiles of serum calcitonin

Thyroid event

concentration, descriptive

Primary/protocol endpoint

Adverse events

Treatment-emergent AEs (any)

descriptive, event

Secondary/protocol endpoint

Area under the plasma liraglutide curve

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Cmax, maximum plasma liraglutide concentration

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax, time to reach Cmax

Tmax

descriptive

Secondary/protocol endpoint

Terminal phase elimination rate-constant

descriptive

Secondary/protocol endpoint

t½, terminal elimination half life

Half-life

descriptive

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

24-hour profiles of Ca2+ (ionised calcium)

descriptive

Primary/protocol endpoint/low confidence

24-hour profiles of PTH (Parathyroid Hormone)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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.