NCT01615978

Brief Summary

This trial is conducted in Japan. The aim of this trial is to assess the safety after multiple s.c. (subcutaneously) doses of liraglutide in Japanese subjects with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 diabetes

Timeline
Completed

Started Dec 2003

Shorter than P25 for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2012

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

3 months

First QC Date

June 7, 2012

Last Update Submit

January 24, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

  • 24-hour profiles of serum calcitonin

  • 24-hour profiles of Ca2+ (ionised calcium)

  • 24-hour profiles of PTH (Parathyroid Hormone)

  • Adverse events

Secondary Outcomes (7)

  • Area under the plasma liraglutide curve

  • Cmax, maximum plasma liraglutide concentration

  • tmax, time to reach Cmax

  • Terminal phase elimination rate-constant

  • t½, terminal elimination half life

  • +2 more secondary outcomes

Study Arms (2)

Fixed dose: 5 mcg/kg

EXPERIMENTAL
Drug: liraglutideDrug: placebo

Escalated dose: 10 mcg/kg

EXPERIMENTAL
Drug: liraglutideDrug: placebo

Interventions

liraglutideDRUG

5 mcg/kg daily for 14 days. Injected subcutaneously once daily

Fixed dose: 5 mcg/kg
placeboDRUG

Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1

Escalated dose: 10 mcg/kgFixed dose: 5 mcg/kg

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Location

Related Publications (1)

  • Kageyama S, Hirao K, Shimizu A, Matsumura Y, Zdravkovic M, Rasmussen MF, Irie S. Tolerability, pharmacokinetics, and pharmacodynamics of liraglutide, long-acting human GLP-1 analogue - Phase 1 studies in Japanese healthy subjects with type 2 diabetes. Endocrinology and Diabetology 2007; 24 (6): 95-104

    RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2012

First Posted

June 11, 2012

Study Start

December 1, 2003

Primary Completion

March 1, 2004

Study Completion

March 1, 2004

Last Updated

January 25, 2017

Record last verified: 2017-01

Locations

JP(1)