Safety and Tolerability of Liraglutide in Japanese Subjec... | NCT01615978

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

NCT01615978

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Jan 25, 2017Estimated

Enrollment

15Actual

Phase

Phase 1

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

liraglutide
liraglutide
placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

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

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2003

Primary Completion Date

Mar 2004Actual

Completion Date

Mar 2004Actual

First Submitted Date

Jun 7, 2012

First Submission Date that Met QC Criteria

Jun 7, 2012

First Posted Date

Jun 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2017

Last Update Posted Date

Jan 25, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fixed dose: 5 mcg/kg	Experimental		Drug: liraglutide Drug: placebo
Escalated dose: 10 mcg/kg	Experimental		Drug: liraglutide Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
liraglutide	Drug	5 mcg/kg daily for 14 days. Injected subcutaneously once daily	Fixed dose: 5 mcg/kg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
24-hour profiles of serum calcitonin
24-hour profiles of Ca2+ (ionised calcium)
24-hour profiles of PTH (Parathyroid Hormone)
Adverse events

Secondary Outcomes

Measure	Description	Time Frame
Area under the plasma liraglutide curve
Cmax, maximum plasma liraglutide concentration
tmax, time to reach Cmax

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Tokyo		1000005	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	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

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D052216	Glucagon-Like Peptide 1
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2