Back to resultsSafety and Tolerability of Liraglutide in Japanese Subjects With Type 2 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
liraglutide
liraglutide
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Fixed dose: 5 mcg/kg
Escalated dose: 10 mcg/kg
Arm Description
Outcomes
Primary Outcome Measures
24-hour profiles of serum calcitonin
24-hour profiles of Ca2+ (ionised calcium)
24-hour profiles of PTH (Parathyroid Hormone)
Adverse events
Secondary Outcome Measures
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
24-hour profiles of serum insulin
24-hour profiles of plasma glucose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01615978
Brief Title
Safety and Tolerability of Liraglutide in Japanese Subjects With Type 2 Diabetes
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
March 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fixed dose: 5 mcg/kg
Arm Type
Experimental
Arm Title
Escalated dose: 10 mcg/kg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
5 mcg/kg daily for 14 days. Injected subcutaneously once daily
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
Initial dose of 5 mcg/kg for 7 days followed by 10 mcg/kg for 7 days. Injected subcutaneously once daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1
Primary Outcome Measure Information:
Title
24-hour profiles of serum calcitonin
Title
24-hour profiles of Ca2+ (ionised calcium)
Title
24-hour profiles of PTH (Parathyroid Hormone)
Title
Adverse events
Secondary Outcome Measure Information:
Title
Area under the plasma liraglutide curve
Title
Cmax, maximum plasma liraglutide concentration
Title
tmax, time to reach Cmax
Title
Terminal phase elimination rate-constant
Title
t½, terminal elimination half life
Title
24-hour profiles of serum insulin
Title
24-hour profiles of plasma glucose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
1000005
Country
Japan
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Safety and Tolerability of Liraglutide in Japanese Subjects With Type 2 Diabetes
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