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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615978
• Other study ID #: NN2211-1591
• Status: Completed
• Phase: Phase 1
• First received: June 7, 2012
• Last updated: January 24, 2017
• Start date: December 2003
• Est. completion date: March 2004

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
5 mcg/kg daily for 14 days. Injected subcutaneously once daily
• liraglutide
Initial dose of 5 mcg/kg for 7 days followed by 10 mcg/kg for 7 days. Injected subcutaneously once daily
• placebo
Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

References & 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. End

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour profiles of serum calcitonin
Primary	24-hour profiles of Ca2+ (ionised calcium)
Primary	24-hour profiles of PTH (Parathyroid Hormone)
Primary	Adverse events
Secondary	Area under the plasma liraglutide curve
Secondary	Cmax, maximum plasma liraglutide concentration
Secondary	tmax, time to reach Cmax
Secondary	Terminal phase elimination rate-constant
Secondary	t½, terminal elimination half life
Secondary	24-hour profiles of serum insulin
Secondary	24-hour profiles of plasma glucose

External Links

•   Clinical Trials at Novo Nordisk