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Completed

NCT Number: NCT01615978

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 24-hour profiles of serum calcitonin

  2. 24-hour profiles of Ca2+ (ionised calcium)

  3. 24-hour profiles of PTH (Parathyroid Hormone)

  4. Adverse events

Secondary outcomes

  1. Area under the plasma liraglutide curve

  2. Cmax, maximum plasma liraglutide concentration

  3. tmax, time to reach Cmax

  4. Terminal phase elimination rate-constant

  5. t½, terminal elimination half life

  6. 24-hour profiles of serum insulin

  7. 24-hour profiles of plasma glucose

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Jun 11, 2012
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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