Skip to main content
OpenTrials
Completed

NCT Number: NCT00993304

A Trial to Assess the Effect of Liraglutide on Blood Triglyceride (Fat) Levels After a Meal in Type 2 Diabetics

This trial is conducted in Europe. The aim of this trial is to investigate whether a new compound, liraglutide, reduces the level of lipids (fat), including cholesterol, in the blood of type 2 diabetics, following a meal with high fat content.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Aarhus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with type 2 diabetes mellitus (diet and exercise treated, or treated with specific oral antidiabetics (metformin, sulfonylureas and glinides) mono- or combination therapy) diagnosed at least 3 months previously
  • BMI between 18.5 and 40 kg/m2
  • HbA1c between 6.5 and 10.0% both inclusive

Exclusion criteria

  • Known or suspected allergy to trial products or related products
  • Previous participation in this trial (randomised). Re-screening of screening failures is allowed only once
  • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptives are defined as combination oral contraceptives (OC), hormonal intra uterine devices (IUDs), implants and injectables; for Germany, a condom for the male partner must be used in combination with OC, IUD, implant or injectables for the duration of the trial and for 30 days following the last dose of trial medication) if not sterile or post-menopausal
  • The receipt of any investigational drug within 3 months prior to this trial
  • Previous insulin treatment (short-term insulin treatment of up to 7 days are exempted if this has occurred no later than 3 months prior to screening).
  • Cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder (except type 2 diabetes)
  • Clinically significant active cardiovascular disease including history of myocardial infarction (heart attack) within the past 6 months and/or heart failure at the discretion of the Investigator.
  • History of alcoholism or drug abuse during the last 12 months
  • Blood donation within the last 3 months. Plasma donation within the last month.
  • Additional exclusion criteria for Germany: Male subjects who are sexually active and have partners who are or could be pregnant, not using a barrier method of contraception (e.g. condom) for the duration of the trial and for 30 days following the last dose of trial medication

Treatment and study plan

liraglutide

Drug

In the first 3-week period, the treatment will be one week with 0.6 mg, one week with 1.2 mg and one week with 1.8 mg liraglutide. Subsequently, a wash-out period of 3 to 9 weeks occurs and then a second period of 3 weeks' treatment with placebo. At the end of each of the 2 treatment periods, a high fat meal test will be performed.

Placebo

Drug

In the first 3-week period, the treatment will be with placebo. Subsequently, a wash-out period of 3 to 9 weeks occurs and then a second period of one week with 0.6 mg, one week with 1.2 mg and one week with 1.8 mg of liraglutide. At the end of each of the 2 treatment periods, a high fat meal test will be performed.

Primary outcomes

  1. AUC0-8h (triglyceride), the area under the triglyceride-concentration-time curve in the interval 0-8 hours following a meal with a high fat content

    Time frame: after 3 weeks of treatment

Secondary outcomes

  1. FFA (Free Fatty Acid), VLDL (Very Low Density), and apoB48: AUC0-8 hours after meal with a high fat content

    Time frame: after 3 weeks of treatment

  2. Glucose, insulin, C-peptide and glucagon: AUC0-8 hours after meal with a high fat content

    Time frame: after 3 weeks of treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Trial to Assess the Effect of Liraglutide on Postprandial Triglyceride Levels in Subjects With Type 2 Diabetes

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 12, 2009
Registry last updated
Jan 26, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.