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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993304
• Other study ID #: NN2211-3534
• Secondary ID: 2008-003229-18U1
• Status: Completed
• Phase: Phase 1
• First received: October 9, 2009
• Last updated: January 25, 2017
• Start date: October 2009
• Est. completion date: December 2010

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
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
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.

Locations

Country	Name	City	State
Denmark	Novo Nordisk Investigational Site	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Hermansen K, Bækdal TA, Düring M, Pietraszek A, Mortensen LS, Jørgensen H, Flint A. Liraglutide suppresses postprandial triglyceride and apolipoprotein B48 elevations after a fat-rich meal in patients with type 2 diabetes: a randomized, double-blind, plac — View Citation

Røge RM, Klim S, Ingwersen SH, Kjellsson MC, Kristensen NR. The Effects of a GLP-1 Analog on Glucose Homeostasis in Type 2 Diabetes Mellitus Quantified by an Integrated Glucose Insulin Model. CPT Pharmacometrics Syst Pharmacol. 2015 Jan;4(1):e00011. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		after 3 weeks of treatment
Secondary	FFA (Free Fatty Acid), VLDL (Very Low Density), and apoB48: AUC0-8 hours after meal with a high fat content		after 3 weeks of treatment
Secondary	Glucose, insulin, C-peptide and glucagon: AUC0-8 hours after meal with a high fat content		after 3 weeks of treatment

External Links

•   Clinical Trials at Novo Nordisk