A Trial to Assess the Effect of Liraglutide on Blood Triglyceride (Fat) Levels After a Meal in Type 2 Diabetics
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00993304
First received: October 9, 2009
Last updated: June 19, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: liraglutide Drug: placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Trial to Assess the Effect of Liraglutide on Postprandial Triglyceride Levels in Subjects With Type 2 Diabetes |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Glucose, insulin, C-peptide and glucagon: AUC0-8 hours after meal with a high fat content [ Time Frame: after 3 weeks of treatment ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | October 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
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 Comparator: B |
Drug: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00993304 History of Changes |
| Other Study ID Numbers: | NN2211-3534, 2008-003229-18, U1111-1111-9161 |
| Study First Received: | October 9, 2009 |
| Last Updated: | June 19, 2012 |
| Health Authority: | Denmark: Danish Medicines Agency Germany: Federal Institute for Drugs and Medicinal Devices (BfarM) |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glucagon-Like Peptide 1 |
Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013