The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00620282

Purpose

This trial is conducted in the United States of America (USA). The purpose of the trial is to assess the effect of liraglutide on forearm blood flow in subjects with type 2 diabetes who are on diet and lifestyle changes or treated with metformin alone

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: liraglutide Drug: placebo Drug: glimepiride	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Liraglutide Glimepiride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

ACh-mediated forearm blood flow (FBF) [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

SNP-mediated FBF [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
FPG [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
7-point plasma glucose profiles (self-measured) [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Body weight [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Fasting lipid profile [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Biomarkers of cardiovascular risk [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
Incidence of hypoglycaemic episodes [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
Haematology and biochemistry tests [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]

Estimated Enrollment:	54
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: liraglutide Stepwise dose increase, s.c. injection, once daily
B: Experimental	Drug: placebo Liraglutide placebo, stepwise dose increase, s.c. injection, once daily
C: Active Comparator	Drug: glimepiride Tablets, 1 - 4 mg daily

Eligibility

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes
Diet and lifestyle changes or metformin monotherapy for at least three months
HbA1c 6.5-9.0% (both inclusive)
BMI less than or equal to 40 kg/m2

Exclusion Criteria:

Previous treatment with insulin (except for short term treatment with insulin in connection with intercurrent illness, at the discretion of the Investigator
Previous treatment with GLP-1 analogues/mimetics, including treatment in a clinical trial
Treatment with any oral hypoglycaemic agents other than metformin in a period of 3 months prior to screening
Current smoker or history of smoking within 6 months prior to screening
Evidence of overt cardiovascular disease (documented coronary heart disease, class II-IV congestive heart failure, cerebrovascular disease, or peripheral vascular disease)
Abnormal, clinically significant exercise stress ECG test, as judged by the Investigator
Known retinopathy or maculopathy requiring acute treatment, as judged by the Investigator
Known autonomic neuropathy, as judged by the Investigator
Initiation or change (dose or treatment regimen) in concomitant blood pressure-lowering or lipid-lowering medication within 4 weeks prior to screening
Systolic blood pressure more than or equal to 140 mmHg and/or diastolic blood pressure more than or equal to 90 mmHg

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620282

Contacts

Contact: Novo Nordisk Clinical Trial Call Center

866-867-7178

Locations

United States, Minnesota
Novo Nordisk Clinical Trial Call Center	Recruiting
Rochester, Minnesota, United States, 55905-0001

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Jason Brett, MD

Novo Nordisk

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN2211-1799
Study First Received:	February 11, 2008
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00620282
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Glimepiride
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents
Immunologic Factors
Therapeutic Uses
Physiological Effects of Drugs

Cardiovascular Agents
Anti-Arrhythmia Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009