Status:
COMPLETED
The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
40-70 years
Phase:
PHASE3
Brief Summary
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 an...
Eligibility Criteria
Inclusion
- Type 2 diabetes
- Diet and lifestyle changes or metformin monotherapy for at least three months
- HbA1c (glycosylated haemoglobin) 6.5-9.0% (both inclusive)
- Body Mass Index (BMI) less than or equal to 40 kg/m\^2
Exclusion
- 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 glucagon-like peptide-1 (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 electrocardiogram (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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00620282
Start Date
February 1 2008
End Date
May 1 2010
Last Update
March 8 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Rochester, Minnesota, United States, 55905