Clinical trial NCT00620282: The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
Official title: The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus: A 12-week Randomized, Double-blind, Placebo-controlled, Parallel-group, Single-center Trial With an Open-label Glimepiride Arm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 49
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 and lifestyle changes or treated with metformin alone.


Eligibility criteria: Inclusion Criteria:

* 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 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 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

Primary outcomes:
measure: Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)
timeFrame: week 0, week 12
Secondary outcomes:
measure: Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF)
timeFrame: week 0, week 12
measure: Change in HbA1c (Glycosylated Haemoglobin A1c)
timeFrame: week 0, week 12
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: week 0, week 12
measure: Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles
timeFrame: week 0, week 12
measure: Change in Body Weight
timeFrame: week 0, week 12
measure: Fasting Lipid Profile - Change in Total Cholesterol (TC)
timeFrame: week 0, week 12
measure: Fasting Lipid Profile - Change in LDL-C
timeFrame: week 0, week 12
measure: Fasting Lipid Profile - Change in HDL-C
timeFrame: week 0, week 12
measure: Fasting Lipid Profile - Change in Triglycerides (TG)
timeFrame: week 0, week 12
measure: Biomarkers of Cardiovascular Risk - Change in TNF-alpha
timeFrame: week 0, week 12
measure: Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range
timeFrame: week 0, week 12
measure: Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range
timeFrame: week 0, week 12
measure: Number of Hypoglycaemic Episodes
timeFrame: weeks 0-12
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Novo Nordisk Investigational Site
state: Minnesota
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.
citation: Nandy D, Johnson C, Basu R, Joyner M, Brett J, Svendsen CB, Basu A. The effect of liraglutide on endothelial function in patients with type 2 diabetes. Diab Vasc Dis Res. 2014 Nov;11(6):419-30. doi: 10.1177/1479164114547358. Epub 2014 Sep 11.
citation: Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.