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The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes; Diabetes Mellitus, Type 2

Intervention: liraglutide (Drug); placebo (Drug); glimepiride (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Global Clinical Registry (GCR, 1452), Study Director, Affiliation: Novo Nordisk A/S

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)

Secondary outcome:

Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF)

Change in HbA1c (Glycosylated Haemoglobin A1c)

Change in Fasting Plasma Glucose (FPG)

Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles

Change in Body Weight

Fasting Lipid Profile - Change in Total Cholesterol (TC)

Fasting Lipid Profile - Change in LDL-C

Fasting Lipid Profile - Change in HDL-C

Fasting Lipid Profile - Change in Triglycerides (TG)

Biomarkers of Cardiovascular Risk - Change in TNF-alpha

Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range

Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range

Number of Hypoglycaemic Episodes

Eligibility

Minimum age: 40 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Novo Nordisk Clinical Trial Call Center, Rochester, Minnesota 55905, United States
Additional Information

Clinical Trials at Novo Nordisk

Starting date: February 2008
Last updated: October 29, 2014

Page last updated: August 23, 2015

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