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

January 25, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lira 1.8
Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
Drug: liraglutide
Stepwise dose increase, s.c. (under the skin) injection, once daily
Placebo Comparator: Placebo
Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
Drug: placebo
Liraglutide placebo, stepwise dose increase, s.c. (under the skin) injection, once daily
Active Comparator: Glimepiride
Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
Drug: glimepiride
Tablets, 1 - 4 mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)
Time Frame: week 0, week 12
Assessed endothelial function by measuring the change in ACh-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.
week 0, week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF)
Time Frame: week 0, week 12
Assessed endothelial function by measuring the change in SNP-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.
week 0, week 12
Change in HbA1c (Glycosylated Haemoglobin A1c)
Time Frame: week 0, week 12
Percentage point change in HbA1c
week 0, week 12
Change in Fasting Plasma Glucose (FPG)
Time Frame: week 0, week 12
Change in FPG
week 0, week 12
Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles
Time Frame: week 0, week 12
The 7-point profile included plasma glucose measurements at the following time points: before each main meal (breakfast, lunch and dinner), 90 minutes after the start of each main meal (breakfast, lunch and dinner) and at bedtime.
week 0, week 12
Change in Body Weight
Time Frame: week 0, week 12
week 0, week 12
Fasting Lipid Profile - Change in Total Cholesterol (TC)
Time Frame: week 0, week 12
Change in TC
week 0, week 12
Fasting Lipid Profile - Change in LDL-C
Time Frame: week 0, week 12
Change in LDL-C
week 0, week 12
Fasting Lipid Profile - Change in HDL-C
Time Frame: week 0, week 12
Change in HDL-C
week 0, week 12
Fasting Lipid Profile - Change in Triglycerides (TG)
Time Frame: week 0, week 12
Change in TG
week 0, week 12
Biomarkers of Cardiovascular Risk - Change in TNF-alpha
Time Frame: week 0, week 12
Change in TNF-alpha
week 0, week 12
Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range
Time Frame: week 0, week 12
Number of subjects with serum BUN values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 6.000 mg/dL, upper value 21.000 mg/dL) Male (lower value 8.000 mg/dL, upper value 25.000 mg/dL).
week 0, week 12
Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range
Time Frame: week 0, week 12
Number of subjects with serum creatinine values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 0.600 mg/dL, upper value 1.100 mg/dL) Male (lower value 0.800 mg/dL, upper value 1.300 mg/dL).
week 0, week 12
Number of Hypoglycaemic Episodes
Time Frame: weeks 0-12
Total number of hypoglycaemic episodes occurring from week 0 to week 12. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself and either plasma glucose was below 56 mg/dL or symptoms were reversed after food intake or glucagon/intravenous glucose administration. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.
weeks 0-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

February 11, 2008

First Submitted That Met QC Criteria

February 20, 2008

First Posted (Estimate)

February 21, 2008

Study Record Updates

Last Update Posted (Actual)

March 8, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-1799

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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