Expired Study
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Rochester, Minnesota 55905


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.


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


Study is Available At:


Original ID:

NN2211-1799


NCT ID:

NCT00620282


Secondary ID:


Study Acronym:


Brief Title:

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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

40 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novo Nordisk


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

49


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jason Brett, MD
Study Director
Novo Nordisk

Study Dates

Start Date:February 2008
Completion Date:May 2010
Completion Type:Actual
Primary Completion Date:May 2010
Primary Completion Type:Actual
Verification Date:June 2011
Last Changed Date:June 16, 2011
First Received Date:February 11, 2008
First Results Date:May 19, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Number of Hypoglycaemic Episodes
Time Frame:weeks 0-12
Safety Issues:True
Description: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 w
Outcome Type:Secondary Outcome
Measure:Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range
Time Frame:week 0, week 12
Safety Issues:True
Description: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).
Outcome Type:Secondary Outcome
Measure:Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range
Time Frame:week 0, week 12
Safety Issues:True
Description: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).
Outcome Type:Secondary Outcome
Measure:Biomarkers of Cardiovascular Risk - Change in TNF-alpha
Time Frame:week 0, week 12
Safety Issues:False
Description:Change in TNF-alpha
Outcome Type:Secondary Outcome
Measure:Fasting Lipid Profile - Change in Triglycerides (TG)
Time Frame:week 0, week 12
Safety Issues:False
Description:Change in TG
Outcome Type:Secondary Outcome
Measure:Fasting Lipid Profile - Change in HDL-C
Time Frame:week 0, week 12
Safety Issues:False
Description:Change in HDL-C
Outcome Type:Secondary Outcome
Measure:Fasting Lipid Profile - Change in LDL-C
Time Frame:week 0, week 12
Safety Issues:False
Description:Change in LDL-C
Outcome Type:Secondary Outcome
Measure:Fasting Lipid Profile - Change in Total Cholesterol (TC)
Time Frame:week 0, week 12
Safety Issues:False
Description:Change in TC
Outcome Type:Secondary Outcome
Measure:Change in Body Weight
Time Frame:week 0, week 12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles
Time Frame:week 0, week 12
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Change in Fasting Plasma Glucose (FPG)
Time Frame:week 0, week 12
Safety Issues:False
Description:Change in FPG
Outcome Type:Secondary Outcome
Measure:Change in HbA1c (Glycosylated Haemoglobin A1c)
Time Frame:week 0, week 12
Safety Issues:False
Description:Percentage point change in HbA1c
Outcome Type:Secondary Outcome
Measure:Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF)
Time Frame:week 0, week 12
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)
Time Frame:week 0, week 12
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Drug
Name:liraglutide
Description:Stepwise dose increase, s.c. (under the skin) injection, once daily
Arm Name:Lira 1.8
Intervention Type:Drug
Name:placebo
Description:Liraglutide placebo, stepwise dose increase, s.c. (under the skin) injection, once daily
Arm Name:Placebo
Intervention Type:Drug
Name:glimepiride
Description:Tablets, 1 - 4 mg daily
Arm Name:Glimepiride

Study Arms

Study Arm Type:Active Comparator
Arm Name:Glimepiride
Description:Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
Study Arm Type:Experimental
Arm Name:Lira 1.8
Description: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)

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novo Nordisk

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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