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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620282
• Other study ID #: NN2211-1799
• Status: Completed
• Phase: Phase 3
• First received: February 11, 2008
• Last updated: October 29, 2014
• Start date: February 2008
• Est. completion date: May 2010

Study information

• Verified date: October 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
Stepwise dose increase, s.c. (under the skin) injection, once daily
• placebo
Liraglutide placebo, stepwise dose increase, s.c. (under the skin) injection, once daily
• glimepiride
Tablets, 1 - 4 mg daily

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)	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	No
Secondary	Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF)	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	No
Secondary	Change in HbA1c (Glycosylated Haemoglobin A1c)	Percentage point change in HbA1c	week 0, week 12	No
Secondary	Change in Fasting Plasma Glucose (FPG)	Change in FPG	week 0, week 12	No
Secondary	Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles	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	No
Secondary	Change in Body Weight		week 0, week 12	No
Secondary	Fasting Lipid Profile - Change in Total Cholesterol (TC)	Change in TC	week 0, week 12	No
Secondary	Fasting Lipid Profile - Change in LDL-C	Change in LDL-C	week 0, week 12	No
Secondary	Fasting Lipid Profile - Change in HDL-C	Change in HDL-C	week 0, week 12	No
Secondary	Fasting Lipid Profile - Change in Triglycerides (TG)	Change in TG	week 0, week 12	No
Secondary	Biomarkers of Cardiovascular Risk - Change in TNF-alpha	Change in TNF-alpha	week 0, week 12	No
Secondary	Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range	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	Yes
Secondary	Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range	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	Yes
Secondary	Number of Hypoglycaemic Episodes	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	Yes

External Links

•   Clinical Trials at Novo Nordisk