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

NCT00620282 | Completed Phase 3 Results

• 1 other identifier: NN2211-1799
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

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

  week 0, week 12

• Change in HbA1c (Glycosylated Haemoglobin A1c)

  week 0, week 12

• Change in Fasting Plasma Glucose (FPG)

  week 0, week 12

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

  week 0, week 12

• Change in Body Weight

  week 0, week 12

Study Arms (3)

Lira 1.8

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Glimepiride

ACTIVE COMPARATOR

Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12

Drug: glimepiride

Interventions

liraglutide DRUG

Stepwise dose increase, s.c. (under the skin) injection, once daily

Lira 1.8

placebo DRUG

Liraglutide placebo, stepwise dose increase, s.c. (under the skin) injection, once daily

Placebo

glimepiride DRUG

Tablets, 1 - 4 mg daily

Glimepiride

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Rochester, Minnesota, 55905, United States

Location

Related Publications (3)

• 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.

  PMID: 23010561 RESULT

• 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.

  PMID: 25212693 RESULT

• 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.

  PMID: 25504028 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Liraglutide; glimepiride

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Public Access to Clinical Trials
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 21, 2008
• Study Start: February 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: March 8, 2017
• Results First Posted: June 15, 2011

Record last verified: 2017-01

Locations

US (1)