Impact of Liraglutide on Endothelial Function and Microvascular Blood Flow in Type 2 Diabetes Mellitus

NCT01208012 | Completed Phase 4

• 1 other identifier: Lira-Vasc-001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The trial is a phase IV clinical trial investigating the impact of Liraglutide on endothelial function and microvascular blood flow in 44 patients with type 2 diabetes mellitus aged 30-65 and HbA1c ranging from ≥ 5.5% ≤ 7.0%. The patients will be randomized into two study arms, one arm will be treated with Metformin monotherapy, the second arm will be treated with Metformin and Liraglutide at an increasing dose (0.6 mg/day to 1.8 mg/day.)

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus treatment Metformin

Outcome Measures

Primary Outcomes (1)

• The difference in increase of retinal blood flow after flicker stimulation of retinal endothelial cells

  Retinal capillary blood flow will be assessed using scanner laser doppler flowmetry.

  timepoint 0 and after 6 and 12 weeks

Secondary Outcomes (9)

• Central vascular elasticity

  timepoint 0 and after 6 and 12 weeks

• Skin endothelial function and Skin oxygenation

  timepoint 0 and after 6 and 12 weeks

• Blood glucose control

  timepoint 0 and after 6 and 12 weeks

• Blood glucose control

  up to 2 weeks before baseline and after 6 and 12 weeks after baseline

• Change of biomarkers of sub-clinical inflammation and cardiovascular risk

  timepoint 0 and after 6 and 12 weeks

Study Arms (2)

Metformin

NO INTERVENTION

Patients taking Metformin at individual dose

Metformin and Liraglutide

EXPERIMENTAL

Patients taking Metformin at individual dose and Liraglutide 0.6 mg once daily for the 1st week, 1.2 mg daily for another 5 weeks, 1.8 mg daily for another 6 weeks.

Drug: Victoza®

Interventions

Victoza® DRUG

Patients taking Metformin at individual dose and Liraglutide 0.6 mg once daily for the 1st week, 1.2 mg daily for another 5 weeks, 1.8 mg daily for another 6 weeks. When arrived at the dosage of 1.8 mg daily and the dose is not tolerated by the patient, the dose of Liraglutide can be decreased.Liraglutide is injected in the subcutaneous tissue once daily

Also known as: Victoza®, Liraglutide

Metformin and Liraglutide

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes Mellitus type 2
• HbA1c ≥ 5.5% and ≤ 7.0%
• Treatment with Metformin (daily dose 500 - 3000 mg monotherapy, the past 3 months)
• Age 30 - 65 years

You may not qualify if:

• Pre-treatment with PPAR gamma agonists or DPP IV inhibitors or GLP-1 analogues within the last three months
• History of type 1 Diabetes Mellitus
• No full legal mental and physical ability to give informed consent
• Uncontrolled hypertension (systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 90 mmHg)
• Anamnestic acute and chronic infections
• Inflammatory bowel disease and/or diabetic gastroparesis
• Anamnestic history of epilepsy
• Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
• History of severe or multiple allergies
• Treatment with any other investigational drug within 3 months before trial entry
• Progressive fatal disease
• History of drug or alcohol abuse in the past 2 years
• Liver disease with ASAT or ALAT above 3 times the upper normal limit
• Serum potassium \> 5.5 mmol/L
• Moderate to Severe Kidney disease with a GFR ≤ 60 ml/min

Sponsors & Collaborators

• ikfe-CRO GmbH: lead
• Novo Nordisk A/S: collaborator
• IKFE Institute for Clinical Research and Development: collaborator

Study Sites (1)

IKFE Institute for Clinical Research and Development

Mainz, 55116, Germany

Location

Related Publications (1)

• Forst T, Michelson G, Ratter F, Weber MM, Anders S, Mitry M, Wilhelm B, Pfutzner A. Addition of liraglutide in patients with Type 2 diabetes well controlled on metformin monotherapy improves several markers of vascular function. Diabet Med. 2012 Sep;29(9):1115-8. doi: 10.1111/j.1464-5491.2012.03589.x.

  PMID: 22288732 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; 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

Study Officials

• Thomas Forst, Prof. Dr.

  Ikfe GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 17, 2010
• First Posted: September 23, 2010
• Study Start: April 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: March 15, 2011

Record last verified: 2011-03

Locations

DE (1)