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The Vascular Effects of Vildagliptin in Insulin Resistant Individuals

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Royal Devon and Exeter NHS Foundation Trust.
Recruitment status was:  Recruiting
National Institute for Health Research, United Kingdom
Novartis Pharmaceuticals
Information provided by:
Royal Devon and Exeter NHS Foundation Trust Identifier:
First received: May 12, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted

Animal models have demonstrated that incretins have a glucose-independent effect on vascular perfusion, and there is limited evidence that incretins may enhance endothelial function in healthy subjects. Currently DPP-4 inhibition increases levels of the endogenous incretin Glucagon-like Peptide 1 (GLP-1) and is licensed for the treatment of hyperglycaemia in type 2 diabetes. They are positioned as third or even fourth line therapy after metformin, sulphonylureas ± glitazones, however recent analyses of cardiovascular outcomes in glitazones and sulphonylureas suggest at best they do not reduce cardiovascular endpoints, and may increase some outcomes. If the vascular benefits suggested in animal models are realised in humans this should see the DPP-4 inhibitors moved to second line and possibly 1st line.

In order to realise the potential the investigators would like initially to demonstrate increases in vascular perfusion and function in a placebo controlled trial using accurate surrogates for vascular function in patients with insulin resistance and obesity.

The investigators hypothesis is that by increasing incretin activity in insulin resistant states the investigators will lower capillary pressure and improve microvascular function, which will be accompanied by a reduction in macular thickness (by reducing macular oedema) and microalbuminuria, recognised surrogates for early diabetic retinopathy and renal failure respectively.

Condition Intervention Phase
Insulin Resistance
Microvascular Disease
Drug: Vildagliptin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Modulating the Gut Hormones, Incretins, Modify Vascular Function, Thereby Reducing the Risk of Vascular Complications in Insulin Resistant Individuals?

Further study details as provided by Royal Devon and Exeter NHS Foundation Trust:

Primary Outcome Measures:
  • Capillary pressure [ Time Frame: 3 months ]
    Capillary pressure will be reduced in those treated with DPP-4 inhibitor

Secondary Outcome Measures:
  • Macular thickness [ Time Frame: 3 months ]
    Measured by optical coherence tomography

Estimated Enrollment: 15
Study Start Date: May 2010
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Matched tablets
Experimental: Vildagliptin
Vildagliptin 50mg bid
Drug: Vildagliptin
Vildagliptin 50mg bid
Other Name: Galvus

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Obese (BMI >30)
  • High FinRisk score

Exclusion Criteria:

  • Diabetes
  • Overt cardiovascular disease
  • Raynauds disease
  • Current treatment with any anti-hypertensive, oral hypoglycaemic or lipid lowering therapies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01122641

Contact: David Strain, MD MRCP 01392 403058

United Kingdom
Diabetes and Vascular Research Department Recruiting
Exeter, Devon, United Kingdom, EX2 5AX
Contact: David Strain    01392 403058   
Principal Investigator: Kim Gooding, PhD         
Sponsors and Collaborators
Royal Devon and Exeter NHS Foundation Trust
National Institute for Health Research, United Kingdom
Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Dr David Strain, Institute of Biomedical and Clinical Science, Peninsula Medical School Identifier: NCT01122641     History of Changes
Other Study ID Numbers: 2009-013100-32  09/H0206/33 
Study First Received: May 12, 2010
Last Updated: May 12, 2010

Keywords provided by Royal Devon and Exeter NHS Foundation Trust:
Insulin resistance
DPP4 inhibitors

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on February 27, 2017