The Vascular Effects of Vildagliptin in Insulin Resistant Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01122641
Recruitment Status : Completed
First Posted : May 13, 2010
Last Update Posted : April 25, 2017
National Institute for Health Research, United Kingdom
Novartis Pharmaceuticals
Information provided by (Responsible Party):
David Strain, Royal Devon and Exeter NHS Foundation Trust

Brief Summary:

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 or disease Intervention/treatment Phase
Insulin Resistance Microvascular Disease Drug: Vildagliptin Drug: Placebo Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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?
Study Start Date : May 2010
Actual Primary Completion Date : August 1, 2014
Actual Study Completion Date : August 1, 2014

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Matched tablets
Experimental: Vildagliptin
Vildagliptin 50mg bid
Drug: Vildagliptin
Vildagliptin 50mg bid
Other Name: Galvus

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01122641

United Kingdom
Diabetes and Vascular Research Department
Exeter, Devon, United Kingdom, EX2 5AX
Sponsors and Collaborators
Royal Devon and Exeter NHS Foundation Trust
National Institute for Health Research, United Kingdom
Novartis Pharmaceuticals

Responsible Party: David Strain, PI, Royal Devon and Exeter NHS Foundation Trust Identifier: NCT01122641     History of Changes
Other Study ID Numbers: 2009-013100-32
09/H0206/33 ( Other Identifier: REC study number )
First Posted: May 13, 2010    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by David Strain, 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
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists