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Safety and Tolerability of BVS857 in Subjects With Insulin Resistance

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ClinicalTrials.gov Identifier: NCT01435330
Recruitment Status : Completed
First Posted : September 16, 2011
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The study will assess the safety, tolerability, drug label and effect in subjects with and without insulin resistance.

Condition or disease Intervention/treatment Phase
Insulin Resistance Drug: BVS857 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Parenterally Administered BVS857 in Healthy Subjects Without and With Insulin Resistance
Study Start Date : March 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: BVS857 Drug: BVS857
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Blood glucose [ Time Frame: Continuously up to 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female subjects with insulin resistance
  • Subjects with controlled hypertension and hyperlipidemia

Exclusion Criteria:

  • Smokers
  • History of drug or alcohol use
  • Autonomic dysfunction
  • Significant illness or cardiovascular disease
  • Immunodeficiency disease

Other protocol-defined inclusion/exclusion criteria may apply


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 ClinicalTrials.gov identifier (NCT number): NCT01435330


Locations
United States, California
Novartis Investigative Site
Chula Vista, California, United States, 91910
United States, Washington
Novartis Investigative Site
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01435330     History of Changes
Other Study ID Numbers: CBVS857X2101
First Posted: September 16, 2011    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Safety
BVS857
insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs