Safety and Tolerability of BVS857 in Subjects With Insulin Resistance

Phase 1

Completed

• Conditions: Insulin Resistance
• Interventions: Drug: BVS857; Drug: Placebo

• Registration Number: NCT01435330
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-09-14
• Study First Submitted QC: 2011-09-15
• Study First Posted: 2011-09-16
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-23
• Last Update Posted: 2015-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BVS857	BVS857	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Blood glucose	Continuously up to 48 hours

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 Tacoma, Washington, United States