Effectiveness of V-Go™ for Patients With Diabetes in a Real-world Setting

Summary

The aim of the present study is to observe glycemic control, dose requirements, hypoglycemia risk, other possible adverse effects and weight changes, as well as to compare these parameters to prior treatment when patients with type 2 diabetes are initiated and treated using V-Go during circumstances as close to normal clinical practice as possible.

Conditions

• Type 2 Diabetes Mellitus

Interventions

DEVICE

V-Go™

Use of Insulin Delivery Device, V-Go, and the effect on A1C for T2DM patients in five categories of baseline oral antidiabetes drug (OAD) use with or without insulin.

Sponsors & Collaborators

• Integrated Medical Development

  collaborator INDUSTRY

• Valeritas, Inc.

  lead INDUSTRY

Principal Investigators

• Nancy J. Bohannon, MD · Nancy J. Bohannon Med. Corp

• David Huffman, MD · University Diabetes & Endocrine Consultants

• George Grunberger, MD · Grunberger Diabetes Institute

• Kenneth Hershon, MD · North Shore Diabetes & Endocrine Assoc.

• Chip Reed, MD · Endocrine Research Solutions, Inc.

• Cheryl Rosenfeld, DO · North Jersey Endocrine Consultants, LLCAND

• Alan B. Schorr, DO · Alan B. Schorr, DO FACE

• Mark Warren, MD · Physicians East, PA

• Richard A. Guthrie, MD · MidAmerica Diabetes Associates

• Lenita Hanson, MD · MEDSOL Clinical Research Center

• Philip A. Levin, MD · MODEL Clinical Research

• Michael Shanik, MD · Endocrine Associates of Long Island, PC

• Kathryn Jean Lucas, MD · Diabetes & Endocrinology Consultants

• Mary Katherine Lawrence, MD · Down East Medical Associates

• Sherry Sussman, MD · Middle Country Endocrinology, P.C.

• Robert Bernstein, MD · Regional Endocrinology Associates, PC

• Albert Johary, MD · Albert Johary M.D., P.C.

• Jeffrey Rothman, MD · University Physicians Group

• Robert Savino, DO · Western Connecticut Health Network, Inc.

• Sarah Khan, MD · Parsippany Endocrine, LLC

• Jonathan Wilson, DO · PMG Research of Winston-Salem

• Stephanie Powell, MD · PMG Research of Bristol

• Rickey Manning, MD · PMG Research of Knoxville

• Georges M. Argoud, MD · San Diego Coastal Endocrinology Group

Eligibility

Min Age

21 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2014-03-31

Completion

2014-05-31

Countries

• United States

Study Locations