Immunosafety Study of Recombinant Human Insulins in Type 1 Diabetics

PHASE3TerminatedINTERVENTIONAL
Enrollment

134

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Type I Diabetes
Interventions
BIOLOGICAL

Wosulin (N or 70/30 with R)

Basal bolus conventional Insulin viz. Wosulin (N or 70/30 with R) to be injected subcutaneously.

BIOLOGICAL

Novolin® (N or 70/30 with R)

Basal bolus conventional Insulin viz. Novolin® (N or 70/30 with R) to be injected subcutaneously.

Trial Locations (25)

20852

Endocrine & Metabolic Consultants, Rockville

32174

Ormond Medical Arts Pharmaceutical Research Center, Ormond Beach

32771

International Clinical Research - US, LLC, Sanford

33012

International Research Associates, Hialeah

33021

The Center for Diabetes and Endocrine Care, Hollywood

33156

Baptist Diabetes Associates, PA, Miami

34652

Suncoast Clinical Research, New Port Richey

34684

Suncoast Clinical Research, Palm Harbor

37411

University Diabetes & Endocrine Association, Chattanooga

40503

Kentucky Diabetes Endocrinology Center, Lexington

48124

Alzohaili Medical Consultants, Dearborn

66606

Cotton-O'Neil Clinical Research Center, Diabetes & Endocrinology, Topeka

79925

Sergio Rovner, MD, El Paso

84102

Optimum Clinical Research, Inc., Salt Lake City

92780

University Clinical Investigators, Inc. dba Diabetes Research Center, Tustin

132001

Dr Sanjay Kalra, Karnāl

302006

Diabetes Thyroid &Endocrine Centre, Jaipur

302015

Bhandari's Clinic, Jaipur

380015

Dia Care - A Complete Diabetes Care Centre, Ahmedabad

440012

Dr Sharad Pendsey, Nagpur

500012

Dr Rakesh Sahay, Hyderabad

560003

Dr Mala Dharmalingam, Bangalore

560052

Bangalore Diabetes Hospital, Bangalore

01830

ActivMed Practices and Research, Haverhill

03867

ActivMed Practices and Research, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Wockhardt

INDUSTRY