Study Stopped
Business reasons
Immunosafety Study of Recombinant Human Insulins in Type 1 Diabetics
An Open Label,Randomized,Comparison of the Immunogenicity and Safety of Wockhardt's Human Insulin Basal Bolus Regimen With the Novo Nordisk's Yeast Based Human Insulin Basal Bolus Regimens, Marketed in United States, in Type 1 Diabetics.
1 other identifier
interventional
134
2 countries
25
Brief Summary
This is an open label, randomized, parallel group comparison of the immunogenicity safety of Wockhardt's human insulin and isophane insulin compared with the Novo Nordisk's yeast based human insulin products (marketed in USA) in type 1 diabetics. There are two phases of the study, which are as follows:
- 1.Phase 1 is a comparative phase in which there will be 2 arms (which are described in the section below).
- 2.Phase 2 is a follow up phase only applicable to Wosulin Arm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2011
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedFirst Posted
Study publicly available on registry
March 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJune 23, 2023
June 1, 2023
2.1 years
February 9, 2011
June 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbAlc from baseline to 6 months of treatment between Wosulin arm and Novolin arm(as surrogate indicator of change in insulin antibodies titers between the two treatment arms).
6 months
Secondary Outcomes (4)
Correlation between change in HbA1c and change in anti insulin and insulin neutralizing antibodies.
6 months and 12 months
To compare the change from baseline in the level of serum anti insulin antibodies and insulin neutralizing antibodies between the two arms
6 months
Compare the change in Insulin dose between the two arms
3 and 6 months
Correlation of the immunogenicity with hypoglycemia, local allergic reactions and systemic allergic reactions will be evaluated.
6 and 12 months
Study Arms (2)
Wosulin (N or 70/30 with R)
EXPERIMENTALBasal bolus conventional Insulin viz. Wosulin (N or 70/30 with R) to be injected subcutaneously.
Novolin® (N or 70/30 with R)
ACTIVE COMPARATORBasal bolus conventional Insulin viz. Novolin® (N or 70/30 with R) to be injected subcutaneously.
Interventions
Basal bolus conventional Insulin viz. Wosulin (N or 70/30 with R) to be injected subcutaneously.
Basal bolus conventional Insulin viz. Novolin® (N or 70/30 with R) to be injected subcutaneously.
Eligibility Criteria
You may qualify if:
- Subjects who understand the nature of the study and are willing to provide written informed consent.
- Subjects who have been on a stable regimen of recombinant human insulin or analogs for at least 3 months prior to randomization. (A stable regimen is defined as the dose within +/- 10%).
- Male or female subjects ≥ 18 and \< 55 years of age.
- Subjects with body mass index (BMI) of ≥18.0 to \< 35.0 kg/m2
- Subjects with glycosylated hemoglobin (HbA1c) levels between ≥6.5 and \< 9.5%
- Subjects who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures.
- Female subjects who are not pregnant and non-lactating with adequate protection from conception and fulfilling one of the following criteria are also eligible if within ≥ 18 and \< 55 years age limits:
- Women of childbearing potential on an acceptable method of birth control (including but not limited to barrier-method, contraceptives, or intrauterine device)
- Women with history of bilateral tubal ligation,
- Women who have undergone total hysterectomy
- Women who are two years post-menopausal
- Subjects who are able to use the self glucose-monitoring device and to self inject insulin.
You may not qualify if:
- Female subjects who are pregnant (as confirmed by a positive urine and serum β-HCG) or are currently breast-feeding.
- Compromised hepatic or renal function, as shown by but not limited to:
- i.Baseline AST or ALT \>3 times the upper limit of normal range, and/or ii.Serum Creatinine \>2.0 mg/dl and/or iii.BUN \>30 mg/dl Abnormal laboratory findings will be discussed with the medical monitor prior to the subject's entry.
- Employee of Investigator or have direct involvement with trial or other trials under the direction of Investigator.
- Those treated with other investigational agents or devices within previous 30 days, from screening, have planned use of an investigational drug or device, or have been previously randomized in this trial.
- History or evidence of allergy to insulin preparations.
- History or evidence of severe hypoglycemia (severe hypoglycemic episode defined as the subject required glucose, glucagon, orange juice etc administered by a second person)
- Requirement for total daily dose of insulin is \>1.4 units/kg
- Who have received Wockhardt's (Wosulin) or Novo Nordisk's Insulin (Novolin® R, Novolin® N, Novolin® 70/30, in US and Actrapid® Insulatard®, and Mixtard® in India) during the previous one year.
- Serum AIA level \> 20 microU/ml.
- Receipt of any insulin of an animal origin during the last 3 years.
- Currently receiving or have received within the last year any immunomodulators medications, including corticosteroids that would possibly modify antibody generation either at the enrollment or during the course of the study. (Topical/ ophthalmic/intra-articular/nasal spray corticosteroids will be allowed).
- Hepatitis B or Hepatitis C or HIV positive.
- Oral hypoglycaemic agent within 4 weeks prior to signing the consent form.
- Who have undergone pancreatectomy or pancreas/islet cell transplant.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wockhardtlead
Study Sites (25)
University Clinical Investigators, Inc. dba Diabetes Research Center
Tustin, California, 92780, United States
International Research Associates
Hialeah, Florida, 33012, United States
The Center for Diabetes and Endocrine Care
Hollywood, Florida, 33021, United States
Baptist Diabetes Associates, PA
Miami, Florida, 33156, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, 32174, United States
Suncoast Clinical Research
Palm Harbor, Florida, 34684, United States
International Clinical Research - US, LLC
Sanford, Florida, 32771, United States
Cotton-O'Neil Clinical Research Center, Diabetes & Endocrinology
Topeka, Kansas, 66606, United States
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, 40503, United States
Endocrine & Metabolic Consultants
Rockville, Maryland, 20852, United States
ActivMed Practices and Research
Haverhill, Massachusetts, 01830, United States
Alzohaili Medical Consultants
Dearborn, Michigan, 48124, United States
ActivMed Practices and Research
Rochester, New Hampshire, 03867, United States
University Diabetes & Endocrine Association
Chattanooga, Tennessee, 37411, United States
Sergio Rovner, MD
El Paso, Texas, 79925, United States
Optimum Clinical Research, Inc.
Salt Lake City, Utah, 84102, United States
Dr Rakesh Sahay
Hyderabad, Andhra Pradesh, 500012, India
Dia Care - A Complete Diabetes Care Centre
Ahmedabad, Gujarat, 380015, India
Dr Sanjay Kalra
Karnāl, Haryana, 132001, India
Dr Mala Dharmalingam
Bangalore, Karnataka, 560003, India
Bangalore Diabetes Hospital
Bangalore, Karnataka, 560052, India
Dr Sharad Pendsey
Nagpur, Maharashtra, 440012, India
Diabetes Thyroid &Endocrine Centre
Jaipur, Rajasthan, 302006, India
Bhandari's Clinic
Jaipur, Rajasthan, 302015, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ashima Bhatia, M.D.
Wockhardt
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2011
First Posted
March 4, 2011
Study Start
March 1, 2011
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
June 23, 2023
Record last verified: 2023-06