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Immunosafety Study of Recombinant Human Insulins in Type 1 Diabetics

Information source: Wockhardt
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type I Diabetes

Intervention: Wosulin (N or 70/30 with R) (Biological); Novolin® (N or 70/30 with R) (Biological)

Phase: Phase 3

Status: Terminated

Sponsored by: Wockhardt

Official(s) and/or principal investigator(s):
Ashima Bhatia, M.D., Study Director, Affiliation: Wockhardt

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. The study will last for 54 weeks for the patients enrolled in Wosulin arm and approximately 28 weeks for the patients enrolled in the comparator arm. Two hundred and forty two patients will be enrolled considering an estimated dropout rate of 15% for a sample size of approximately 105 evaluable patients per arm. The total planned enrollment period for this study is approximately 3 months (90 days).

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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).

Secondary outcome:

Correlation between change in HbA1c and change in anti insulin and insulin neutralizing antibodies.

To compare the change from baseline in the level of serum anti insulin antibodies and insulin neutralizing antibodies between the two arms

Compare the change in Insulin dose between the two arms

Correlation of the immunogenicity with hypoglycemia, local allergic reactions and systemic allergic reactions will be evaluated.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Subjects who understand the nature of the study and are willing to provide written informed consent. 2. Subjects who have been pre-diagnosed as cases of type-1 diabetes (fasting C-peptide < 0. 5 nmol/L) and have been on an insulin regimen for at least 12 months prior to inclusion in the trial. 3. 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%). 4. Male or female subjects ≥ 18 and < 55 years of age. 5. Subjects with body mass index (BMI) of ≥18. 0 to < 35. 0 kg/m2 6. Subjects with glycosylated hemoglobin (HbA1c) levels between ≥6. 5 and < 9. 5% 7. Subjects who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures. 8. 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: 1. Women of childbearing potential on an acceptable method of birth control (including but not limited to barrier-method, contraceptives, or intrauterine device) 2. Women with history of bilateral tubal ligation, 3. Women who have undergone total hysterectomy 4. Women who are two years post-menopausal 9. Subjects who are able to use the self glucose-monitoring device and to self inject insulin. Exclusion Criteria: 1. Female subjects who are pregnant (as confirmed by a positive urine and serum β-HCG) or are currently breast-feeding. 2. 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. 3. Employee of Investigator or have direct involvement with trial or other trials under the direction of Investigator. 4. 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. 5. History or evidence of allergy to insulin preparations. 6. History or evidence of severe hypoglycemia (severe hypoglycemic episode defined as the subject required glucose, glucagon, orange juice etc administered by a second person) 7. Requirement for total daily dose of insulin is >1. 4 units/kg 8. 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. 9. Serum AIA level > 20 microU/ml. 10. Receipt of any insulin of an animal origin during the last 3 years. 11. 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). 12. Hepatitis B or Hepatitis C or HIV positive. 13. Oral hypoglycaemic agent within 4 weeks prior to signing the consent form. 14. Who have undergone pancreatectomy or pancreas/islet cell transplant. 15. Unlikely to comply with the study protocol e. g. unable to return periodically for subsequent visits. 16. History or evidence of active severe proliferative retinopathy, nephropathy and/or neuropathy significant cardiovascular disease, anemia or hemoglobinopathy, uncontrolled hypothyroidism or uncontrolled hyperthyroidism, alcohol or drug abuse or any other medical condition that in the opinion of Investigator can interfere with the study. 17. Judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.

Locations and Contacts

Dr Rakesh Sahay, Hyderabad, Andhra Pradesh 500012, India

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 Richie, 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

Dia Care - A Complete Diabetes Care Centre, Ahmedabad, Gujrat 380015, India

Dr Sanjay Kalra, Karnal, Haryana 132001, India

Cotton-O'Neil Clinical Research Center, Diabetes & Endocrinology, Topeka, Kansas 66606, United States

Bangalore Diabetes Hospital, Bangalore, Karnataka 560052, India

Dr Mala Dharmalingam, Bangalore, Karnataka 560003, India

Kentucky Diabetes Endocrinology Center, Lexington, Kentucky 40503, United States

Dr Sharad Pendsey, Nagpur, Maharashtra 440012, India

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

Bhandari's Clinic, Jaipur, Rajasthan 302015, India

Diabetes Thyroid &Endocrine Centre, Jaipur, Rajasthan 302006, India

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

Additional Information

Starting date: March 2011
Last updated: August 21, 2013

Page last updated: August 23, 2015

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