Type I DiabetesPhase 3NCT01308437
Immunosafety Study of Recombinant Human Insulins in Type 1 Diabetics
A Phase 3 study testing Wosulin (N or 70/30 with R) and Novolin® (N or 70/30 with R) in people with Type I Diabetes, run by Wockhardt at 25 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Type I Diabetes
- What is being tested?
- Wosulin (N or 70/30 with R) and Novolin® (N or 70/30 with R)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Mar 2011to Apr 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects who understand the nature of the study and are willing to provide written informed consent.
- 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.
- 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%
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- 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.
Who cannot join
- 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.
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- 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.
- Unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.
- 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.
- Judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States17 sites
University Diabetes & Endocrine Association
Chattanooga, Tennessee, 37411
Alzohaili Medical Consultants
Dearborn, Michigan, 48124
Sergio Rovner, MD
El Paso, Texas, 79925
ActivMed Practices and Research
Haverhill, Massachusetts, 01830
International Research Associates
Hialeah, Florida, 33012
The Center for Diabetes and Endocrine Care
Hollywood, Florida, 33021
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, 40503
Baptist Diabetes Associates, PA
Miami, Florida, 33156
Suncoast Clinical Research
New Port Richey, Florida, 34652
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, 32174
Suncoast Clinical Research
Palm Harbor, Florida, 34684
ActivMed Practices and Research
Rochester, New Hampshire, 03867
Endocrine & Metabolic Consultants
Rockville, Maryland, 20852
Optimum Clinical Research, Inc.
Salt Lake City, Utah, 84102
International Clinical Research - US, LLC
Sanford, Florida, 32771
Cotton-O'Neil Clinical Research Center, Diabetes & Endocrinology
Topeka, Kansas, 66606
University Clinical Investigators, Inc. dba Diabetes Research Center
Tustin, California, 92780
India8 sites
Dia Care - A Complete Diabetes Care Centre
Ahmedabad, Gujarat, 380015
Dr Mala Dharmalingam
Bangalore, Karnataka, 560003
Bangalore Diabetes Hospital
Bangalore, Karnataka, 560052
Dr Rakesh Sahay
Hyderabad, Andhra Pradesh, 500012
Diabetes Thyroid &Endocrine Centre
Jaipur, Rajasthan, 302006
Bhandari's Clinic
Jaipur, Rajasthan, 302015
Dr Sanjay Kalra
Karnāl, Haryana, 132001
Dr Sharad Pendsey
Nagpur, Maharashtra, 440012
About this study
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.
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:
Read more
- Phase 1 is a comparative phase in which there will be 2 arms (which are described in the section below).
- 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).
- Conditions
- Type I Diabetes
- Being tested
- Wosulin (N or 70/30 with R), Novolin® (N or 70/30 with R)
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wosulin (N or 70/30 with R)Biological
Also called Wosulin R,, Wosulin N,, Wosulin 70/30
Basal bolus conventional Insulin viz. Wosulin (N or 70/30 with R) to be injected subcutaneously.
Novolin® (N or 70/30 with R)Biological
Also called Novolin® R,, Novolin® N,, Novolin® 70/30
Basal bolus conventional Insulin viz. Novolin® (N or 70/30 with R) to be injected subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Wosulin (N or 70/30 with R) | Experimental | Basal bolus conventional Insulin viz. Wosulin (N or 70/30 with R) to be injected subcutaneously. Receives: Biological: Wosulin (N or 70/30 with R) |
| Novolin® (N or 70/30 with R) | Active comparator | Basal bolus conventional Insulin viz. Novolin® (N or 70/30 with R) to be injected subcutaneously. Receives: Biological: Novolin® (N or 70/30 with R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (4)
Correlation between change in HbA1c and change in anti insulin and insulin neutralizing antibodies.
Insulin dose will be used as a covariate
Measured: 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
Measured: 6 months
Compare the change in Insulin dose between the two arms
Glycated hemoglobin levels and the number of hypoglycemic episodes will be the covariants for this analysis
Measured: 3 and 6 months
Correlation of the immunogenicity with hypoglycemia, local allergic reactions and systemic allergic reactions will be evaluated.
Immunogenicity is measured as percentage change in serum antiinsulin antibodies and insulin neutralizing antibodies.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: Business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type I DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashima Bhatia, M.D., Study director, Wockhardt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308437
- Sponsor's protocol ID
- P3-WOS-IMS-01
- Status last verified
- Jun 2023
- First submitted
- 9 Feb 2011
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01308437
- Acronym / sponsor ID
- P3-WOS-IMS-01
- Conditions
- Type I Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reasons
- Enrolment
- 134 participants (actual)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 4 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Phase 1 is a comparative phase in which there will be 2 arms (which are described in the section below).
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wosulin (N or 70/30 with R) | Experimental | Biological: Wosulin (N or 70/30 with R)Basal bolus conventional Insulin viz. Wosulin (N or 70/30 with R) to be injected subcutaneously. |
| Novolin® (N or 70/30 with R) | Active comparator | Biological: Novolin® (N or 70/30 with R)Basal bolus conventional Insulin viz. Novolin® (N or 70/30 with R) to be injected subcutaneously. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subjects who understand the nature of the study and are willing to provide written informed consent.
- 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.
- 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
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wosulin (N or 70/30 with R)Also: Wosulin R,, Wosulin N,, Wosulin 70/30Basal bolus conventional Insulin viz. Wosulin (N or 70/30 with R) to be injected subcutaneously. | Biological | Wosulin (N or 70/30 with R) |
| Novolin® (N or 70/30 with R)Also: Novolin® R,, Novolin® N,, Novolin® 70/30Basal bolus conventional Insulin viz. Novolin® (N or 70/30 with R) to be injected subcutaneously. | Biological | Novolin® (N or 70/30 with R) |
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).
Time frame: 6 months
4 secondary outcomes
Correlation between change in HbA1c and change in anti insulin and insulin neutralizing antibodies.
Time frame: 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
Time frame: 6 months
Compare the change in Insulin dose between the two arms
Time frame: 3 and 6 months
Correlation of the immunogenicity with hypoglycemia, local allergic reactions and systemic allergic reactions will be evaluated.
Time frame: 6 and 12 months
Results and safety
The study was stopped early (reason given: Business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashima Bhatia, M.D. study director
Wockhardt
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Wosulin (N or 70/30 with R) and Novolin® (N or 70/30 with R) in people with Type I Diabetes, run by Wockhardt at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.