Type I DiabetesPhase 3NCT01352663
Immunogenicity Safety Study of Wockhardt's Recombinant Insulin Analogue in Type 1 Diabetic Patients
A Phase 3 study testing Wockhardt's Insulin Analogue (Recomb) and Lantus® in people with Type I Diabetes, run by Wockhardt.
Trial summary
This is an open label, randomized, parallel group comparison of the immunogenicity safety of Wockhardt's Recombinant Insulin Analogue with the innovator's Glargine in Type 1 diabetics patients. 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?
- Wockhardt's Insulin Analogue (Recomb) and Lantus®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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
- Patients who have been pre-diagnosed as cases of type-1 diabetes for a period not less than 1 year
- Male or Female Patients >= 18 and =< 55 years of age.
- Patients with BMI of 18.0 to 30.0 kg/m2
- Patients who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures.
Who cannot join
- A Patient who is pregnant or is currently breast-feeding.
- A Patient with history of severe hypoglycemia within the past year
- A Patient who is an employee of the Investigator, or a patient who has a direct involvement with the trial or other trials under the direction of the Investigator.
- Patients who are Hepatitis B or C positive on testing or have positive medical history of HIV at screening.
- Patients unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.
About this study
Official title: An Open Label, Randomized Comparison of Wockhardt's Recombinant Insulin Analogue With Innovator's Glargine in Type 1 Diabetic Patients.
This is an open label, randomized, parallel group comparison of the immunogenicity safety of Wockhardt's Recombinant Insulin Analogue with the innovator's Glargine in Type 1 diabetics patients.
Read the detailed description
To evaluate and compare the Immunogenicity Safety of Wockhardt's Recombinant Insulin Analogue with innovator's Glargine.
- Conditions
- Type I Diabetes
- Being tested
- Wockhardt's Insulin Analogue (Recomb), Lantus®
- Keywords
- Type I Diabetes, Wockhardt, Insulin Analogue
- 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.
Wockhardt's Insulin Analogue (Recomb)Biological
Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously.
Lantus®Biological
Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Wockhardt's Insulin Analogue (Recomb) | Experimental | Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously. Receives: Biological: Wockhardt's Insulin Analogue (Recomb) |
| Lantus® | Active comparator | Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously. Receives: Biological: Lantus® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbAlc from baseline till the end of treatment period.
Measured: 12 months
Secondary outcomes (1)
Percentage change in immunogenic response.
Evaluating antibodies titre.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
Why it stopped: Business strategy decision
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Ashima Bhatia, M.D., Study director, Wockhardt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352663
- Sponsor's protocol ID
- P3-GLR-IMSFDA-01
- Status last verified
- Oct 2019
- First submitted
- 9 May 2011
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized Comparison of Wockhardt's Recombinant Insulin Analogue With Innovator's Glargine in Type 1 Diabetic Patients.
- ClinicalTrials.gov ID
- NCT01352663
- Acronym / sponsor ID
- P3-GLR-IMSFDA-01
- Conditions
- Type I Diabetes
- Keywords
- Type I Diabetes, Wockhardt, Insulin Analogue
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business strategy decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- First posted
- 12 May 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 Recombinant Insulin Analogue with the innovator's Glargine in Type 1 diabetics patients.
Detailed description
To evaluate and compare the Immunogenicity Safety of Wockhardt's Recombinant Insulin Analogue with innovator's Glargine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wockhardt's Insulin Analogue (Recomb) | Experimental | Biological: Wockhardt's Insulin Analogue (Recomb)Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously. |
| Lantus® | Active comparator | Biological: Lantus®Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients who have been pre-diagnosed as cases of type-1 diabetes for a period not less than 1 year
- Male or Female Patients >= 18 and =< 55 years of age.
- Patients with BMI of 18.0 to 30.0 kg/m2
- Patients who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures.
Key exclusion criteria (5 listed)
- A Patient who is pregnant or is currently breast-feeding.
- A Patient with history of severe hypoglycemia within the past year
- A Patient who is an employee of the Investigator, or a patient who has a direct involvement with the trial or other trials under the direction of the Investigator.
- Patients who are Hepatitis B or C positive on testing or have positive medical history of HIV at screening.
- Patients unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.
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 |
|---|---|---|
| Wockhardt's Insulin Analogue (Recomb)Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously. | Biological | Wockhardt's Insulin Analogue (Recomb) |
| Lantus®Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously. | Biological | Lantus® |
Primary outcome
Change in HbAlc from baseline till the end of treatment period.
Time frame: 12 months
1 secondary outcome
Percentage change in immunogenic response.
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
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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.
Dr Ashima Bhatia, M.D. study director
Wockhardt
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Wockhardt's Insulin Analogue (Recomb) and Lantus® in people with Type I Diabetes, run by Wockhardt.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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 till the end of treatment period. (time frame: 12 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 8 Oct 2019.