Type I DiabetesPhase 3NCT01398670

Immunogenicity Study of Wockhardt's Insulin Lispro/Lispro Mix Basal Bolus Regimen in Type 1 Diabetics

A Phase 3 study testing Insulin Lispro in people with Type I Diabetes, run by Wockhardt.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

This is a randomized, parallel group comparison of the immunogenicity safety of Wockhardt's Insulin analogue Lispro and lispro Mix with Eli Lilly's Insulin analogue Humalog® and Humalog® Mix in patients with Type 1 Diabetes Mellitus 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?: Insulin Lispro
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: Feb 2012to May 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

Patients who understand the nature of the study and are willing to provide written informed consent.
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 body mass index (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.
Ability to use the self glucose-monitoring device and to self inject insulin.

Who cannot join

Females who are pregnant or lactating, or not practicing adequate contraception.
A Patient with compromised hepatic or renal function
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.
A Patient who has been treated with other investigational agent or devices within the previous 30 days, has planned use of investigational drugs or devices, or has been previously randomized in this trial.
A Patient with history or evidence of allergy to insulin preparations.
A Patients who is currently receiving or has received, within the last year, any immunomodulator medications.
Patients unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.
Patients who are judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned.

About this study

Official title: Comparison of the Immunogenicity of Wockhardt's Insulin Analogue Lispro and Lispro Mix With Eli Lilly's Insulin Analogue Humalog® and Humalog® Mix in Type 1 Diabetic Patients

Read the detailed description

To evaluate and compare the Immunogenicity safety of Wockhardt's Insulin analogue Lispro and lispro Mix with Eli Lilly's Insulin analogue Humalog® and Humalog® Mix in Type I Diabetic patients.

Conditions: Type I Diabetes
Being tested: Insulin Lispro
Keywords: Type I Diabetes, Wockhardt's Insulin analogue Lispro, Humalog®, Humalog Mix, Wockhardt, Biosimilar, Phase 3
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.

Insulin LisproBiological
1. Lispro and Lispro Mix® 75/25 / Lispro Mix 50/50
The drugs would be administered subcutaneously
Insulin LisproBiological
Humalog® and Humalog® Mix75/25 /Humalog® Mix 50/50
The drugs would be administered subcutaneously

Study groups in NCT01398670
Study group	Role	What they receive
Lispro arm	Experimental	Lispro and Lispro Mix 75/25 /Lispro Mix 50/50 Receives: Biological: Insulin Lispro
Humalog® arm	Active comparator	Humalog® and Humalog® Mix75/25 / Humalog® Mix50/50 Receives: Biological: Insulin Lispro

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in HbA1c
Measured: 6 months

Secondary outcomes (2)

Percentage change in the immunogenic response
Measured: 6 months
Correlation of the immunogenicity with hypoglycemia
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012May 2013

First posted20 Jul 2011 (estimated)
Study startFeb 2012
Primary completionMar 2013 (estimated)
Study completionMay 2013 (estimated)

Why it stopped: Study was not initiated

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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01398670
Sponsor's protocol ID: P3-LIS-IMSFDA-01
Status last verified: Jan 2013
First submitted: 19 Jul 2011
Last updated: 25 Jan 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Type I Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Immunogenicity of Wockhardt's Insulin Analogue Lispro and Lispro Mix With Eli Lilly's Insulin Analogue Humalog® and Humalog® Mix in Type 1 Diabetic Patients
ClinicalTrials.gov ID: NCT01398670
Acronym / sponsor ID: P3-LIS-IMSFDA-01
Conditions: Type I Diabetes
Keywords: Type I Diabetes, Wockhardt's Insulin analogue Lispro, Humalog®, Humalog Mix, Wockhardt, Biosimilar, Phase 3
Phase: Phase 3
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Study was not initiated
Enrolment: 0 participants (actual)
Lead sponsor: WockhardtIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Mar 2013 (estimated)
Study completion: May 2013 (estimated)
First posted: 20 Jul 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.

Detailed description

To evaluate and compare the Immunogenicity safety of Wockhardt's Insulin analogue Lispro and lispro Mix with Eli Lilly's Insulin analogue Humalog® and Humalog® Mix in Type I Diabetic patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Lispro arm	Experimental	Biological: Insulin LisproLispro and Lispro Mix 75/25 /Lispro Mix 50/50
Humalog® arm	Active comparator	Biological: Insulin LisproHumalog® and Humalog® Mix75/25 / Humalog® Mix50/50

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Patients who understand the nature of the study and are willing to provide written informed consent.
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 body mass index (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 (8 listed)

Females who are pregnant or lactating, or not practicing adequate contraception.
A Patient with compromised hepatic or renal function
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.
A Patient who has been treated with other investigational agent or devices within the previous 30 days, has planned use of investigational drugs or devices, or has been previously randomized in this trial.
A Patient with history or evidence of allergy to insulin preparations.

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
Insulin Lisproa. Lispro and Lispro Mix® 75/25 / Lispro Mix 50/50 The drugs would be administered subcutaneously	Biological	Lispro arm
Insulin LisproHumalog® and Humalog® Mix75/25 /Humalog® Mix 50/50 The drugs would be administered subcutaneously	Biological	Humalog® arm

Primary outcome

Change in HbA1c
Time frame: 6 months

2 secondary outcomes

Percentage change in the immunogenic response
Time frame: 6 months
Correlation of the immunogenicity with hypoglycemia
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 25 Jan 2013.

Related trials for Type I Diabetes

RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
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RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
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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.Rasendrakumar Jha study director

Wockhardt

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin Lispro 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 6 inclusion and 8 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 25 Jan 2013. 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 HbA1c (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01398670.

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 25 Jan 2013.