Immunogenicity Safety Study of Wockhardt's Recombinant In... | NCT01352663

Studies
Immunogenicity Safety Study of Wockhardt's Recombinant Insulin Analogue in Type 1 Diabetic Patients

NCT01352663

Sponsor

Wockhardt

Status

Withdrawn

Last Update Posted

Oct 8, 2019Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Type I Diabetes

Interventions

Wockhardt's Insulin Analogue (Recomb)
Lantus®

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Business strategy decision

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 9, 2011

First Submission Date that Met QC Criteria

May 10, 2011

First Posted Date

May 12, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2019

Last Update Posted Date

Oct 8, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

To evaluate and compare the Immunogenicity Safety of Wockhardt's Recombinant Insulin Analogue with innovator's Glargine.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Wockhardt's Insulin Analogue (Recomb)	Experimental	Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously.	Biological: Wockhardt's Insulin Analogue (Recomb)
Lantus®	Active Comparator	Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously.	Biological: Lantus®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Wockhardt's Insulin Analogue (Recomb)	Biological	Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously.	Wockhardt's Insulin Analogue (Recomb)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in HbAlc from baseline till the end of treatment period.		12 months

Secondary Outcomes

Measure	Description	Time Frame
Percentage change in immunogenic response.	Evaluating antibodies titre.	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Dr Ashima Bhatia, M.D.	Wockhardt	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069036	Insulin Glargine

Ancestor Terms

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided