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

An Open Label, Randomized Comparison of Wockhardt's Recombinant Insulin Analogue With Innovator's Glargine in Type 1 Diabetic Patients.

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01352663

Enrollment

Registered

2011-05-12

Start date

Unknown

Completion date

Unknown

Last updated

2019-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type I Diabetes

Keywords

Type I Diabetes, Wockhardt, Insulin Analogue

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.

Interventions

BIOLOGICALWockhardt's Insulin Analogue (Recomb)

Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously.

BIOLOGICALLantus®

Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

1. Patients who have been pre-diagnosed as cases of type-1 diabetes for a period not less than 1 year 2. Male or Female Patients \>= 18 and =\< 55 years of age. 3. Patients with BMI of 18.0 to 30.0 kg/m2 4. Patients who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures.

Exclusion criteria

1. A Patient who is pregnant or is currently breast-feeding. 2. A Patient with history of severe hypoglycemia within the past year 3. 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. 4. Patients who are Hepatitis B or C positive on testing or have positive medical history of HIV at screening. 5. Patients unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026