Trials / Withdrawn
WithdrawnNCT01352663
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- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Wockhardt · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Wockhardt's Insulin Analogue (Recomb) | Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously. |
| BIOLOGICAL | Lantus® | Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously. |
Timeline
- First posted
- 2011-05-12
- Last updated
- 2019-10-08
Source: ClinicalTrials.gov record NCT01352663. Inclusion in this directory is not an endorsement.