Immunosafety Study of Recombinant Human Insulins in Type 1 Diabetics
Public ClinicalTrials.gov record NCT01308437. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open Label,Randomized,Comparison of the Immunogenicity and Safety of Wockhardt's Human Insulin Basal Bolus Regimen With the Novo Nordisk's Yeast Based Human Insulin Basal Bolus Regimens, Marketed in United States, in Type 1 Diabetics.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open label, randomized, parallel group comparison of the immunogenicity safety of Wockhardt's human insulin and isophane insulin compared with the Novo Nordisk's yeast based human insulin products (marketed in USA) in type 1 diabetics. There are two phases of the study, which are as follows: 1. Phase 1 is a comparative phase in which there will be 2 arms (which are described in the section below). 2. Phase 2 is a follow up phase only applicable to Wosulin Arm. The study will last for 54 weeks for the patients enrolled in Wosulin arm and approximately 28 weeks for the patients enrolled in the comparator arm. Two hundred and forty two patients will be enrolled considering an estimated dropout rate of 15% for a sample size of approximately 105 evaluable patients per arm. The total planned enrollment period for this study is approximately 3 months (90 days).
Study identification
- NCT ID
- NCT01308437
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 134 participants
Conditions and interventions
Conditions
Interventions
- Wosulin (N or 70/30 with R) Biological
- Novolin® (N or 70/30 with R) Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2011 (Type not available)
- Primary completion
- Apr 2013 (Actual)
- Completion
- Apr 2013 (Actual)
- Last update posted
- Jun 23, 2023
2011 – 2013
United States locations
- U.S. sites
- 17
- U.S. states
- 11
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University Clinical Investigators, Inc. dba Diabetes Research Center | Tustin | California | 92780 | — |
| International Research Associates | Hialeah | Florida | 33012 | — |
| The Center for Diabetes and Endocrine Care | Hollywood | Florida | 33021 | — |
| Baptist Diabetes Associates, PA | Miami | Florida | 33156 | — |
| Suncoast Clinical Research | New Port Richey | Florida | 34652 | — |
| Ormond Medical Arts Pharmaceutical Research Center | Ormond Beach | Florida | 32174 | — |
| Suncoast Clinical Research | Palm Harbor | Florida | 34684 | — |
| International Clinical Research - US, LLC | Sanford | Florida | 32771 | — |
| Cotton-O'Neil Clinical Research Center, Diabetes & Endocrinology | Topeka | Kansas | 66606 | — |
| Kentucky Diabetes Endocrinology Center | Lexington | Kentucky | 40503 | — |
| Endocrine & Metabolic Consultants | Rockville | Maryland | 20852 | — |
| ActivMed Practices and Research | Haverhill | Massachusetts | 01830 | — |
| Alzohaili Medical Consultants | Dearborn | Michigan | 48124 | — |
| ActivMed Practices and Research | Rochester | New Hampshire | 03867 | — |
| University Diabetes & Endocrine Association | Chattanooga | Tennessee | 37411 | — |
| Sergio Rovner, MD | El Paso | Texas | 79925 | — |
| Optimum Clinical Research, Inc. | Salt Lake City | Utah | 84102 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01308437, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 23, 2023 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01308437 live on ClinicalTrials.gov.