Type I Diabetes
Conditions
Keywords
Type I Diabetes, Wockhardt's Insulin analogue Lispro, Humalog®, Humalog Mix, Wockhardt, Biosimilar, Phase 3
Brief 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
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.
Interventions
BIOLOGICALInsulin Lispro
a. Lispro and Lispro Mix® 75/25 / Lispro Mix 50/50 The drugs would be administered subcutaneously
Sponsors
Wockhardt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who understand the nature of the study and are willing to provide written informed consent. 2. Patients who have been pre-diagnosed as cases of type-1 diabetes for a period not less than 1 year 3. Male or Female Patients ≥ 18 and \< 55 years of age. 4. Patients with body mass index (BMI) of 18.0 to 30.0 kg/m2 5. Patients who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures. 6. Ability to use the self glucose-monitoring device and to self inject insulin.
Exclusion criteria
1. Females who are pregnant or lactating, or not practicing adequate contraception. 2. A Patient with compromised hepatic or renal function 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. 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. 5. A Patient with history or evidence of allergy to insulin preparations. 6. A Patients who is currently receiving or has received, within the last year, any immunomodulator medications. 7. Patients unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits. 8. Patients who are judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change in the immunogenic response | 6 months |
| Correlation of the immunogenicity with hypoglycemia | 12 months |
Outcome results
None listed